David R.

Hardten, MD, FACS

Minnesota Eye Consultants, PA
Minneapolis, Minnesota
Regions Medical Center
St. Paul, Minnesota
University of Minnesota
Minneapolis, Minnesota

Richard L. Lindstrom, MD
Minnesota Eye Consultants, PA
Minneapolis, Minnesota
Regions Medical Center
St. Paul, Minnesota
University of Minnesota
Minneapolis, Minnesota

Elizabeth A. Davis, MD, FACS

Minnesota Eye Consultants, PA
Minneapolis, Minnesota
University of Minnesota
Minneapolis, Minnesota

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Phakic intraocular lenses : principles and practice / [edited by] David

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1. Intraocular lenses. 2. Eye--Refractive errors--Surgery.
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CONTENTS
Dedication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
About the Editors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi
Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Preface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Chapter 1 Demographics of Refractive Surgery: The Role of Phakic Intraocular Lenses . . . . . . . . . . 1

David Rex Hamilton, MD, MS; David R. Hardten, MD, FACS; and Richard L. Lindstrom, MD

Chapter 2 The History of Phakic Intraocular Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Patricia Sierra Wilkinson, MD and David R. Hardten, MD, FACS

Chapter 3 Patient Selection for Phakic Intraocular Lenses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Brian J. Snyder, OD and Elizabeth A. Davis, MD, FACS

Chapter 4 Preoperative Diagnostic Testing for Phakic Intraocular Lenses . . . . . . . . . . . . . . . . . . . . 29

Tina M. McCarty, OD, FAAO and David R. Hardten, MD, FACS

Chapter 5 Optics and Intraocular Lens Power Calculations for Phakic Intraocular Lenses . . . . . . . . 37
Jack T. Holladay, MD, MSEE, FACS

Chapter 6 Anesthesia for Phakic Intraocular Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Nicole J. Anderson, MD and C. Joseph Anderson, MD

Chapter 7 Astigmatism Management at the Time of Phakic Intraocular Lenses . . . . . . . . . . . . . . . . 57

Louis D. Nichamin, MD

Chapter 8 Comparison of Phakic Intraocular Lenses With Corneal Refractive Surgery . . . . . . . . . . 67

Louis E. Probst, MD

Chapter 9 Complications of Phakic Intraocular Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

Thomas Kohnen, MD; Alireza Mirshahi, MD; Jens Bühren, MD;
Thomas Kasper, MD; and Martin Baumeister, MD

Chapter 10 Postoperative Care for Phakic Intraocular Lens Implants . . . . . . . . . . . . . . . . . . . . . . . . 99

Vance Thompson, MD

Chapter 11 Comparison of Refractive Outcomes and Complications Among

Current Phakic Intraocular Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
Anthony J. Lombardo, MD, PhD

Chapter 12 Implantable Contact Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

John A. Vukich, MD and Donald R. Sanders, MD, PhD

Chapter 13 The Artisan Phakic Intraocular Lens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Maria M. Braun, MD and Edward E. Manche, MD

Chapter 14 CIBA Vision Phakic Refractive Lens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

Gary S. Schwartz, MD and Stephen S. Lane, MD
 Contents v

Chapter 15 Baïkoff’s Foldable Anterior Chamber Phakic Intraocular Lenses for

Myopia, Hyperopia, and Presbyopia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
Georges D. Baïkoff, MD

Chapter 16 Angle-Supported Phakic Intraocular Lenses: The Phakic 6H2. . . . . . . . . . . . . . . . . . . . 163

Sujata S. Purohit, MD; Raymund T. Angeles, MD; Alan C. Westeren, MD;
Jay McDonald, MD; Daniel B. Tran, MD; Tom Clinch, MD; and David J. Schanzlin, MD

Chapter 17 Other Types of Phakic Intraocular Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171

David Rex Hamilton, MD, MS and Elizabeth A. Davis, MD, FACS

Chapter 18 Bioptics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177

Roberto Zaldivar, MD; Susana Oscherow, MD; and Virginia Piezzi, MD

Chapter 19 Refractive Lens Exchange . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

Mark Packer, MD; Richard S. Hoffman, MD; and I. Howard Fine, MD

Chapter 20 Use of Phakic Intraocular Lenses in Pseudophakic Eyes . . . . . . . . . . . . . . . . . . . . . . . . 199

Patricia Sierra Wilkinson, MD and David R. Hardten, MD, FACS

Chapter 21 The Future of Phakic Intraocular Lenses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205

David Rex Hamilton, MD, MS; David R. Hardten, MD, FACS;
Elizabeth A. Davis, MD, FACS; and Richard L. Lindstrom, MD

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
 ABOUT THE EDITORS
Drs. Hardten, Lindstrom, and Davis have over 5 years of experience with phakic intraocular lenses (IOLs) in their
practice at Minnesota Eye Consultants in Minneapolis as part of the clinical trials for phakic IOLs in the United States.
All of the authors also have extensive experience in other forms of refractive surgery, including radial keratotomy, laser
in-situ keratomileusis (LASIK), photorefractive keratectomy (PRK), laser epithelial keratomileusis (LASEK), Intacs,
refractive lens exchange, and conductive keratoplasty to put the phakic IOL experience in perspective. They have also
all held leadership positions in organizations that have shaped refractive surgery, including the International Society of
Refractive Surgery, Refractive Surgery Interest Group, International Intraocular Implant Club, American Society of
Cataract and Refractive Surgery, and the American Academy of Ophthalmology.
 CONTRIBUTORS
C. Joseph Anderson, MD Jack T. Holladay, MD, MSEE, FACS
Anderson & Shapiro Eye Care Clinical Professor of Ophthalmology
Madison, Wis Baylor College of Medicine
Houston, Tex
Nicole J. Anderson, MD
Mississippi Vision Correction Center Thomas Kasper, MD
Jackson, Miss Department of Ophthalmology
Johann Wolfgang Goethe-University
Raymund T. Angeles, MD Frankfurt am Main, Germany
Shiley Eye Center
University of California Thomas Kohnen, MD
San Diego, Calif Department of Ophthalmology
Johann Wolfgang Goethe-University
Georges D. Baïkoff, MD Frankfurt am Main, Germany
Clinic Monticelli
Marseilles, France Stephen S. Lane, MD
Associated Eye Care
Martin Baumeister, MD Stillwater, Minn
Department of Ophthalmology Clinical Professor
Johann Wolfgang Goethe-University University of Minnesota
Frankfurt am Main, Germany Minneapolis, Minn

Maria M. Braun, MD Anthony J. Lombardo, MD, PhD

Private Practice Eye Surgeons of Indiana
Fairfax, Va Indianapolis, Ind

Jens Bühren, MD Edward E. Manche, MD

Department of Ophthalmology Assistant Professor and Director of Refractive Surgery
Johann Wolfgang Goethe-University and Cornea/External Disease
Frankfurt am Main, Germany Department of Ophthalmology
Stanford University School of Medicine
Tom Clinch, MD Stanford, Calif
Shiley Eye Center
University of California Tina M. McCarty, OD, FAAO
San Diego, Calif Clinical Director
TLC Laser Eye Centers
I. Howard Fine, MD Minneapolis, Minn
Drs. Fine, Hoffman & Packer, LLC
Eugene, Ore Jay McDonald, MD
Shiley Eye Center
David Rex Hamilton, MD, MS University of California
Director, Laser Refractive Center San Diego, Calif
Assistant Professor of Ophthalmology
The Jules Stein Eye Institute Alireza Mirshahi, MD
David Geffen School of Medicine at UCLA Department of Ophthalmology
Los Angeles, Calif Johann Wolfgang Goethe-University
Frankfurt am Main, Germany
Richard S. Hoffman, MD
Drs. Fine, Hoffman & Packer, LLC Louis D. Nichamin, MD
Eugene, Ore Medical Director, Laurel Eye Clinic
Brookville, Pa
viii Contributors

Susana Oscherow, MD Brian J. Snyder, OD

Research and Biostatistics Department Minnesota Eye Consultants, PA
Instituto Zaldivar SA Minneapolis, Minn
Mendoza, Argentina
Vance Thompson, MD
Mark Packer, MD Director of Refractive Surgery
Drs. Fine, Hoffman & Packer, LLC Ophthalmology Ltd
Eugene, Ore Sioux Falls, SD
Assistant Professor of Ophthalmology
Virginia Piezzi, MD University of South Dakota School of Medicine
Instituto Zaldivar SA Sioux Falls, SD
Mendoza, Argentina
Daniel B. Tran, MD
Louis E. Probst, MD Shiley Eye Center
Medical Director, TLCVision University of California
Ann Arbor, Mich San Diego, Calif

Sujata S. Purohit, MD John A. Vukich, MD

Shiley Eye Center Surgical Director, Davis Duehr Dean Center for
University of California Refractive Surgery
San Diego, Calif Davis Duehr Dean Department of Ophthalmology
Dean Medical Center
Donald R. Sanders, MD, PhD Madison, Wis
Center for Clinical Research
Elmhurst, Ill Alan C. Westeren, MD
Shiley Eye Center
David J. Schanzlin, MD University of California
Shiley Eye Center San Diego, Calif
University of California
San Diego, Calif Patricia Sierra Wilkinson, MD
Cornea and Refractive Surgery Fellow
Gary S. Schwartz, MD Minnesota Eye Consultants, PA
Associated Eye Care Phillips Eye Institute
Saint Paul, Minn Minneapolis, Minn
Clinical Assistant Professor
University of Minnesota Roberto Zaldivar, MD
Minneapolis, Minn Scientific Director
Instituto Zaldivar SA
Mendoza, Argentina
 PREFACE
Refractive surgery has experienced considerable and rapid growth in the past decade, with over 1 million procedures
being performed yearly. Currently, there are a variety of methods available to treat different refractive errors. Phakic
IOLs are becoming an important addition to the repertoire of refractive procedures. They expand the range of refrac-
tive errors that can be corrected to much higher levels. Additionally, the quality of vision they produce may be superi-
or to laser ablative procedures at these levels of correction because phakic IOLs preserve the prolate shape of the cornea.
There are several lenses that are currently undergoing clinical trials in the United States, and there are models that
are commonly used outside the United States that are not yet in clinical trials. Results from the US Food and Drug
Administration (FDA) trials show excellent safety and predictability for these lenses. Not only are patients achieving
good uncorrected vision, but the majority experience an improvement in their best-corrected acuity compared to pre-
operative levels. As with any surgical procedure, complications are possible. However, with proper screening, surgical
technique, and postoperative care, the incidence of significant problems is low.
This textbook, Phakic Intraocular Lenses: Principles and Practice, presents the current science of this field. The basics
of phakic IOLs, the history of phakic IOLs, patient selection, preoperative testing, and IOL power calculation are
described in the initial chapters. Subsequent chapters discuss postoperative care, complications, and comparisons to
LASIK and comparisons amongst different phakic IOLs. The final chapters present the individual phakic IOLs in trials
or in development.
We believe that the time is right for a text of this type, as phakic IOLs are now coming into common practice
throughout the world. Improvements in safety and techniques have moved forward dramatically, and phakic IOLs are
now a real consideration for your patients. Because of the rapid advances in the field, we have tried to provide perspec-
tive and references that will serve the reader well in the long run, but also as a springboard to understanding any recent
innovations in this rapidly changing technology.
We hope that this book will provide both novice and experienced refractive surgeons with useful information that
they can apply in their practice to help patients improve their quality of life and quality of vision.
David R. Hardten, MD, FACS
Richard Lindstrom, MD
Elizabeth A. Davis, MD, FACS
 FOREWORD
The French philosopher Voltaire once said that “we invent words to conceal truths.” In the context of this volume,
he might have added that “we create texts to examine the truth.”
Phakic intraocular lenses (IOLs) are currently utilized to correct significant ametropia (ie, beyond the scope of LASIK and
therefore are an accepted facet of the refractive surgeon’s armamentarium). However, the role of pseudophakia to correct
aphakia is only a relatively recent event in the history of ophthalmic surgery. Less than three decades ago, lens implantation
for aphakia was still a hostile concept; “a time bomb waiting to explode!” In spite of almost universal hostility, pseudophakia
not only survived but blossomed to become the unquestioned answer for cataract-affected patients. The impetus of lens
implantation could not simply be erased like a mistake in spelling. Unlike so many ideas that perished in their infancy, pha-
kic lens implantation has also survived earlier negative exaggerations that attempted to condemn but ultimately served to
market the proposition. Prescient leaders of refractive surgery, rather than associating themselves with the chilly disappro-
bation of the majority, generated their own frisson of excitement for what phakic lens implantation might achieve for those
many disadvantaged ametropic patients. They were not to be deterred or so easily distracted from their intended purpose by
the bleak insufficiency of a one-dimensional approach to refraction, whilst others were excited by the commercial opportu-
nity born. Phakic implantation was not an idea condemned to perish in its infancy.
Technological advances and pseudophakic experience have each played their part to complement the pioneering
efforts of George Baïkoff in France and Svyatoslov Fyoderov in what was then Soviet Union, amongst others. Their con-
tributions were fundamental and have finally led to universal acceptance of the role of phakic implantation, which now
complements pseudophakic surgery.
In an age where corneal refractive surgery has exploded on the back of increasingly sophisticated laser surgical tech-
nologies, so there has been a much slower but parallel development of phakic implantation. Phakic implant surgery is
additive surgery and therefore potentially reversible, a safety aspect appealing to surgeons and patients alike. The opti-
cal quality of phakic IOL vision would seem to be superior to oblate corneal vision, so much so that the parameters for
corneal laser surgery have receded whilst those for phakic implantation have advanced.
Phakic IOLs may be located in the anterior chamber (ie, angle supported). Arguably, this is the simplest of the sur-
gical procedures but requires a substantial incision and therefore the skills to control the prospect of induced astigma-
tism, anathema to the refractive surgeon. Similarly, the iris-supported “lobster claw” Artisan-type phakic implant also
requires not only a sizeable incision, but additional skills to fixate the IOL by subtle maneuvers. Prevention of induced
astigmatism represents a further surgical challenge. A toric version adds to its potential value aiding the neutralization
of pre-existing astigmatism. Further, a foldable version is imminent. Finally the posterior chamber, which always seemed
to be the most unlikely location for phakic implants, has proved to have important advantages for their use. Small, self-
sealing incisions avoid induced astigmatism, the IOL is invisible to the naked eye, and the optical quality is arguably
superior because of its proximity to the crystalline lens.
Each type of phakic implant has its advocates. Surgeons, being creatures of habit, adopt one of the versions for their
own particular reasons and then the added experience of continued usage invariably persuades them to become advo-
cates for that particular process. This outcome confirms that all the systems are effective, the pros and cons offering the
opportunity for continued animated debates amongst refractive surgeons as well as providing an opportunity for novice
enlightenment.
I congratulate the authors of this volume for its timely production and the combined experience the book brings to
its readership, many of whom will be contemplating adding phakic implant surgery to their repertoire of refractive sur-
gical procedures. For the more experienced surgeons, this volume will allow reflection on their current practice and the
probability of its variation with the desire of all refractive surgeons to customize the surgical process in accordance with
a patient’s visual requirements.
Controversies that will continue are the place of phakic IOLs in presbyopic eyes, the comparisons and respective
safety of refractive lens exchange versus phakic implantation, the value of multifocal phakic implants, phakic implant
surgery versus corneal refractive surgery, and the choice of phakic implant, their design, and location.

Emanual Rosen, MD
Visiting Professor, University of Manchester Institute of Science and Technology
Department of Optometry and Neurosciences
Manchester, UK
Director, Rosen Eye Clinics UK
Past President, International Intraocular Implant Club
Past President, European Society of Cataract & Refractive Surgeons
Coeditor, Journal of Cataract and Refractive Surgery

Demographics of Refractive Surgery:
The Role of Phakic Intraocular Lenses
David Rex Hamilton, MD, MS; David R. Hardten, MD, FACS; and Richard L. Lindstrom, MD
OVERVIEW
Refractive surgery is the most rapidly evolving disci-
pline in ophthalmology today, with 1.3 million procedures
performed in the United States in 2001 and 1.2 million
projected for 2002 (Figure 1-1). Numerous surgical modal-
ities and techniques exist to treat a wide range of refractive
errors. The emergence of phakic intraocular lens (IOL)
technology expands the capabilities of refractive surgery
to address higher levels of myopia and hyperopia than
were previously accessible. In this chapter, we will exam-
ine the demographics of refractive errors, how currently
available surgical techniques address various ranges of
refractive errors, and the role phakic IOLs will play in
bringing effective solutions to patients who might other-
wise be considered suboptimal refractive surgical candi-
dates.
MYOPIA
Definitions
While there is some variability in terminology found in
the literature, the following definitions will be used to
stratify levels of myopia: low (less than -5.00 diopters
[D]), moderate (-5.00 to -10.00 D), and high (greater than
-10.00 D). Visually significant myopia is considered to be
-1.00 D or greater. These specific stratifications are chosen
because they are most representative of those used in the
literature. In addition, the efficacy of different refractive
techniques varies with attempted correction. In general,
1
Chapter
photorefractive keratectomy (PRK) provides effective
results for patients with low myopia while laser in-situ ker-
atomileusis (LASIK) is effective for low and moderate
myopia. Phakic IOLs will likely address high myopia.
Prevalence
The distribution of levels of myopia is highly variable
among different races and ethnic groups. In general, the
prevalence of myopia tends to be higher among more
developed populations. The prevalence of myopia is esti-
mated to be 70% to 90% in Asia, 30% to 40% in Europe
and the Americas, and 10% to 20% in Africa.1 Among
individuals aged 12 to 54 in the United States, the preva-
lence of myopia is approximately 25%.2 Among individu-
als over age 40 in the United States, 30.5 million have
visually significant myopia.3 The most comprehensive,
population-based study of myopia in the United States
examined subjects ranging in ages from 4 to 74 years old
and found 43% with low, 3.2% with moderate, and 0.3%
with high myopia.4 Table 1-1 summarizes the relationship
between levels of myopia among individuals wearing cor-
rective lenses and age groups typically presenting for
refractive surgery.5 Myopia is more prevalent in younger
patients. More than three-fourths of those individuals aged
18 to 24 years that wear corrective lenses have low
myopia. Of patients presenting for myopic refractive sur-
gery, however, the numbers are skewed toward higher lev-
els of correction. McCarty et al compared the stratified
prevalence of myopia in the general population of
Melbourne, Australia with that of individuals presenting
for refractive surgery.3 The study found that while only
2 Chapter 1
Table 1-1
PREVALENCE OF LOW, MODERATE, AND HIGH MYOPIC SPHERICAL
EQUIVALENT AMONG INDIVIDUALS WEARING CORRECTIVE LENSES IN
AGE GROUPS TYPICALLY PRESENTING FOR REFRACTIVE SURGERY
Level of Myopia/Age 18 to 24
Low (-0.01 to -5.0 D) 77.0%
Moderate (-5.1 to -10.0 D) 7.2%
High (above -10.0 D) 0.8%
Adapted from Roberts J, Rowland M. Refraction Status and Motility Defects of Persons 4-74 Years, United States, 1971-1972. National
Center for Health Statistics. Vital Health Survey Series 11, Number 206. 1978.
* estimated
Figure 1-1. US refractive surgical procedures (adapted from
Market Scope. Refractive Market Perspectives [serial online].
2002;7(7). Available at: www.mktsc.com. Accessed June 12,
2003).
2% and 0.4% of the general population had moderate and
high myopia, respectively, 42% and 13% of those patients
presenting for refractive surgery had moderate and high
myopia, respectively (Table 1-2). In other words, moder-
ate myopes were ten times more likely to present for
refractive surgery than low myopes, and high myopes were
sixteen times more likely to present for refractive surgery
than low myopes. A similar result reported by Ucakhan et
al found that 17% of patients presenting for refractive sur-
gery at a center in the United States had myopia of -6.00
D or greater compared to an estimated 2% prevalence in
the general population.4
25 to 34 35 to 44 45 to 54
71.4% 62.0% 37.6%
5.8 % 4.6% 2.4%
0.4% 0.0% 0.0%
HYPEROPIA
Definitions
The following definitions will be used to stratify levels
of hyperopia: low (less than +3.00 D) and high (greater
than +3.00 D). Again, these stratifications are chosen
because they are most representative of those used in the
literature. In addition, the efficacy of different refractive
techniques varies with attempted correction. In general
PRK, LASIK, and conductive keratoplasty (CK) are effec-
tive for low hyperopia. Phakic IOLs will likely address
high hyperopia.
Prevalence
In the adult population, low hyperopia remains largely
silent clinically until the fifth decade due to the accom-
modative ability of the crystalline lens. In the United
States, there are 12 million cases of high hyperopia among
individuals over age 40.6 Table 1-3 summarizes the rela-
tionship between levels of hyperopia among individuals
wearing corrective lenses and age groups typically pre-
senting for refractive surgery, showing an increasing
prevalence of low hyperopia with age. The incidence of
high hyperopia does not appear to increase significantly
with advancing age. Presbyopic changes to the accom-
modative apparatus of the eye clearly play a role in caus-
ing hyperopic individuals to seek refractive surgical cor-
rections.
 Demographics of Refractive Surgery: The Role of Phakic Intraocular Lenses 3

Table 1-2

PREVALENCE
OF LOW, MODERATE, AND HIGH MYOPIA IN
NONCATARACTOUS GENERAL AND MYOPIC POPULATIONS AND THOSE
PRESENTING FOR MYOPIC REFRACTIVE SURGERY IN MELBOURNE, AUSTRALIA
Population Presenting
for Myopic Refractive
Level of Myopia General Population Myopic Population Surgery
Low (-0.01 to -5.0 D) 20% 88% 45%
Moderate (-5.1 to -10.0 D) 2% 10% 42%
High (above -10.0 D) 0.4% 2% 13%

Adapted from McCarty CA, Livingston PM, Taylor HR. Prevalence of myopia in adults: implications for refractive surgeons. J Refract
Surg. 1997;13:229-234.

Table 1-3

PREVALENCE OF LOW AND HIGH HYPEROPIC SPHERICAL

EQUIVALENT AMONG INDIVIDUALS WEARING CORRECTIVE LENSES
IN AGE G ROUPS T YPICALLY P RESENTING FOR R EFRACTIVE S URGERY

Level of Hyperopia/Age 18 to 24 25 to 34 35 to 44 45 to 54
Low (+0.01 to +3.0 D) 9.5% 15.2% 26.7% 50.1%
High (above +3.0 D) 3.3% 4.3% 3.0% 4.8%

Adapted from Refraction Status and Motility Defects of Persons 4-74 Years, United States, 1971-1972. National Health Survey Series
11, Number 206.

REFRACTIVE SURGICAL attempted correction in 1000 eyes treated at a single refrac-

PROCEDURES FOR MYOPIA
Refractive surgical procedures available to treat myopia
include LASIK, PRK, and its variants (laser subepithelial
keratectomy, otherwise known as LASEK or Epi-LASEK),
intracorneal ring segments, clear lens extraction, and pha-
kic IOL implantation.
Laser In-Situ Keratomileusis
There is little disagreement that LASIK affords the high-
est level of comfort, quickest recovery, and most stable, pre-
dictable outcome for low and moderate myopia.7,8 Efficacy
and predictability decrease, however, when treating high
myopia with LASIK.9,10 Table 1-4 reports the uncorrected
visual acuity 1 month following LASIK as a function of
tive center in the Midwest. The results demonstrate the sig-
nificant decrease in efficacy at the 20/25 level for correc-
tions above -8.00 D and at the 20/30 level for corrections
above -10.00 D. In addition to a decrease in efficacy, visual
function is more likely to be compromised with higher cor-
rections. The incidence of decreased contrast sensitivity and
increased glare and halos appears to be significantly higher
with large myopic corrections.11 This decrease in visual
function is likely related to alteration of the corneal
asphericity following myopic laser ablation in which the
natural prolate shape (ie, steep in the center, flat in the
periphery) of the anterior surface is converted to an oblate
shape (ie, flat in the center, steeper in the periphery).12
Oshika et al demonstrate a positive correlation between
amounts of induced coma-like and spherical-like aberrations
and increasing attempted correction.13 The study also
4 Chapter 1

Table 1-4

MEAN UNCORRECTED VISUAL ACUITY 1 MONTH AFTER

PRIMARY MYOPIC LASIK AS A FUNCTION OF ATTEMPTED CORRECTION
Myopic Correction (D) >20/20 >20/25 >20/30 >20/40
0 to 2 71% 91% 97% 100%
2 to 4 85% 93% 96% 100%
4 to 6 62% 98% 100% 100%
6 to 8 51% 71% 91% 100%
8 to 10 18% 27% 82% 100%
10 to 12 33% 33% 50% 83%

Adapted from analysis of 1000 eyes treated at Minnesota Eye Consultants, PA, Minneapolis, Minn.

shows a positive relation between eyes losing two or more
lines of best corrected acuity and level of induced coma-like
and spherical-like aberrations. Several studies report losses
of two or more lines of best-corrected visual acuity in 3% to
5% of highly myopic eyes treated with LASIK.9,14 Several
recent studies suggest best-corrected visual acuity may be
better with the Artisan (Ophtec BV, Groningen,
Netherlands) phakic IOL than LASIK in patients with high
myopia.15 A large study by Maloney et al reported 6 month
results on 84 eyes receiving the Artisan phakic IOL for
myopic correction ranging from -5.5 to -22.5 D (mean:
-13.0 D).16 At 6 months, 58% gained one or two lines of
best-corrected visual acuity. This is likely attributable to the
relative magnification achieved by elimination of spectacle
correction in high myopia17 and the preservation of natural
corneal asphericity.
Corneal thickness becomes a limiting factor with
increasing correction, as there appears to be a correlation
between risk of keratectasia and decreasing residual bed
thickness following LASIK.18-20 While the etiology of ker-
atectasia is not fully understood,21 it is generally accepted
that ablating below a minimum residual bed thickness
increases risk. The value of 250 ␮m has been proposed as a
threshold beyond which ablation should not proceed.22
Unfortunately, even this number may not be sufficient in
every case, as evidenced by reports of keratectasia following
shallow ablations with thicker residual beds.23 In some of
these cases, forme fruste keratoconus as seen on topography
may contribute to the development of keratectasia.24 In a
recent study by Hori-Komai et al examining the reasons
why patients presenting for refractive surgery did not under-
go LASIK or PRK, 25% of 2784 consecutive patients did
not undergo either procedure. Nearly 30% of the patients
that did not have surgery had either high myopia (>-12.00
D) or had insufficient corneal thickness.25 The concern over
adequate residual bed thickness, coupled with the lower
predictability of LASIK refractive outcomes at higher cor-
rections, leads to the additional issue of potential “nonen-
hanceability.” The high myope is more likely to require an
enhancement than the low or moderate myope but also may
not have enough tissue remaining to safely perform addi-
tional ablations. In these situations, a procedure that does
not remove corneal tissue and does not alter the natural pro-
late shape of the anterior corneal surface, such as phakic
IOL implantation, offers an attractive solution.
Photorefractive Keratectomy
PRK, which has been performed for more than a
decade, has proven extremely effective in treating low
myopia, demonstrating high levels of safety, efficacy, sta-
bility, and predictability.26-28 PRK holds particular appeal
for patients with corneas too thin for LASIK due to inade-
quate residual bed thickness. The absence of a flap typi-
cally adds 100 to 150 ␮m to the treatable stromal bed in
PRK. While LASIK became dominant in the late 1990s
due to its faster recovery and improved patient comfort,29
PRK has experienced a resurgence of interest recently due
to the introduction of wavefront-guided laser treatments30
and the notion that the microkeratome pass and flap heal-
ing in LASIK may introduce additional optical aberra-
tions.31,32 PRK, even more so than LASIK, however, per-
forms less impressively when treating moderate to high
myopia.33 The likelihood of significant regression of treat-
ment effect increases significantly with higher corrections,
possibly due to epithelial hyperplasia.34 In addition, stro-
mal wound healing can lead to subepithelial haze forma-
tion, with more severe haze developing with higher cor-
rections.35 The haze, which can decrease visual acuity
 Demographics of Refractive Surgery: The Role of Phakic Intraocular Lenses
directly in its more advanced manifestation, is thought to
closely relate to refractive regression.36 These two fac-
tors—regression and subepithelial haze—dramatically
reduce PRK efficacy in treating high myopia. One study
found efficacy of only 30% for achieving 20/40 or better
and 4% for 20/20 or better uncorrected acuity at 6 months
in the high myope.37
Issues describing decreased visual function resulting
from induced higher-order aberrations, which were dis-
cussed in the LASIK section, apply to high myopia PRK
treatments as well. However, with the lack of a flap, PRK
may introduce fewer aberrations if the healing process can
be adequately controlled when treating large corrections.
In particular, the use of mitomycin C (MMC) may be
advantageous to reduce subepithelial haze formation in
moderate and high myopic treatments using PRK.38,39 A
recent prospective, randomized study compared the
6-month uncorrected visual acuity (UCVA) between eyes
with moderate myopia treated with and without MMC. A
statistically significant difference was found in UCVA at
6 months at both the 20/20 or better level (60% of the
MMC group vs 30% of the control group) and the 20/40
or better level (100% of the MMC group vs 83% of the
control group).40
LASEK or Epi-LASEK, which is a variant of PRK, cre-
ates an “epithelial flap” that is then repositioned after laser
ablation in an attempt to improve the time course and out-
come of the wound healing response. Recent studies sug-
gest results are similar to those found with LASIK or PRK
in treating low myopia.41-43 Some studies suggest that
there may be some advantage to LASEK over PRK in treat-
ing moderate myopia due to a lower incidence of subep-
ithelial haze44; however, this is controversial.
Intracorneal Ring Segments
Intracorneal ring segments (ICRs) address low myopia,
typically correcting -3.50 D or less. A unique feature of
ICRs is the ability to reverse or change the refractive effect
by segment explantation or exchange.45 Efficacy, pre-
dictability, and visual function outcomes of ICRs are com-
parable to LASIK and PRK.46,47 There are conflicting
reports, however, regarding a diurnal variation of refractive
correction using ICRs. Some suggest that there is a myopic
shift in the evening similar to that seen in post-radial kera-
totomy eyes, particularly in the early postoperative peri-
od.48,49 The surgical technique does not involve the central
cornea, and it preserves the prolate shape internal to the
ring segments. The narrow range of myopia for which
intracorneal rings are effective, the limited sizes available
within the range of correction, and the inability of this
technology to deal with astigmatism, coupled with the
tremendous success of LASIK and PRK in treating low
myopia, have limited the use of this technology. A new
application, however, is revitalizing interest in the tech-
5
nique. Several recent studies indicate ICRs may be effective
in reducing the corneal steepening and astigmatism associ-
ated with keratoconus and iatrogenic keratectasia following
refractive surgery, thereby improving uncorrected and
best-corrected visual acuity as well as contact lens fit, thus
delaying the need for penetrating keratoplasty.50-53
Refractive Lens Exchange
Refractive lens exchange, or clear lens extraction,
involves removal of the crystalline lens in a highly
ametropic eye using a standard phacoemulsification tech-
nique followed by placement of a posterior chamber IOL.
Interest in this technique has increased in recent years due
to several factors:
1. Improvement in cataract extraction techniques using
phacoemulsification, which provides a safer, less
traumatic method for lens removal over previous
extracapsular and intracapsular techniques
2. Advancements in posterior IOL designs, including
the availability of low positive and negative power,
foldable lenses54
3. Suboptimal efficacy and safety of corneal refractive
procedures in the highly myopic or hyperopic eye
In addition, IOL surgery offers the potential for
improved best-corrected vision by preserving corneal
asphericity and providing relative magnification achieved
with elimination of spectacle correction in high
myopia.55,56 One significant concern with this technique
is the risk of retinal detachment. This vision-threatening
complication had a relatively high risk during the prepha-
coemulsification era, as high as 7% according to one large
retrospective study.57 More recent studies provide con-
flicting evidence regarding the incidence of retinal detach-
ment in patients following clear lens extraction using pha-
coemulsification. A study by Colin et al reports an 8%
incidence of retinal detachment over a 7-year postopera-
tive period in a series of 52 eyes.58 Other studies, howev-
er, indicate that the incidence may be significantly lower,
especially following meticulous identification and prophy-
lactic treatment of retinal pathology prior to surgery.56,59
There is insufficient evidence, however, to support 360-
degree prophylactic photocoagulation in these patients.
Ripandelli et al reported on 41 eyes that sustained retinal
detachments following clear lens extraction (mean preop-
erative refraction = -19.5 D).60 Sixty-three percent of
these eyes had 360-degree prophylactic photocoagula-
tion.60 Another concern is decreased accuracy of IOL
power calculation in high axial myopia and the potential
for a postsurgical refractive surprise that may require addi-
tional surgery. The availability of multifocal IOLs allows
surgeons to address both distance and near vision using
clear lens extraction.61,62 The loss of natural accommoda-
tion, however, is likely unacceptable to the young patient
6 Chapter 1
who is considering refractive surgery for high myopia.
Phakic IOL technology, which addresses high myopia and
preserves accommodation, may provide a more effective
refractive surgical solution for young patients with high
myopia.
Myopic Refractive Surgery:
Current Practice Patterns
A 2001 survey of 188 US members of the International
Society of Refractive Surgery (ISRS) highlights the current
trends among refractive surgeons in choosing among the
various techniques for correction of a given refractive
error.63 Ninety-five percent of surgeons would choose
LASIK to treat a 30-year-old -3.00 D myope and 98%
would choose LASIK to treat a 30-year-old -7.00 D
myope. Fifty-three percent would treat a -12.00 D myope
with LASIK, 26% would use a phakic IOL, and 10% would
wait for a better surgical alternative. This survey was con-
ducted in 2001, prior to US Food and Drug
Administration (FDA) approval of any phakic IOL devices
in the United States.
REFRACTIVE SURGICAL
PROCEDURES FOR HYPEROPIA
Refractive surgical procedures available to treat hyper-
opia include LASIK, PRK and its variants, thermal kerato-
plasty (CK and laser thermokeratoplasty [LTK]), clear
lens extraction, and phakic IOL implantation.
Laser In-Situ Keratomileusis
Hyperopic excimer laser techniques steepen the cornea
by removing tissue differentially from the midperipheral
cornea. Centration and the ability to treat larger optical
zones are crucial factors. With the introduction of micro-
keratomes capable of cutting larger diameter flaps and
scanning or “flying” spot lasers capable of larger optical
zones equipped with active eye trackers that significantly
improve optical zone alignment, the clinical results of
LASIK for hyperopia have improved significantly.64,65
Table 1-5, comparing the results from the most recent
studies on CK, PRK (see the next section), and LASIK for
the treatment of low hyperopia, shows better than 90%
efficacy for achieving 20/40 or better uncorrected acuity
with all techniques. Recent investigations identify a
threshold of hyperopic correction, above which pre-
dictability and efficacy of LASIK decreases. Cobo-Soriano
et al identified a threshold of +3.00 D above which signif-
icant regression occurs, +4.00 D above which a significant
decrease in predictability occurs, and + 6.00 D above
which a significant decrease in safety occurs.66
Photorefractive Keratectomy
Early studies of PRK for treating hyperopia described
poor predictability and efficacy for high corrections and a
high sensitivity to optical zone decentration.67-69 A sig-
nificant myopic shift or overcorrection was also noted,
probably related to less predictable nomograms and small
optical zones available with the broad-beam, erodible
mask techniques used at that time. A large study of 482
eyes by Nagy et al reported UCVA 20/40 or better in
88.4% of patients at 12 months.70 Refractive stability was
not achieved, however, as regression still occurred at 12
months.71 PRK, like LASIK, has benefited from recent
technological improvements, providing larger flaps,
expanded optical zones, and eye tracking systems. The
most recent PRK studies have looked at treating low
hyperopia with the latest laser technology, including one
study using wavefront-driven ablation. These studies by
Nagy et al72,73 are summarized in Table 1-5 along with
LASIK and CK data for comparison. The results suggest
hyperopic PRK and LASIK using the latest excimer laser
technology may offer somewhat improved stability in
treating low hyperopia when compared to CK. Studies
examining PRK using the latest laser technology to treat
high hyperopia have yet to be published.
Conductive Keratoplasty
The application of thermal energy to the corneal stro-
ma to affect a change in curvature is known as thermal ker-
atoplasty. This technique has been developed clinically to
treat low hyperopia by steepening the corneal curvature.
Unlike excimer laser ablative procedures, such as PRK and
LASIK, the technique has the advantage of sparing the
visual axis from surgical manipulation and preserving,
rather than removing or ablating, corneal tissue. The CK
technique, originally developed by Mendez et al,74 uses
the electrical conductive and resistive properties of the
cornea, rather than its thermal properties, to propagate
energy through the stroma. The resistance of the stroma to
current flow creates heat, causing collagen shrinkage. By
applying spots in a circumferential pattern in the midpe-
riphery, the collagen shrinkage causes central steepening,
inducing the desired myopic shift. The technique current-
ly treats hyperopia up to +3.00 D. Table 1-5 summarizes
results from the FDA trial for CK75 and compares these
results with studies on LASIK and PRK for the treatment
of low hyperopia. While efficacy is comparable, LASIK
and PRK appear to afford a higher level of stability than
CK. LTK makes use of laser energy instead of radiofre-
quency energy to heat the stroma. LTK has been largely
replaced by CK due to an unacceptable regression profile
with LTK.
 Demographics of Refractive Surgery: The Role of Phakic Intraocular Lenses 7

Table 1-5

COMPARISON OF CLINICAL DATA FROM STUDIES EXAMINING

CK, PRK, WAVEFRONT PRK, AND LASIK TO TREAT HYPEROPIA
Paper McDonald75 Nagy72 Nagy73 Salz65
Instrument (Technique) Viewpoint Meditec MEL 70 Meditec MEL 70
LADARVision
(CK) (PRK) (wavefront PRK)
(LASIK)
Mean age 55 39 38 53‡
Mean preoperative MRSE (D) +1.80 +2.48 +2.90 NA†
Preoperative MRSE range (D) +0.75 to +3.00 +1.00 to +3.50 +1.00 to +4.00
+0.88 to
+2.90†
Follow-up (number of eyes) 12 months 12 months 6 months 12 months
(344) (62) (40) (88†)
UCVA >20/20 56% 89% 70% 55%†
UCVA >20/40 92% 97% 90% 96%†
SE within ± 0.50 D 62% 82% 85% 78%†
SE within ± 1.00 D 89% 94% 100% 93%†
Two line loss of BCVA 2% 2% 13% 5%†
>1.0 D induced cylinder 5% NA NA 8%*
>2.0 D induced cylinder 0.3% NA NA 1%
Mean SE regression +0.23 D +0.00 D -0.25 D +0.05 D
(6 to 12 m) (6 to 12 m) (3 to 6 m) (6 to 12 m)*
MRSE = mean refractive spherical equivalent; SE = spherical equivalent; UCVA = uncorrected visual acu-
ity; BCVA = best-corrected visual acuity
*For large spherical hyperopia cohort (mean SE = +2.68, range = +1.00 to +6.00 D)
‡For entire study cohort including spherical hyperopes, hyperopic astigmats, and mixed astigmats
†For low spherical hyperopia subcohort that most closely matches CK study

Note: The efficacy, predictability, and safety results are comparable with somewhat higher efficacy at the
20/20 level with PRK. The most significant difference occurs in the regression data in which LASIK and PRK
appear to have better stability than CK, especially considering the LASIK data include corrections up to
+6.00 D.

Refractive Lens Exchange excluding nanophthalmic eyes. Recent studies indicate

Most studies investigating refractive lens exchange for
the treatment of hyperopia do not examine patients
younger than ages 35 to 40, primarily because clinically
significant hyperopia is rare below the prepresbyopic age,
with the exception of hyperopic children with strabismus
and/or amblyopia. The risk of retinal detachment is signif-
icantly lower among hyperopes than high myopes. This
fact, coupled with the greatly reduced accommodative
amplitudes of presbyopic individuals, makes clear lens
extraction a much more attractive option for the treatment
of high hyperopia than for the treatment of high myopia,
good efficacy and predictability in treating high hyperopia
with this technique.76,77 The development of posterior
capsular opacity appears to be higher than that of conven-
tional cataract extraction, as high as 54% in one study.76
This may be due to the more vigorous inflammatory
response seen in younger patients. One of the difficulties
of clear lens extraction is that high refractive power IOLs
are required to achieve emmetropia. Even though IOL
manufacturers make higher power lenses, the lens thick-
ness often makes foldable insertion impossible. As a result,
several investigators advocate piggyback lens insertion for
8 Chapter 1
high hyperopic clear lens extraction.78,79 Additionally,
IOL power calculations are relatively inaccurate in high
hyperopic eyes. The Holladay II formula appears to pro-
vide improved accuracy in this population.80
Hyperopic Refractive Surgery:
Current Practice Patterns
The 2001 ISRS survey of US refractive surgeons63 found
that 70% would choose LASIK to treat a 45-year-old +1.00
D hyperope while 17% would choose CK/LTK. Eighty-
four percent would choose LASIK to treat a +3.00 D
hyperope. Only 29% would use LASIK to treat a +5.00 D
hyperope while 39% would choose clear lens extraction
and 30% would wait for a better surgical alternative. The
survey was conducted in 2001 prior to US FDA approval of
any phakic IOL devices and, in fact, did not include phakic
IOLs as a surgical option for treatment of hyperopia.
SUMMARY
Excimer laser procedures afford the most effective
treatment for low and moderate myopia and low hyper-
opia. Conductive keratoplasty is also effective in treating
low hyperopia. The advantages of phakic IOLs over other
refractive surgical techniques are significant for highly
ametropic eyes. Efficacy, predictability, and safety of
excimer laser procedures in the treatment of high myopia
are suboptimal. The maintenance of natural corneal pro-
late asphericity and resultant preservation of contrast sen-
sitivity and visual function represents a significant advan-
tage over techniques that remove and/or reshape corneal
tissue (eg, excimer laser and thermal keratoplasty tech-
niques). This advantage may also allow for improvements
in best-corrected visual acuity not available with other ker-
atorefractive techniques. The preservation of accommoda-
tion is a distinct advantage of phakic IOLs over clear lens
extraction. The ability to avoid the violation of the crys-
talline lens/capsule complex and the minimal mechanical
trauma associated with the phakic IOL surgical technique
may offer additional advantages over clear lens extraction
by preventing vitreoretinal complications in the highly
myopic eye. Astigmatism in these patients may be
addressed through “bioptics”81-83 (LASIK flap + phakic
IOL implantation + laser ablation to correct residual
ametropia) and/or toric phakic IOLs. See Chapter 18 for a
discussion of bioptics and Chapter 21 for a discussion of
toric phakic IOLs.84
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41. Anderson NJ, Beran RF, Schneider TL. Epi-LASEK for the
correction of myopia and myopic astigmatism. J Cataract
Refract Surg. 2002;28:1343-1347.
42. Litwak S, Zadok D, Garcia-de Quevedo V, et al. Laser-
assisted subepithelial keratectomy versus photorefractive
keratectomy for the correction of myopia. A prospective
comparative study. J Cataract Refract Surg. 2002;28:1330-
1333.
43. Shahinian L. Laser-assisted subepithelial keratectomy for
low to high myopia and astigmatism. J Cataract Refract
Surg. 2002;28:1334-1342.
44. Claringbold TV. Laser assisted subepithelial keratectomy
for the correction of myopia. J Cataract Refract Surg.
2002;28:18-22.
45. Asbell PA, Ucakhan OO, Durrie DS, Lindstrom RL.
Adjustability of refractive effect for corneal ring segments.
J Refract Surg. 1999;15:627-631.
46. Suiter BG, Twa MD, Ruckhofer J, Schanzlin DJ. A compar-
ison of visual acuity, predictability, and visual function out-
comes after intracorneal ring segments and laser in situ ker-
atomileusis. Trans Am Ophthalmol Soc. 2000;98:51-55.
47. Cochener B, Le Floch-Savary G, Colin J, et al. Excimer pho-
torefractive keratectomy (PRK) versus intrastromal corneal
ring segments (ICRS) for correction of low myopia. J Fr
Ophthalmol. 2000;23:663-678.
48. Twa MD, Hurst TJ, Walker JG, et al. Diurnal stability of
refraction after implantation with intracorneal ring seg-
ments. J Cataract Refract Surg. 2000;26:516-523.
10 Chapter 1
49. Baïkoff G, Maia N, Poulhalec D, et al. Diurnal variations in
keratometry and refraction with intracorneal ring segments.
J Cataract Refract Surg. 1999;25:1056-1061.
50. Colin J, Cochener B, Savary G, Malet F. Correcting kerato-
conus with intracorneal rings. J Cataract Refract Surg.
2000;26:1117-1122.
51. Siganos CS, Kymionis GD, Kartakis N, et al. Management
of keratoconus with Intacs. Am J Ophthalmol. 2003;135:64-
70.
52. Lovisolo CF, Fleming JF. Intracorneal ring segments for
iatrogenic keratectasia after laser in situ keratomileusis or
photorefractive keratectomy. J Refract Surg. 2002;18:535-
541.
53. Alio J, Salem T, Artola A, Osman A. Intracorneal rings to
correct corneal ectasia after laser in situ keratomileusis.
J Cataract Refract Surg. 2002;28(9):1568-1574.
54. Jimenez-Alfaro I, Miguelez S, Bueno JL, Puy P. Clear lens
extraction and implantation of negative-power posterior
chamber intraocular lenses to correct extreme myopia.
J Cataract Refract Surg. 1998;24:1310-1316.
55. Wang J, Shi Y. Clear lens extraction with phacoemulsifica-
tion and posterior chamber intraocular lens implantation for
treatment of high myopia. Chung Hua Yen Ko Tsa Chih.
2001;37:350-354.
56. Pucci V, Morselli S, Romanelli F, et al. Clear lens pha-
coemulsification for correction of high myopia. J Cataract
Refract Surg. 2001;27:896-900.
57. Barraquer C, Cavalier C, Majia LF. Incidence of retinal
detachment following clear-lens extraction in myopic
patients; retrospective analysis. Arch Ophthalmol.
1994;112:336-339.
58. Colin J, Robinet A, Cochener B. Retinal detachment after
clear lens extraction for high myopia: seven-year follow-up.
Ophthalmology. 1999;106:2281-2284.
59. Fan DS, Lam DS, Li KK. Retinal complications after
cataract extraction in patients with high myopia.
Ophthalmology. 1999;106:688-691.
60. Ripandelli G, Billi B, Fedeli R, Stirpe M. Retinal detachment
after clear lens extraction in 41 eyes with high axial myopia.
Retina. 1997;17:78-79.
61. Fine IH, Hoffman RS, Packer M. Clear-lens extraction with
multifocal lens implantation. Int Ophthalmol Clin.
2001;41:113-121.
62. Dick HB, Gross S, Tehrani M, et al. Refractive lens
exchange with an array multifocal intraocular lens. J Refract
Surg. 2002;18:509-518.
63. Duffey RJ, Leaming D. US trends in refractive surgery: 2001
International Society of Refractive Surgery Survey. J Refract
Surg. 2002;18:185-188.
64. Reviglio VE, Bossana EL, Luna JD, et al. Laser in situ ker-
atomileusis for myopia and hyperopia using the Lasersight
200 laser in 300 consecutive eyes. J Refract Surg.
2000;16:716-723.
65. Salz JJ, Stevens CA. LASIK correction of spherical hyper-
opia, hyperopic astigmatism, and mixed astigmatism with
the LADARVision excimer laser system. Ophthalmology.
2002;109:1647-1656.
66. Cobo-Soriano R, Llovet F, Gonzalez-Lopez F, et al. Factors
that influence outcomes of hyperopic laser in situ ker-
atomileusis. J Cataract Refract Surg. 2002;28:1530-1538.
67. Dausch DG, Klein RJ, Schroder E, et al. Photorefractive
keratectomy for hyperopic and mixed astigmatism. J Refract
Surg. 1996;12:684-692.
68. Pietila J, Makinen P, Pajari S, et al. Excimer laser photore-
fractive keratectomy for hyperopia. J Refract Surg. 1997;13:
504-510.
69. Vinciguerra P, Epstein D, Radice P, et al. Long-term results
of photorefractive keratectomy for hyperopia and hyperop-
ic astigmatism. J Refract Surg. 1998;14:S183-S185.
70. Jackson WB, Casson E, Hodge WG, et al. Laser vision cor-
rection for low hyperopia. An 18-month assessment of safe-
ty and efficacy. Ophthalmology. 1998;105:1727-1738.
71. Nagy ZZ, Krueger RR, Hamberg-Nystrom H, et al.
Photorefractive keratectomy for hyperopia in 800 eyes with
the Meditec MEL 60 laser. J Refract Surg. 2001;17:525-533.
72. Nagy ZZ, Munkacsy G, Popper M. Photorefractive kerate-
ctomy using the meditec MEL 70 G-scan laser for hyperopia
and hyperopic astigmatism. J Refract Surg. 2002;18:542-
550.
73. Nagy ZZ, Palagyi-Deak I, Kovacs A, et al. First results with
wavefront-guided photorefractive keratectomy for hyper-
opia. J Refract Surg. 2002;18:S620-S623.
74. Mendez A, Mendez Noble A. Conductive keratoplasty for
the correction of hyperopia. In: Sher N, ed. Surgery for
Hyperopia and Presbyopia. Philadelphia, Pa: Williams and
Wilkins; 1997:163-171.
75. McDonald MB, Hersh PS, Manche EE, et al. Conductive
keratoplasty for the correction of low to moderate hyper-
opia: U.S. clinical trial 1-year results on 355 eyes.
Ophthalmology. 2002;109:1978-1989.
76. Siganos DS, Pallikaris IG. Clear lensectomy and intraocular
lens implantation for hyperopia from +7 and +14 diopters.
J Refract Surg. 1998;14:105-113.
77. Kolahdouz-Isfahani AH, Rostamian K, Wallace D, Salz JJ.
Clear lens extraction with intraocular lens implantation for
hyperopia. J Refract Surg. 1999;15:316-323.
78. Holladay JT, Gills JP, Leidlein J, Cherchio M. Achieving
emmetropia in extremely short eyes with two piggy-back
posterior chamber lenses. Ophthalmology. 1996;103:1118-
1124.
79. Donoso R, Rodriguez A. Piggyback implantation using the
AMO array multifocal intraocular lens. J Cataract Refract
Surg. 2001;27:1506-1510.
80. Fenzl RE, Gills JP, Cherchio M. Refractive and visual out-
come of hyperopic cataract cases operated on before and
after implementation of the Holladay II formula.
Ophthalmology. 1998;105:1759-1764.
 Demographics of Refractive Surgery: The Role of Phakic Intraocular Lenses 11

81. Zaldivar R, Davidorf JM, Oscherow S, et al. Combined pos-
terior chamber phakic intraocular lens and laser in situ ker-
atomileusis: bioptics for extreme myopia. J Refract Surg.
1999;15:299-308.
82. Velarde JI, Anton PG, de Valentin-Gamazo L. Intraocular
lens implantation and laser in situ keratomileusis (bioptics)
to correct high myopia and hyperopia with astigmatism.
J Refract Surg. 2001;17(2 Suppl):S234-S237.
83. Zaldivar R, Oscherow S, Piezzi V. Bioptics in phakic and
pseudophakic intraocular lens with the Nidek EC-5000
excimer laser. J Refract Surg. 2002;18(3 Suppl):S336-S339.
84. Dick HB, Alio J, Bianchetti M, et al. Toric phakic intraocu-
lar lens: European multicenter study. Ophthalmology.
2003;110:150-162.

The History of
Phakic Intraocular Lenses
Patricia Sierra Wilkinson, MD and David R. Hardten, MD, FACS
Since the end of the 19th century, various methods to
correct high myopia have been developed. In 1890, Fukala
proposed and performed the extraction of the clear crys-
talline lens for the correction of high myopia.1 However,
toward the end of the century, increasing evidence that
retinal detachment was a complication of this operation
lead to rigid indications and decreased acceptance by sur-
geons.
In the 1950s, surgeons developed intraocular lenses
(IOLs) to correct aphakia. Credit for the invention and
first implantation of an IOL is given to Sir Harold Ridley
of London (Figure 2-1A).2 His first implant was a biconvex
disc designed for implantation in the posterior chamber
(PC) after an extracapsular cataract extraction (ECCE)
procedure (Figures 2-1B and 2-1C). The first permanent
implantation was performed on February 8, 1950 as a two-
step procedure, a few months after the patient had under-
gone an ECCE. From his very first cases, Sir Ridley
encountered two major problems: IOL malposition and
posterior capsule opacification (PCO). The main reasons
for the decentration were the excessive weight of the
implant, inappropriate fixation haptics, and irregular and
insufficient anterior capsule. Despite awareness of the eti-
ology of the development of PCO, limitations in the
removal of cortex with the available techniques limited the
resolution of this complication.3
In order to circumvent the two mentioned complica-
tions, there was a movement toward a second generation
of IOLs, the early anterior chamber (AC) IOLs, which
were implanted after intracapsular cataract extraction
(ICCE) (Figure 2-1D). During this period of time, some
2
Chapter
surgeons began placing minus power AC IOLs in phakic
eyes to correct myopia. Benedetto Strampelli was the first
surgeon to report this in 1953.4 The Strampelli lens had a
radius of curvature of 13 mm but was thick and rigid
(Figure 2-2). It was implanted in the AC using the irido-
corneal angle for support. Complications due to the inabil-
ity to match the anterior chamber diameter and lens
length resulted in excessive lens movement with subse-
quent endothelial cell damage, corneal decompensation,
iritis, and pupillary and peripheral iridectomy block.5 To
avoid this pupillary block, an improved model was
designed by Cogan and Boberg-Ans (Figure 2-3)5; howev-
er, complications still occurred.
Other lenses were later developed in an attempt to
decrease these complications, such as the Dannheim lens
(Figure 2-4),5 which solved the problems of thickness,
weight, and elasticity inherent in the Strampelli lens.
However, it was still hard to match the lens length with
the AC diameter, and unfortunately, the same problems
remained.
In 1959, Joaquin Barraquer optimistically reported 239
implantations in phakic myopic eyes. The chief difference
in the Barraquer lens (Figure 2-5) was that its support was
curved and the haptics were more elastic, providing a bet-
ter fit into the AC.5 Unfortunately, many of the lenses
implanted by Barraquer had to be removed because of sim-
ilar complications, including corneal edema, chronic irido-
cyclitis, and hyphema.6 Peter Choyce in 19647 started to
use implants with thinner haptics and reported a signifi-
cant decrease in corneal dystrophies and other complica-
tions.
14 Chapter 2

Figure 2-1A. Sir Harold Ridley

of London, 1990 (reprinted
with permission from Apple
D, Auffarth G, Peng Q,
Vissessook N. Foldable
Intraocular Lenses: Evolution,
Clinicopathologic
Correlations, and Compli-
cations. Thorofare, NJ: SLACK
Incorporated; 2002).

Figure 2-1B. Ridley's original posterior chamber lens (reprinted

with permission from Apple D, Auffarth G, Peng Q, Vissessook
N. Foldable Intraocular Lenses: Evolution, Clinicopathologic
Correlations, and Complications. Thorofare, NJ: SLACK
Incorporated; 2002).

Figure 2-1C. Position of the Ridley lens in the

posterior chamber (reprinted with permission
from Apple D, Auffarth G, Peng Q, Vissessook
N. Foldable Intraocular Lenses: Evolution, Clin-
icopathologic Correlations, and Complications.
Thorofare, NJ: SLACK Incorporated; 2002).
Figure 2-1D. Movement to anterior chamber
intraocular lenses. Notice the close proximi-
ty of the lens to the corneal endothelium
(reprinted with permission from Apple D,
Auffarth G, Peng Q, Vissessook N. Foldable
Intraocular Lenses: Evolution, Clinicopatho-
logic Correlations, and Complications. Thoro-
fare, NJ: SLACK Incorporated; 2002).

Figure 2-2. Strampelli lens (reprinted with permission from

Barraquer J. Anterior chamber plastic lenses. Results of and con-
clusions from a five years' experience. Ophthalmol Soc UK.
1959;79:393-424).

Figure 2-3. Cogan Boberg-Ans fenestrated lens (reprinted with

permission from Barraquer J. Anterior chamber plastic lenses.
Results of and conclusions from a five years' experience.
Ophthalmol Soc UK. 1959;79:393-424).

Figure 2-4. The Dannheim lens (reprinted with permission from
Barraquer J. Anterior chamber plastic lenses. Results of and con-
clusions from a five years' experience. Ophthalmol Soc UK.
1959;79:393-424).
Despite the improvements, the use of negative power
phakic IOL implantation for high myopia correction was
abandoned for two reasons8: faulty lens design (solid lens-
es with thick periphery) and faulty surgical technique.
There was no concept of endothelial vitality, no viscoelas-
tic substances used to form the AC, no miotics used in
many cases, and no effort to avoid traumatizing the natu-
ral crystalline lens.
Drews later reviewed some of Barraquer’s explanted
lenses, which had been preserved by an operating room
nurse in Barcelona. He found the lenses were coarse and of
poor quality, with 1-mm thick haptics that were poorly
polished.9
Thus, the concept of IOLs in the phakic eye was
deemed unsuccessful. The US Food and Drug
Administration (FDA) and the ophthalmic profession had,
in general, assumed a negative posture on phakic IOLs and
they were condemned as being untenable and abandoned
for almost the latter third of the twentieth century.
Over the years, the AC lenses underwent a remarkable
change. The haptics became thinner and more flexible and
the surfaces of the lenses more polished. Surgical tech-
niques had improved markedly due to the advent of micro-
surgery and the invention of viscoelastic substances. As a
result, the concept of minus-power IOL implantation in
phakic myopes was revived in the 1980s with the emer-
gence of new lens styles implanted in informal clinical tri-
als. Four ophthalmic surgeons were prominent in the
revival of interest in phakic IOLs: Fechner of Germany,
who in 1986 suggested new designs for phakic IOLs based
on the lens of Worst of the Netherlands, whose iris-claw
lens had been used for the correction of aphakia and was
modified to correct myopia; Baïkoff of France, who modi-
fied the four-point, angle fixation, multiflex AC lens to
The History of Phakic Intraocular Lenses 15
Figure 2-5. The Barraquer lens (reprinted with permission from
Barraquer J. Anterior chamber plastic lenses. Results of and con-
clusions from a five years' experience. Ophthalmol Soc UK.
1959;79:393-424).
correct myopia; and Fyodorov of Russia, who introduced a
plate-style IOL for insertion in the PC with fixation in the
ciliary sulcus.
In 1986, Dvali reported the use of AC angle supported
lenses to correct myopia in phakic eyes.10 In that same
year, Baïkoff presented his new angle-supported AC IOL
to correct high myopia in phakic eyes. It was derived from
the Kelman-type implant to correct aphakia.11 The lens
was a multiflex style, angle supported, one-piece, poly-
methylmethacrylate (PMMA) lens. It had a solid haptic
with four-point contact in the angle and a prominent ante-
rior vault with a concave optic. This first model with angu-
lar support was the ZB implant (Figure 2-6). In 1988,
Baïkoff and Joly presented the first results obtained after
the implant of the ZB lens for the correction of high
myopia. Optical quality was excellent, precision very
good, and correction stable over time. Nevertheless,
severe endothelial loss appeared in the first 2 years12,13
and clinical investigation was suspended.
Worst and Fechner14-16 doubted whether the AC angle
was the correct place for the fixation of an artificial lens
and decided to adopt a different approach. Based on the
historical corneal decompensation associated with pupil-
lary fixated aphakic IOLs, they chose a peripheral iris-claw
haptic carrier based on the Worst design in 197717 (Figure
2-7A) and constructed the Worst-Fechner biconcave
myopia lens in 1986 (Figure 2-7B).16 By incarceration of
the midperiphery of the iris into the haptic, the PMMA
lens is kept suspended in front of the pupil. Earlier pupil-
lary fixated pseudophakic lenses were associated with
uveal inflammation, cystoid macular edema, pupillary
membrane formation, and corneal decompensation due to
endothelial cell trauma caused by the contact between the
endothelium and the edge of theses lenses.3 In contrast,
16 Chapter 2

A B
Figure 2-6. The Baïkoff first generation lens (reprinted with permission from Baïkoff G, Joly P. Comparison of minus power anterior
chamber intraocular lenses and myopic epikeratoplasty in phakic eyes. Refract Corneal Surg. 1990;6:252).

Figure 2-7A. Iris-claw lens, standard model (reprinted with per- Figure 2-7B. Worst-Fechner biconcave lens (reprinted with per-
mission from Alpor JJ, Fechner PU. Intraocular lenses. In: mission from Fechner PU, Strobel J, Wiechmann W. Correction
Intraocular Lenses. New York: Thieme; 1986:328-335). of myopia by implantation of a concave Worst iris-claw lens into
phakic eyes. Refract Corneal Surg. 1991;7(4):286-298).

the Worst-Fechner lenses were attached to the peripheral

iris, which is relatively immobile and provides a more sta-
ble anchor than the pupillary margin. In addition, the lens-
iris diaphragm is intact in the phakic eye so that the vitre-
ous does not propel movements of the lens.
In November 1986, Fechner implanted the first minus
power iris-claw lenses into two highly myopic phakic eyes
of one patient. The original biconcave IOL (made by
Ophtec BV, Groningen, Netherlands) of PMMA was con-
cave on the side facing the crystalline lens to provide
space for the latters convexity. The anterior surface was
also concave, thus contributing to the total refractive
power.18 In 1991, after the end of series implantations,
Ophtec changed the IOL design to a convex-concave
model, which is now the only model available (Figures 2-
8A and 2-8B) (trade name in the United States is Artisan
phakic IOL [Ophtec BV, Groningen, Netherlands]).18,19
Because Baïkoff’s angle-supported ZB lens initial failure
related to endothelial damage was presumed to be due to
excessive contact between the lens and the endothelium,
the ZB model was redesigned as the Chiron/Domilens
Model ZB 5M. The optic was moved backward, away from
the corneal endothelium, and provided with a more flexi-
ble loop as well as a reduced optic thickness (Figure 2-9).
However, despite the improvements and decreased inci-
dence of complications, including endothelial decompen-
sation, pupillary ovalization and halos/glare were report-
ed.20 As a result of the latter complications, further modi-
fications were made to create a third generation of
Baïkoff’s AC IOL. The Bausch & Lomb Surgical/Chiron
Vision Model NuVita MA20 (Figure 2-10) offered a
redesigned optic, loop, and footplate to eliminate refract-
ed glare; an arched shape; and a more convex anterior face
 The History of Phakic Intraocular Lenses 17

Figure 2-8A. Artisan lens (courtesy of Ophtec BV).

Figure 2-8B. Artisan lens in a myopic eye (courtesy of Ophtec BV).

A B
Figure 2-9. Comparison between the first- and second-generation Baïkoff's angle-supported phakic intraocular lenses. A. ZB: first
generation. B. ZB 5M: second generation. Notice the reduction of the vaulting and thinner optic (reprinted with permission from
Baïkoff G. Intraocular phakic implants in the anterior chamber. Int Ophthalmol Clin. 2000;40(3):223-235).

The original idea of moving toward the PC surged in

Figure 2-10. Baïkoff's third-generation lens: the NuVita Lens
(reprinted with permission from Baïkoff G. Intraocular phakic
implants in the anterior chamber. Int Ophthalmol Clin.
2000;40(3):223-235).
in order to decrease the peripheral rubbing of the lens
against the iris, which was attributed as the main cause of
pupillary ovalization. Finally, after undergoing all of these
changes, satisfactory results were obtained.20,21
1986 after the Russian surgeon Svyatoslov Fyodorov
designed a silicone PC phakic IOL made of one-piece sil-
icone collar button with a 500 to 600 nm Teflon coat capa-
ble of fitting in the PC in an attempt to correct high
myopia in phakic patients (Figure 2-11).22,23 Problems
with cataract formation and uveitis lead to multiple refine-
ments in lens design and use of more biocompatible mate-
rials. The original implant served eventually as the basis
for STAAR’s intraocular contact lens, commonly known
today as the Implantable Contact Lens (ICL) (STAAR
Surgical AG, Monrovia, Calif). The first ICL surgery was
performed in Italy. At that time, the ICL was similar to a
plate-haptic lens and the design was called “soap-bar.”24
Users of the ICL modified the design because the vaulting
was not sufficient to create an acceptable space between
the ICL and the crystalline lens. Complications, such as
pupillary block, postimplantation secondary cataract, and
pigment dispersion, have been described.25 The V2, V3,
and V4 models were successively developed in order to
improve the design and decrease complications. Initially,
the V1 model had the same dimension for the optic diam-
18 Chapter 2
Figure 2-11. Fyodorov lens (reprinted with permission from Kaya
V, Kevser MA, Yilmaz ÖF. Phakic posterior chamber plate
intraocular lenses for high myopia. J Refract Surg. 1999;15(5):
581).
Figure 2-13. STAAR implantable contact lens
(reprinted with permission from Zaldivar R,
Oscherow S, Ricur G. The STAAR posterior chamber
phakic intraocular lens. Int Ophthalmol Clin. 2000;
40(3):237-244).
eter and variable dimensions for the foot-plate. In the V2
model, the footplate dimensions remained constant and
the optic diameter was variable. The optic diameter was
inversely proportional to the diopter strength. The optical
diameter was optimized in the V3 model. By changing the
concave base radius to 11.0 mm, increased anterior vault-
ing of the ICL was introduced in the V4 model in 1998.24
The ICL is now available for the treatment of myopia and
hyperopia.26
Currently, there are three main types of phakic IOLs
for the treatment of myopia and hyperopia in clinical use:
AC angle-fixated IOLs, PC IOLs, and iris-supported IOLs.
The AC lens is represented by the Baïkoff or NuVita
lens (Bausch & Lomb Surgical, Rochester, NY).20 Other
AC phakic lenses have also been developed, such as the
Phakic 6 (Ophthalmic Innovations International Inc,
Ontario, Canada) and ZSAL (Morcher GMBH, Stuttgart,
Figure 2-12. Prototype
of the composite im-
plant of the anterior
chamber (reprinted with
permission from Baïkoff
G. Intraocular phakic
implants in the anterior
chamber. Int Ophthal-
mol Clin. 2000;40(3):
223-235).
Germany) implants, which have 6-mm optics in order to
reduce halos. Foldable AC implants have also been
described, although there is some concern regarding their
stability. The composite AC implant involves an unfold-
able supporting haptic made of PMMA and a foldable
optic of hydrophilic acrylic that can be introduced into
the AC through a 3.2-mm self-sealing incision (Figure
2-12). This lens was design by Baïkoff in an attempt to
provide better stability to a foldable AC lens.21
PC sulcus-fixated IOLs, such as the ICL (Figure 2-13),
are foldable and offer the advantage of insertion through a
small incision.
AC iris-fixated lenses, such as the Worst iris-claw lens
(which is represented in the United States by the Artisan
phakic IOL) (see Figures 2-7A and 2-7B) are undergoing
FDA-supervised trials for use in phakic eyes in the United
States.9,18
SUMMARY
The development of phakic IOLs has been one of trial
and error throughout the past century. Despite multiple
disappointing complications and due to the perseverance
of admirable surgeons, they have become a promising
alternative for the treatment of high degrees of myopia
and hyperopia available today.
REFERENCES
1. Fukala V. Heilung hochgradiger Kurzsichtigkeit. Von
Grafes Arch fur Ophthalmol. 1890;36:330.
2. Apple DJ, Sims JC. Harold Ridley and the invention of the
intraocular lens. Surv Ophthalmol. 1995;40:279-292.
3. Apple DJ, Auffarth GU, Peng Q, Vissessook N. Foldable
Intraocular Lenses: Evolution, Clinicopathologic Correla-
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riore nella afachia o nei vizi di refrazione. Annali di
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phakic eyes. Refract Corneal Surg. 1990;6:252.
12. Mimouni F, Colin J, Koffi V, et al. Damage to the corneal
endothelium from anterior chamber intraocular lenses in
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13. Saragoussi JJ, Cotinat J, Renard G, et al. Damage to the
corneal endothelium by minus power anterior chamber
intraocular lenses. Refract Corneal Surg. 1991;7:282-285.
14. Fechner PU, van der Heijde JL, Worst JJ. The correction of
myopia by lens implantation into phakic eyes. Am J
Ophthalmol. 1989;107(6):659-663.
15. Fechner PU, Strobel J, Wiechmann W. Correction of
myopia by implantation of a concave Worst-iris-claw lens
into phakic eyes. Refract Corneal Surg. 1991;7(4):286-298.
The History of Phakic Intraocular Lenses 19
16. Fechner PU, Worst JGF. A new concave intraocular lens for
the correction of myopia. European Journal of Implant and
Refractive Surgery. 1989;1:41-43.
17. Alpor JJ, Fechner PU. Intraocular Lenses. New York, NY:
Thieme; 1986:328-335.
18. Fechner PU, Haubitz I, Wichmann W, et al. Worst-Fechner
biconcave minus power phakic iris-claw lens. J Refract Surg.
1999;15(2):93-105.
19. Menezo JL, Avino JA, Cisneros AL, et al. iris-claw phakic
intraocular lens for high myopia. J Refract Surg. 1997;
13:545-555.
20. Baïkoff G, Arne JL, Bokobza Y, et al. Angle-fixated anterior
chamber phakic intraocular lens for myopia of -7 to -19
diopters. J Refract Surg. 1998;14(5):282-293.
21. Baïkoff G. Intraocular phakic implants in the anterior cham-
ber. Int Ophthalmol Clin. 2000;40(3):223-235.
22. Fedorov SN, Zuev VK, Tumanian ER. Intraocular correc-
tion of high-degree myopia. Vestn Oftalmol. 1988;104(2):
14-16.
23. Fyodorov SN, Zuyev VK, Aznabayev BM. Intraocular cor-
rection of high myopia with negative posterior chamber
lens. Ophthalmosurgery. 1991;3:57-58.
24. Abela-Formanek C, Kruger AJ, Dejaco-Ruhswurm I, et al.
Gonioscopic changes after implantation of a posterior
chamber lens in phakic myopic eyes. J Cataract Refract
Surg. 2001;27(12):1919-1925.
25. Jimenez-Alfaro I, Benitez del Castillo JM, Garcia-Feijoo J, et
al. Safety of posterior chamber phakic intraocular lenses for
the correction of high myopia: anterior segment changes
after posterior chamber phakic intraocular lens implanta-
tion. Ophthalmology. 2001;108(1):90-99.
26. Sanders DR, Martin RG, Brown DC, et al. Posterior cham-
ber phakic intraocular lens for hyperopia. J Refract Surg.
1999;15:309-315.

Patient Selection for
Phakic Intraocular Lenses
Brian J. Snyder, OD and Elizabeth A. Davis, MD, FACS
INTRODUCTION
High refractive errors are difficult to correct optically
and surgically. Traditional options for correcting refractive
error—spectacles and contact lenses—have less than opti-
mal performance as refractive error increases. Both high
myopes and hyperopes experience distorted peripheral
vision with optical correction due to increased radial astig-
matism and curvature of field. The diminished quality of
vision and poor cosmesis of glasses cause many of these
patients to rely heavily on contact lenses. Unfortunately,
there are fewer contact lens options for the extreme
myope and hyperope than there are for the mild to mod-
erate ametrope. Patients intolerant of rigid gas permeable
lenses may be forced to wear conventional, yearly replace-
ment lenses instead of utilizing a more frequent replace-
ment schedule. A frequent replacement schedule, such as
every 2 weeks or even every day, is healthier for the eye;
however, lenses for extreme ametropes are simply not
manufactured in those parameters. Contact lens wear caus-
es corneal hypoxia, especially when thicker lens designs
needed for correcting high refractive errors are combined
with longer wearing time. Hypoxia, in turn, increases the
risk for complications like keratitis and corneal neovascu-
larization. It also accelerates endothelial cell loss.
With the advent of corneal refractive surgery, alterna-
tive treatments for correcting refractive errors became
available. Radial keratotomy, which is one of the first
refractive surgeries developed, is limited to corrections of
no more than -5.00 diopters (D). Long-term instability of
the cornea with ectasia created by the incisions and the
subsequent and progressive hyperopia have all but elimi-
3
Chapter
nated its use as a standard refractive procedure. The
increased risk of subepithelial haze for moderate to high
myopes treated with photorefractive keratectomy (PRK)
makes this option less than ideal. Newer PRK techniques,
like laser-assisted subepithelial keratectomy (LASEK) and
intraoperative use of mitomycin C, may help to decrease
the occurrence of haze formation.1,2 Regression rates of
both PRK and LASIK increase, however, as the amount of
correction increases. Excimer laser procedures for high
myopia create an oblate cornea and may decrease contrast
sensitivity and increase higher order aberrations.
Additionally, there are concerns of iatrogenic keratectasia
with high ablation depths.
Other refractive procedures for myopia have been
developed recently to maintain prolate corneas and avoid
potential keratectasia. INTACS intracorneal ring segments
(ICRS) (Addition Technology, Des Plaines, Ill) are insert-
ed into the midperipheral cornea. The arc shortening
mechanism of ICRS maintains the positive asphericity of
the cornea (ie, the curvature of the central cornea remains
steep compared to the peripheral cornea). INTACS, how-
ever, demonstrated limited clinical success in cases of low
to moderate spherical myopia.3 For the hyperope, a simi-
lar though opposite effect is created with conductive ker-
atoplasty (CK). Midperipheral contraction created by the
thermal effects of the CK treatment results in central
steepening and retains the prolate nature of the natural
cornea. The nomogram for CK has demonstrated modest
success for refractive errors less than +3.00 D but has not
been shown to reliably correct astigmatism.4 Neither ICRS
nor CK subtract tissue from the cornea, thus reducing con-
cerns of keratectasia.
22 Chapter 3

Table 3-1

COMPARISON OF PHAKIC IOL DESIGNS

CIBA/Medennium
Ophtec Artisan STAAR ICL PRL OII Phakic 6
Lens Type Iris-fixated Posterior chamber Posterior chamber Angle-fixated
Lens Power
Myopia -5.00 to -20.00 D -3.00 to -20.00 D -3.00 to -20.00 D -2.00 to -25.00 D
(6 mm OZ)
-5.00 to -15.00 D
(5 mm OZ)
Hyperopia +3.00 to + 12.00 D +3.00 to +12.00 D +3.00 to +15.00 D +2.00 to +10.00 D
Material Polymethylmeth- Collagen/hydroxy- Silicone PMMA with
acrylate (PMMA) ethyl methacrylate heparin
(HEMA) copolymer
Optical Zone
Myopic lens 5.00 or 6.00 mm 4.65 to 5.50 mm 4.50 to 5.00 mm 6.00 mm
Hyperopic lens 6.00 mm 5.50 mm 4.50 to 5.00 mm 6.00 mm
Length
Myopic lens 8.5 mm 11.5 to 13.5 mm 11.3 mm 12.00 to 14.00 mm
Hyperopic lens 8.5 mm 11.0 to 13.0 mm 10.8 mm 12.00 to 14.00 mm
Incision Size 6.0 mm 3.0 mm 3.2 mm 7.0 mm
Minimum required 3.2 mm 2.8 mm (measured 3.0 mm 3.0 mm
anterior chamber from the endo-
depth thelium

The emergence of the phakic intraocular lens (IOL) in PATIENT SELECTION

the past two decades has given new hope to the extreme
ametrope. Strampelli and Barraquer used the first phakic
IOLs—anterior chamber angle-fixed lenses—in the 1950s.
Early surgical techniques and limited knowledge of corneal
physiology led to corneal edema and chronic uveitis, and
the lenses were soon abandoned. There are currently four
phakic IOL designs under US Food and Drug
Administration (FDA) consideration: the Artisan (Ophtec
BV, Groningen, Netherlands), the STAAR Implantable
Contact Lens (ICL) (STAAR Surgical AG, Nidau,
Switzerland), CIBA Phakic Refractive Lens (PRL) (CIBA
Vision, Duluth, Ga), and the OII Phakic 6 lens (Ophthalmic
Innovations International Inc, Ontario, Canada) (Table 3-
1). The predecessor to the Artisan lens, the Worst-Fechner
iris-claw lens, was first used in 1986, while, at the same time,
Fyodorov was implanting posterior chamber lenses that
were to be early generations of the current STAAR ICL. A
more detailed history of the evolution of lens design can be
found in other chapters of this text.
The refractive outcomes of LASIK when compared to
the phakic IOL have been shown to be similar in cases of
myopia between -8 and -12 D.5 Surgeon discretion will
determine appropriate treatment in these borderline cases
when pachymetry is adequate and topography is normal.
Some of these patients may have irregular corneal
topographies that classify them as keratoconus suspects.
Despite good spectacle corrected vision and a refractive
error that has been stable for many years, a cautious refrac-
tive surgeon may advise against corneal refractive surgery
in keratoconus suspects (Figure 3-1).
PATIENT HISTORY
A thorough patient history is an important part of every
exam, especially for any patient considering an elective
surgery. To the astute observer, the case history offers
more than a chance to gather data; it provides an opportu-
Patient Selection for Phakic Intraocular Lenses 23

Figure 3-1. Preoperative Orb-

scan analysis of a 45-year-old
Caucasian male who presented
for a refractive evaluation. Note
the inferior steepening in the tan-
gential power map (lower left
image of the printout).
Preoperative manifest refraction
was -5.75 + 0.75 x 028 OD and
-6.75 + 1.25 x 072. This corneal
topography was consistent with
an ectatic dystrophy, disqualify-
ing the patient for LASIK. It was
decided to proceed with Artisan
IOL implantation in the left eye
followed by the right eye
4 months later. At the 6-month
postoperative visit, the left eye
was 20/40 uncorrected. At the
6-week postoperative visit, prior
to suture removal, the right eye
was 20/50 uncorrected, with
BCVA of 20/25.

B
24 Chapter 3

Table 3-2

RELATIVE CONTRAINDICATIONS FOR PHAKIC IOL

• Visually significant cataract • Chronic uveitis
• Low endothelial cell count • Abnormality of the iris
• Diabetic retinopathy • Abnormality of the anterior angle
• Glaucoma • Any form of progressive vision loss

nity to assess the motivations and expectations of the
patient. Establishing realistic expectations is the first step
toward a positive outcome. Making a note of how the
patient expresses his or her expectations of the surgery is
useful. For example, does he or she use words like “20/20”
or “life without any glasses”? The many successes of LASIK
have shifted focus from functional uncorrected vision and
lifestyle changes to expectations like “20/20 the next day.”
Learning about a patient’s occupation and avocations is
important in determining goals and visual needs.
The patient should be questioned carefully about any
history of amblyopia, stability of refraction, and satisfac-
tion with wearing glasses or contact lenses. Best-corrected
visual acuity (BCVA) of 20/25 or 20/30 may be normal in
high myopes due to the minification caused by spectacle
lenses. These patients may prefer contact lenses for this
reason and report that they see better with their contacts.
BCVA less than 20/30, especially in the hyperope, should
raise questions about amblyopia and warrants further
investigation into amblyogenic factors. The surgeon
should inquire about the patient’s age of first spectacle cor-
rection and any history of strabismus. Refractive stability
is also important. Frequent changes in glasses prescriptions
and/or constantly increasing amounts of sphere or cylinder
may indicate a condition such as keratoconus or pellucid
marginal degeneration. On the other hand, the patient
who has corneal topography with asymmetric astigmatism
and/or inferior steepening but with a stable refractive error
and no clinical signs of keratoconus may be a candidate for
a phakic IOL. A thorough history will also uncover possi-
ble contraindications to implant surgery (Table 3-2).
AGE
Age is an important factor when considering a candi-
date for implant refractive surgery. In the high ametrope,
who is not a candidate for LASIK, age may be the decid-
ing factor between remaining phakic or becoming
pseudophakic. The concept of presbyopia should be clear-
ly explained when counseling any refractive surgery can-
didate. The surgeon should discuss several factors with the
patient: phakic IOL implantation, presbyopia, and senile
cataract formation. The longer the time period is between
factors one and two, the more benefit a patient receives
from implanting the phakic IOL. The risk-to-benefit ratio
may be considered lowest if the time between factors one
and three is maximized. Unfortunately, the time at which
a patient enters presbyopia is more predictable than the
age at which a senile cataract will develop.
The surgeon should also take into account how age-
related changes to the lens affect the anterior chamber
depth. The anterior chamber has been shown to shallow
with age, most likely as a result of continued growth of the
crystalline lens.6 Therefore, the younger the patient, the
more important it may be that he or she has sufficient
anterior chamber depth to allow for this occurrence. This
may lead surgeons to adopt minimum chamber depths
based on age.
PUPIL SIZE
Pupil size is also extremely important in patient selec-
tion for phakic implant refractive surgery. The optical
zone of the implant limits the maximum scotopic pupil
size allowed. Glare and halos from pupils larger than the
optical zone can be a nuisance at best, debilitating at
worst, and cause for explantation of the lens. Pupil size,
however, is not an absolute contraindication in the moti-
vated patient. A patient with a large scotopic pupil may
still wish to proceed with surgery after careful explanation
and education on the risks of glare and halos. Many of
these patients may feel they have glare and halos with
their current forms of vision correction and may be willing
to trade these potential side effects for the decreased
dependence on glasses or contacts. It is advised that stan-
dard, metered, and reproducible scotopic lighting condi-
tions be used for testing pupils. A scotopic illuminance
level of 0.5 to 0.6 lux has been recommended.7 An assess-
ment of pupil size should be taken at each preoperative
visit and an accurate medical history elicited to uncover
any medication that may affect pupil size, such as antide-
pressants and antihistamines.
 Patient Selection for Phakic Intraocular Lenses 25

A B
Figure 3-2. Preoperative specular microscope evaluation of a 33-year-old Caucasian female who presented for a refractive evalua-
tion. Note the pleomorphism and polymegathism of the cells as well as the cell density (CD) of 2577 OD and 2518 OS. She was
asymptomatic and slit lamp exam confirmed a diagnosis of posterior polymorphous dystrophy based on the scalloped irregular
appearance of the endothelium. Her manifest refraction was -10.50 + 3.75 x 095 OD and -10.75 + 1.75 x 085 OS with a pachym-
etry of 537 and 534, respectively. Because this was considered a nonprogressive endothelial cell condition, she proceeded with
Artisan IOL implantation in the left eye followed by implantation in the right eye 8 months later. At the 8-month postoperative visit
OS and 6 weeks postoperative OD uncorrected visual acuity was 20/60, OD, OS, due to residual myopia, with best spectacle-cor-
rected visual acuity 20/20, OD, OS.

CORNEAL EVALUATION higher incidence of corneal touch and decompensation.

A careful and thorough slit lamp examination is essen-
tial in ruling out any problems that may lead to an unsat-
isfactory surgical and refractive outcome. Corneal anom-
alies that are not considered visually significant and non-
progressive could be considered relative contraindications,
whereas progressive and visually deleterious conditions
should be classified as absolute contraindications (Figure
3-2). Other instruments that can help with this evaluation
are the corneal topographer and the noncontact specular
microscope. Corneal topographers are indispensable
instruments to the refractive surgeon and should be used
to screen all patients interested in corneal refractive sur-
gery in order to detect patients with irregular corneal sur-
faces. Endothelial cell density, as determined by specular
microscopy, is another important index of corneal health
and stability and should be considered important to the
surgeon performing phakic or pseudophakic intraocular
surgery.
ANTERIOR CHAMBER EVALUATION
Determination of the anterior chamber depth is also of
importance in the evaluation of the phakic IOL candidate.
Adequate distance between the implant and the posterior
surface of the cornea is essential in minimizing damage to
the endothelium and ensuring the long-term health of the
cornea. Past lens designs had high vaults that resulted in a
The high myope frequently has a deep anterior chamber;
therefore, most of these patients will not have a problem
meeting minimum chamber depth requirements.
Unfortunately, as hyperopia increases, axial length and
anterior chamber depth decrease. A shallow anterior
chamber depth is often what precludes the high hyperope
from phakic IOL implantation. As lens designs improve, it
is hoped that the minimum chamber depth will decrease,
making phakic IOLs a viable option for the high hyperope
with a shallow chamber.
The anterior angle configuration is a second important
aspect of the anterior chamber to assess. This is equally
important for anterior chamber and posterior chamber pha-
kic IOLs. It has been observed that the sulcus placement of
the posterior chamber lens haptics can cause changes to the
angle structure over time. Ultrasound biomicroscopy has
also shown that current posterior chamber-style lenses do
come into contact at times with the pigmented epithelium
on the posterior surface of the iris.8 Therefore, it is impor-
tant to document angle configuration and pigmentation
prior to surgery, should any changes occur.
PATIENT EDUCATION/
PATIENT COUNSELING
Whether he or she has done extensive internet research,
saw a special feature on the nightly news, or knows that one
of his or her family members or coworkers has had the pro-
26 Chapter 3
Table 3-3
POSSIBLE COMPLICATIONS THAT SHOULD BE INCLUDED ON AN
INFORMED CONSENT FOR PHAKIC IMPLANT SURGERY FORM
• Glare/halo
• Increased astigmatism
• Loss of best spectacle-corrected visual acuity
• Under/over correction
• Corneal edema
• Hyphema
• Intraocular infection
• Iritis/uveitis
cedure, chances are the patient who comes in for an evalua-
tion for refractive surgery knows something about LASIK.
Two of the appealing aspects of LASIK are the quick visual
recovery from the surgery and the short duration of the pro-
cedure. It is important to explain the differences between
LASIK and refractive implant surgery. LASIK is an extraoc-
ular procedure, whereas phakic IOL surgery is intraocular.
While LASIK has near immediate visual recovery in most
cases, phakic IOL surgery may take 1 to 3 months to stabi-
lize. While LASIK is often times done as a bilateral proce-
dure, patients must understand that phakic IOLs are typi-
cally implanted one eye at a time. More importantly, they
need to be prepared for a period of anisometropia in the
interim between the two surgeries. Contact lens placement
in the nonoperated eye achieves the best correction and
minimizes aniseikonia during this time.
For obvious ethical and legal reasons, the risks, benefits,
and alternatives for any treatment should be clearly
explained to the patient in language that he or she can eas-
ily understand (Table 3-3). Clearly, refractive surgery is an
elective procedure and this should be emphasized. The
patient always has the option of nonsurgical correction.
The most serious risks related to phakic IOLs are pri-
marily a result of the surgical procedure of implantation.
The incidence of complications like endophthalmitis,
intraocular bleeding, and inflammation, fortunately, are
very low but can be vision threatening. Surgical complica-
tions specific to phakic IOL placement include decentered
or displaced lenses. Glare and halos due to mismatched
optic vs pupil size can be avoided with careful testing and
proper preoperative screening. Patients should be educat-
ed about the possibility of under and over correction with
phakic IOLs. They should be informed that, postopera-
• Macular edema
• Lens dislocation
• Cataract formation
• Secondary glaucoma
• Pupillary block glaucoma
• Retinal detachment
• Additional surgery to remove or replace the
implant
tively, IOL exchange, LASIK or PRK (bioptics), or con-
ventional treatments, like spectacle or contact lenses,
might be needed to fully correct vision.
Long-term complications, such as corneal endothelial
decompensation and cataract formation, should also be
discussed and presented as a reason for good follow-up
care in the years after the surgery. Retinal complications,
such as detachments and macular holes, should also be dis-
cussed. The high myope is at a higher risk for developing
retinal complications that are unrelated to the surgery. As
lens designs continue to improve and surgeon experience
increases, both the operative and postoperative complica-
tion rates should decrease.
Given the current state of technology of the phakic
IOL and the inability at this time to tailor the implant to
the patient’s refractive error, it is important to tell the
patient that a realistic goal is decreased dependence from
other optical devices. Hence, he or she should not expect
to be completely free from some additional form of vision
correction. Myopes who primary rely on spectacles may
have an added benefit of retinal image magnification rela-
tive to their glasses. This can often times result in
improved BCVA.9 Additional benefits include maintaining
the integrity of the central cornea and preserving its natu-
ral prolate shape. This may preserve contrast sensitivity
when compared to other types of refractive surgery and
make postoperative contact lens fitting easier.
A final alternative for highly ametropic patients is clear
lens extraction. This is not a perfect solution, as it carries
a similiar surgical risk as phakic IOL implantation, an
increased risk for retinal detachment, and results in a loss
of natural accommodation.10
 Patient Selection for Phakic Intraocular Lenses
SUMMARY
The high myope and hyperope are often poor candi-
dates for corneal laser vision correcting surgery. On the
other hand, with proper patient selection and counseling,
these same patients may do extremely well with phakic
IOLs. With the US FDA approval of these lenses, we are
likely to witness an increasing number of patients choos-
ing this option for refractive surgery.
REFERENCES
1. Shahinian L. Laser-assisted subepithelial keratectomy for
low to high myopia and astigmatism. J Cataract Refract
Surg. 2002;28(8):1334-1342.
2. Carones F, Vigo L, Scandola E, Vacchini L. Evaluation of
the prophylactic use of mitomycin-C to inhibit haze forma-
tion after photorefractive keratectomy. J Cataract Refract
Surg. 2002;28(12):2088-2095.
3. Shanzlin DJ, Abbott RL, Asbell PA, et al. Two-year out-
comes of intrastromal corneal ring segments for the correc-
tion of myopia. Ophthalmology. 2001;108:1688-1694.
4. McDonald MB, Hersh PS, Manche EE, et al. Conductive
keratoplasty for the correction of low to moderate hyper-
opia: U.S. clinical trial 1-year results on 355 eyes.
Ophthalmology. 2002;109:1978-1989.
27
5. Malecaze FJ, Hulin H, Bierer P, et al. A randomized paired
eye comparison of two techniques for treating moderately
high myopia. Ophthalmology. 2002;109:1622-1630.
6. Hosny A, Alio JL, Claramonte P, Attia WH, Perez-Santonja
JJ. Relationship between anterior chamber depth, refractive
state, corneal diameter, and axial length. J Refract Surg.
2000;16:336-340.
7. Schnitzler EM, Baumeister M, Kohnen T. Scotopic meas-
urement of normal pupils: Colvard versus video vision ana-
lyzer infrared pupillometer. J Cataract Refract Surg.
2000;26(6):859-866.
8. Jimenez-Alfaro I, Benitez del Castillo JM, Garcia-Feijoo J,
Gil de Barnabe JG, Serrano de la Iglesia JM. Safety of pos-
terior chamber intraocular lenses for the correction of high
myopia. Ophthalmology. 2001;108:90-99.
9. Van der Heijde GL. Some optical aspects of implantation of
an IOL in a myopic eye. Eur J Implant Refract Surg.
1989;1:245-248.
10. Colin J, Robinet A, Cochener B. Retinal detachment after
clear lens extraction for high myopia. Ophthalmology.
1999;106:2281-2285.

Preoperative Diagnostic Testing
for Phakic Intraocular Lenses
Tina M. McCarty, OD, FAAO and David R. Hardten, MD, FACS
INTRODUCTION
As with any surgical procedure, there are critical factors
in the preoperative evaluation and diagnostic evaluation
for phakic intraocular lenses (IOLs). To have a good
understanding of risk and to improve surgical outcome,
this chapter will focus on endothelial cell counts and sul-
cus measurements. When analyzing endothelial cell
counts, the surgeon needs to understand what the normal
history of the aging corneal endothelium is and under-
stand the factors that influence a healthy endothelium.
The surgeon should also be familiar with what has been
published previously regarding endothelial cell counts and
phakic IOLs. Finally, this information can be comprised to
make a good surgical decision for the patient. Sulcus meas-
urements will also be described, including how they are
attained and why they are so critical.
ENDOTHELIAL CELL COUNTS
There are three basic factors that the health of the
endothelium is classified by when evaluating the corneal
endothelium. The first is the density of the endothelial
cells (ie, cell density) (Figures 4-1 to 4-4). The second is
the shape of the cells (ie, polymorphism) with hexagonal
cells being the most normal shape (see Figures 4-1 to 4-4).
Finally, the amount of variation in the size of the cells is
also important (ie, polymegathism, or coefficient of varia-
tion) (see Figures 4-1 to 4-4). There are many factors that
can influence the health of the corneal endothelium. First,
history of contact lens use (ie, the type of lens, frequency,
4
Chapter
duration in hours per day, and years of use). Other factors
that can contribute to the corneal endothelial health are
surgical trauma, chemical or physical agents, or pH
change.1 Finally, underlying dystrophy or disease can con-
tribute to change.
Effect of a Contact Lens on
Endothelium
The typical patient that undergoes surgery for a phakic
IOL implant is a high myope. Because these patients have
spectacles that are cosmetically unappealing, they often
wear contact lenses for several years and during all waking
hours of the day. Therefore, it becomes critical for us to
know if the endothelium is compromised to start with
before we have qualified the patient for surgery.
Chang et al conducted a study to determine how the
corneal endothelium was affected by soft contact lens
wear.2 The study had three groups: a control (n = 116),
patients who wore soft contact lenses for less than 5 years
(n = 34), and patients who wore soft contact lenses for
more than 5 years (n = 42). The authors found that the
percent of hexagonal cells decreased with increased dura-
tion of soft contact lens wear. This occurred as duration
was measured in hours per day and length in years of wear.
When looking at the polymegathism (ie, coefficient of
variation), there was a direct correlation in increased vari-
ation in cell size with increased duration in hours per day
(note: the duration in years of wear did not matter as
much). The authors noted that the cornea also became
thinner with increased duration of soft contact lens use.
30 Chapter 4
Figure 4-1. Specular microscopy image of a cornea with normal
endothelial cell density and relatively small amounts of poly-
megathism or polymorphism.
Figure 4-3. Specular microscopy image of a cornea with areas of
corneal guttata in which endothelial cells are missing, and the
density in other areas is very low with significantly increased
size of the endothelial cells. This patient has a remote history of
corneal transplant rejection. This patient would have a higher
risk of endothelial decompensation with intraocular surgery.
Finally, the study did not report a significant change in
endothelial cell density in contact lens wearers compared
to the controls.
A similar study conducted by Lee et al3 also studied the
effects of soft contact lens use as measured in different
durations (years of use) on the corneal endothelium. This
study correlated with the previously mentioned study in
which the authors found that increasing years of soft con-
tact lens use decreased the percentage of hexagonal cells.
The authors also found that contact lens wearers had a
greater coefficient of variation when compared to non-
contact lens wearers. In contrast to the previous study, Lee
Figure 4-2. Specular microscopy image of a cornea with areas
of corneal guttata in which endothelial cells are missing, yet the
density in other areas is relatively normal. This eye has a slight-
ly higher amount of polymorphism and polymegathism. This
patient would have only a slightly higher risk of endothelial
decompensation with intraocular surgery.
Figure 4-4. Specular microscopy image of a cornea with a wide
variety of shapes and significant polymorphism and poly-
megathism. This patient would not have a higher risk of endothe-
lial decompensation with intraocular surgery.
et al found that cell density decreased among the contact
lens wearers.3
Similar findings with rigid gas permeable (RGP) or
polymethylmethacrylate (PMMA) contact lens wear are
published. Endothelial polymegathism, pleomorphism,
and decreased cell density are induced with PMMA wear.4
Polymegathism and pleomorphism are induced with high
oxygen permeability (Dk) gas permeable contact lens
wear.5 It does not appear that RGP wear has an effect on
endothelial cell density.
 Preoperative Diagnostic Testing for Phakic Intraocular Lenses
Endothelium Over a Lifetime
When determining if the endothelial cell measurement
is healthy enough to be able to proceed with a phakic IOL
or determining if the patient is developing problems or
loss or change of cells postoperatively, it is important to
understand the normal human corneal endothelium and
the aging process of this endothelium over a lifetime.
Mustonen et al conducted a study to measure central
corneal cell population looking at 58 eyes of 45 patients.6
All patients had normal corneas without history of trauma,
disease, or contact lens use. The mean age was 45 years
with a standard deviation of 17. The range was 20 to 84.
The corneas were measured in vivo with a scanning slit
confocal microscope. The average density of endothelial
cells was found to be 3055 + 386 cells/mm2, with a range
from 1809 to 3668. As expected, the authors found that
endothelial cell density decreases with age, with the
largest drop occurring after 80 years of age. There was no
correlation between gender or right or left eyes.6
A much larger study conducted by Abib and Barreto
retrospectively looked at 784 corneal specular microscop-
ic examinations. All subjects had healthy corneas and no
history of contact lens use. The patients were grouped
according to age in 10-year intervals from 0 to 100 years.
The actual age of patients included in the study was 6 to
97 years old. The study found that the endothelial cell
density decreased over time following a linear model. As
the cell density decreased, the standard deviation
increased. The probability of a cell density less than 2000
cells/mm2 increased starting in the seventh decade and
moving on.7
Endothelial Cell Measurement
Preoperative endothelial cell analysis is especially
important in those patients with previously documented or
suspected abnormalities of the endothelial cells. Either slit-
scanning corneal microscopy or specular microscopy may
analyze endothelial cells. Generally, noncontact specular
microscopy is the standard method for determining cell
density, polymegathism, and pleomorphism. There are
two models of noncontact specular microscopes available:
the Konan (Konan Medical Corp, Fairlawn, NJ) and the
Topcon (Topcon, Paramus, NJ).8 There are different com-
puter analysis systems to be used with the microscopes.
Important emphasis needs to be placed on the reliability
and reproducibility of the results obtained from these sys-
tems. There can be a wide variability in the outcome vari-
able depending upon how specific computer software is
used (ie, automated, semiautomated, or manual).9 In addi-
tion to the wide variety of outcome dependent on soft-
ware, intertechnician variability is very possible. Benetz et
al conducted a study to compare different image-analysis
systems. The authors concluded that the Konan SP8000
31
system has the potential to be reliable and useful for a
large-scale clinical trial, especially when the dot method
for cell density is utilized.8
ANTERIOR CHAMBER
INTRAOCULAR LENS EFFECT
ON C ORNEAL E NDOTHELIUM
There have been several reports that have documented
progressive endothelial cell loss/compromise with the
implant of an anterior chamber IOL in a phakic eye. It needs
to be determined if the surgical procedure itself is inducing
the change, if the patient had compromised endothelium to
begin with, or if it is the placement of the lens in the ante-
rior chamber that is causing the change.10-12
A study conducted by Perez-Santonja et al11 compared
the loss of central endothelial cell count measured by spec-
ular microscopy after implantation of the Worst-Fechner
(now the Artisan) iris-claw lens (Ophtec BV, Groningen,
Netherlands) in 30 eyes to the Baïkoff ZB 5M angle sup-
ported lens (Domilens, Lyon, France) in 28 eyes. The
authors found progressive endothelial cell density loss in
both groups. The cell loss in the Worst-Fechner lens
group was 7.3% at 3 months, 10.6% at 6 months, 13.0% at
12 months, and 17.6% at 24 months. The cell loss in the
Baïkoff ZB 5M lens group was 7.5% at 3 months, 10.9% at
6 months, 12.2% at 12 months, and 12.2% at 24 months.
The measurements were statistically significantly
decreased in both groups for all time points except
between the 12- and 24-month time point in the Baïkoff
group. The Baïkoff lens group appeared to have a stable
cell density after 1 year.11
Without longer follow-up, it is difficult to speculate
why cell loss stabilized in the Baïkoff group, while the cell
loss was progressive in the Worst-Fechner lens group. It
has been speculated that the close proximity between the
lens and the cornea could cause endothelial loss secondary
to intermittent lens-to-cornea touch potentially occurring
due to eye rubbing.12 There have been additional sugges-
tions that a chronic low grade uveitis may be associated
with progressive endothelial cell loss.13,14 This study did
not evaluate the size or shape of the endothelial cells; it
described density alone.
A study using a laser flare-cell meter evaluated the flare
in the anterior chamber of patients that had the Worst-
Fechner IOL or the Baïkoff ZB 5M lens and found that the
postoperative flare was higher in the Worst-Fechner lens
group. Although the study found chronic subclinical
inflammation at all time points (12, 18, and 24 months),
the flare was greater in the Worst-Fechner group. None of
the points had a statistically significant difference between
groups.14
32 Chapter 4
A later study with a longer follow-up evaluated both
endothelial density and morphometric change, and it
appeared as though the loss of endothelial density was
related more to the surgical procedure itself. Menezo et al
conducted a study that involved 111 eyes that underwent
phakic IOL implantation with a Worst iris-claw lens.15
Although cell loss was documented, it was less than in ear-
lier studies. Mean cell loss at 6 months was 3.9%, 12
months was 6.6%, 2 years was 9.2%, 3 years was 13.4%,
and 4 years was 13.4%. Cell loss was greater in eyes with
a shallower anterior chamber depth. In addition, there was
a greater loss of cells in those eyes implanted with a high-
er power lens. Both of these findings were significant at
the 6-month visit only; these variables were less significant
in the late postoperative period. This suggests that it is
possible to have the lens come into greater contact with
the endothelium with a shallow anterior chamber, espe-
cially if the lens is of a larger diameter.
Interestingly, in the Menezo et al study, the polymor-
phism and polymegathism were near preoperative levels at
the 2-year postoperative visit. At 4-years postop, there was
no statistical significant difference between preoperative
and postoperative values in cell shape or size.15 According
to Shaw et al,16 the morphology of the corneal endothe-
lial cell is the critical factor contributing to the functional
reserve of the cornea. It is the shape and size of the
endothelial cell that give the most sensitive indication of
cell damage rather than cell density alone.16
Lastly, the Menezo et al study suggests that there is no
chronic uveitis present with the Worst lens. Iris angiogra-
phy was completed in 15 eyes at 6 months postop and no
blood-aqueous barrier breakdown was seen.15 These find-
ings continue to suggest that the reported endothelial cell
loss is a consequence of the surgery itself and not the con-
tinued presence of the anterior chamber lens in place.
POSTERIOR CHAMBER
INTRAOCULAR LENS EFFECT
ON C ORNEAL E NDOTHELIUM
There are similar reports of documented cell loss asso-
ciated with implantation of a posterior chamber phakic
IOL in addition to reported cell loss associated with
implant of an anterior chamber phakic IOL.
In a study conducted by Jimenez-Alfaro et al,17 20 eyes
underwent implantation of the STAAR posterior chamber
phakic IOL (PCPIOL) (STAAR Surgical AG, Nidau,
Switzerland). Several factors were evaluated to determine
the safety of the procedure. The authors found that central
endothelial cell density decreased significantly after the
surgery. One limitation of this study is that the patients
were only followed for 2 years. Cell loss was 4.4% at 3
months, 4.8% at 6 months, 5.2% at 12 months, 5.5% at 18
months, and 6.6% at 24 months.17
Dejaco-Ruhswurm et al conducted a similar study eval-
uating long-term changes to the corneal endothelium with
a STAAR PCPIOL with similar findings. Cell loss was
1.8% at 3 months, 4.2% at 6 months, 5.5% at 12 months,
7.9% at 2 years, 12.9% at 3 years, and 12.3% at 4 years.
This study also evaluated morphometric changes, includ-
ing polymorphism (hexagonal cells) and polymegathism
(coefficient of variation), both of which remained stable
over the entire 4-year period.18
ENDOTHELIAL CELL
LOSS ASSOCIATED
WITH P HACOEMULSIFICATION
AND I NTRAOCULAR L ENSES
In both of the more comprehensive long-term studies
of anterior chamber phakic IOLs and posterior chamber
IOLs, it again appears that the endothelial cell loss is sur-
gically induced rather than induced later by the phakic
lens. It is well known that after any anterior segment sur-
gery procedure endothelial cell loss occurs proportional to
the length and type of surgery.19 It becomes important to
compare and contrast the data given for the phakic IOLs
to a surgical procedure that we are much more familiar
with in terms of long-term results. There are several pub-
lished studies documenting endothelial cell loss after pha-
coemulsification. The reports vary in different studies
ranging from 4% to 13% endothelial cell loss.20-23 This
reported density loss is very similar to the cell density loss
reported for a phakic IOL implant.
SULCUS MEASUREMENTS
The ciliary sulcus measurement is a very important factor
in determining the size of the PCPIOL selected for the
patient. It is this factor that determines the vault (ie, the
amount of separation between the Implantable Contact Lens
[ICL] [STAAR Surgical AG, Nidau, Switzerland] and the
natural lens). A current limitation of the PCPIOL is that we
do not have extremely accurate and reproducible methods
for determining this variable. If the lens diameter chosen is
too large, this can result in greater vault than desired, result-
ing in increased distance between the ICL and the natural
lens. This can result in increased contact between the poste-
rior surface of the iris and the ICL, leading to pigment dis-
persion and potentially putting the patient at higher risk for
developing glaucoma. If the ICL diameter chosen is too
small, the opposite occurs: the ICL and the natural lens are
in closer proximity, increasing risk for visually significant
cataract development. Ideally, the ICL would vault forward
enough to provide adequate space from the crystalline lens
but not vault too much to cause iris chaff and pigment
release.24
 Preoperative Diagnostic Testing for Phakic Intraocular Lenses
Typically, surgeons have determined sulcus size using
the white-to-white limbal measurement. The phakic ICL
size is then the white-to-white plus 0.5 mm for myopes
and white-to-white minus 0.5 mm, or the total white-to-
white measurement, for hyperopes.25 This method is indi-
rect and, therefore, not an accurate measurement of ciliary
sulcus diameter.24
Pop et al26 conducted a study to predict sulcus size with
the use of ocular measurements, including ultrasound bio-
microscopy to measure sulcus size, axial length, anterior
chamber depth, lens thickness, limbus size, and pachyme-
try. The authors did not find that sulcus size significantly
correlated with limbus size, suggesting that this is an inad-
equate means to measure the sulcus diameter. The authors
did find that sphere and mean corneal power most signifi-
cantly correlated to the sulcus size compared to all other
measurements. Utilizing multiple regression analysis, the
authors derived an equation relating sulcus size to other
ocular variables:
Sulcus size = 18.9 + -0.023 x sphere + -0.15 x mean ker-
atometry
This resulted in 24% total variance, statistical correlation
of 0.89, and an estimated standard error of 0.5 mm.26
Although the method described by Pop et al26 may be
an improvement over the traditional method of measuring
sulcus diameter by white-to-white, it is still potentially
limited due to the high probability of variation and the
fact that it has not been tested in a prospective fashion in
another set of eyes. With more accurate methods of sulcus
measurement, this potentially could improve surgical out-
comes when using an ICL.
SUMMARY
Although the use of phakic IOLs is certainly very excit-
ing for the correction of high refractive error, the lack of
long-term results continues to remain a concern. The later
long-term studies are promising with regard to stabiliza-
tion of endothelial cell loss. However, this will continue to
remain a concern simply due to the lack of ability for the
corneal endothelium to regenerate. A more accurate repro-
ducible method for determining ciliary sulcus size is need-
ed. Refinements in the techniques should allow continued
improvements in safety and efficacy.
REFERENCES
1. Leibowitz HM, Laing RA. Specular microscopy. In:
Leibowitz HM, ed. Corneal Disorders: Clinical Diagnosis
and Management. Philadelphia, Pa: WB Saunders;
1984:123-163.
2. Chang SW, Hu FR, Lin LL. Effects of contact lenses on
corneal endothelium—a morphological and functional
study. Ophthalmologica. 2001;215:197-203.
33
3. Lee JS, Park WS, Lee SH, et. al. A comparative study of
corneal endothelial changes induced by different durations
of soft contact lens wear. Graefes Arch Clin Exp
Ophthalmol. 2001;239:1-4.
4. Setala K, Vasara K, Vesti E, Ruusuvaara P. Effects of long-
term contact lens wear on the corneal endothelium. Acta
Ophthalmol Scand. 1998;76:229-303.
5. Esgin H, Erda N. Corneal endothelial polymegathism and
pleomorphism induced by daily-wear rigid gas-permeable
contact lenses. CLAO J. 2002;28:40-43.
6. Mustonen RK, McDonald MB, Srivannaboon S, et al.
Normal human corneal cell populations evaluated by in vivo
scanning slit confocal microscopy. Cornea. 1998;17:485-
492.
7. Abib FC, Barreto J. Behavior of corneal endothelial density
over a lifetime. J Cataract Refract Surg. 2001;27:1574-1578.
8. Bentez BA, Diaconu E, Bowlin SJ, et al. Comparison of
corneal endothelial image analysis by Konan SP8000 non-
contact and bio-optics Bambi systems. Cornea. 1999;18:67-
72.
9. Vecchi M, Braccio L, Orsoni JG. The Topcon SP 1000 and
Image-NET systems. Cornea. 1996;15:271-277.
10. Landesz M, Worst JGF, van Rij G. Long-term results of cor-
rection of high myopia with an iris-claw phakic intraocular
lens. J Refract Surg. 2000;16:310-316.
11. Perez-Santonja JJ, Iradier MT, Sanz-Iglesias L, et al.
Endothelial changes in phakic eyes with anterior chamber
intraocular lenses to correct high myopia. J Cataract Refract
Surg. 1996;22:1017-1022.
12. Mimouni F, Colin J, Koffi V, Bonnet P. Damage to the
corneal endothelium from anterior chamber intraocular
lenses in phakic myopic eyes. Refract Corneal Surg.
1991;7:277-281.
13. Rao GN, Stevens RE, Harris JK, Aquavella JV. Long-term
changes in corneal endothelium following intraocular lens
implantation. Ophthalmology. 1981;88:386-397.
14. Perez-Santonja JJ, Iradier MY, Benitez del Castillo JM, et al.
Chronic subclinical inflammation in phakic eyes with
intraocular lenses to correct myopia. J Cataract Refract
Surg. 1996;22:183-187.
15. Menezo JL, Cisneros AL, Rodriguez-Salvador V.
Endothelial study of iris-claw phakic lens: four year follow-
up. J Cataract Refract Surg. 1998;24:1039-1049.
16. Shaw EL, Rao GN, Arthur EJ, Aquavella JV. The functional
reserve of corneal endothelium. Ophthalmology. 1978;85:
640-649.
17. Jimenez-Alfaro I, Benitez del Castillo JM, Garcia-Feijoo J, et
al. Safety of posterior chamber phakic intraocular lenses for
the correction of high myopia. Ophthalmology. 2001;
108:90-99.
18. Dejaco-Ruhswurm I, Scholz U, Pieh S, et al. Long-term
endothelial changes in phakic eyes with posterior chamber
intraocular lenses. J Cataract Refract Surg. 2002;28:1589-
1593.
34 Chapter 4
19. Rao GN, Aquavella JV, Goldberg SH, Berk SL.
Pseudophakic bullous keratopathy. Relationship to preoper-
ative corneal endothelial status. Ophthalmology. 1984;91:
1135-1140.
20. Dick HB, Kohnen T, Jakobi EK, Jakobi KW. Long-term
endothelial cell loss following phacoemulsification through
a temporal clear corneal incision. J Cataract Refract Surg.
1996;22:63-71.
21. Hayashi K, Hayashi H, Nakao F, Hayashi F. Corneal
endothelial cell loss in phacoemulsification surgery with sil-
icone intraocular lens implantation. J Cataract Refract Surg.
1996;22:743-747.
22. Zetterstrom C, Laurell CG. Comparison of endothelial cell
loss and phacoemulsification energy during endocapsular
phacoemulsification surgery. J Cataract Refract Surg.
1995;21:55-58.
23. Diaz-Valle D, Benitez del Castillo Sanchez JM, Castillo A,
et al. Endothelial damage with cataract surgery techniques.
J Cataract Refract Surg. 1998;24:951-955.
24. Trindade F, Pereira F. Exchange of a posterior chamber pha-
kic intraocular lens in a highly myopic eye. J Cataract
Refract Surg. 2000;26:773-776.
25. Rosen E, Gore C. STAAR collamer posterior chamber pha-
kic intraocular lens to correct myopia and hyperopia.
J Cataract Refract Surg. 1998;24:596-606.
26. Pop M, Payette Y, Mansour M. Predicting sulcus size using
ocular measurements. J Cataract Refract Surg. 2001;27:
1033-1038.

Optics and Intraocular Lens
Power Calculations for
Phakic Intraocular Lenses
Jack T. Holladay, MD, MSEE, FACS
INTRODUCTION
Over the past 50 years, the goal of refractive surgery
has been to eliminate the refractive error of the eye in
order to achieve emmetropia. The measures of outcome
have included the uncorrected Snellen visual acuity, the
residual refractive error, incidence of retreatments, and
complications. These measures are no longer sufficient
with modern refractive surgery.1
Recent developments in the instrumentation and analy-
sis of wavefront technology have provided the tools to
analyze the optical elements of the eye independently and
collectively as a system.2-6 Studies using these new instru-
ments have demonstrated that the optical performance of
the human eye is much better in the young and that there
is a predictable, progressive decrease in the performance
of the eye with age.7-13 Most of the degradation in image
quality is due to changes in the crystalline lens.14-18
These studies have shown that the cornea and crys-
talline lens are optically coupled in a way in which the sum
of the elements is better than either element performing
independently. The cornea is prolate with an average
Q-value in the population of approximately -0.26 (Figure
5-1).19 The Q-value of a sphere is zero and the Q-value of
the perfect single surface for eliminating spherical aberra-
tion is -0.50, a parabola. Because the average cornea has a
Q-value midway between the sphere and the parabola, the
cornea has about half of the spherical aberration of a true
sphere. Because the cornea is not a simple single refracting
surface, the exact Q-value to eliminate spherical aberration
is -0.52.
5
Chapter
The crystalline lens, however, is dynamic and changes
with increasing spherical aberrations throughout life. The
crystalline lens has a negative spherical aberration in the
young that is almost equal and opposite to the remaining
positive spherical aberration in the cornea (Figure 5-2).15
The young eye is very well corrected, but as the crystalline
lens begins to age, the lens spherical aberration goes from
negative to positive, crossing zero at about age 40. The
result is a progressive increase in the total ocular spherical
aberration of the eye, with age starting shortly after birth
(Figures 5-3 and 5-4).
DEFINING OPTICAL
QUALITY OF THE HUMAN EYE
The optical quality of the eye can be evaluated by high
contrast Snellen acuity, wavefront analysis, and contrast
sensitivity. Other factors, such as color vision and visual
fields, are also important to visual function but are not
considered clinical measures of optical quality.
Optically, high contrast Snellen acuity is the limiting
resolution of the eye. Although standard visual acuity test-
ing involves recognition, which is more complex than
simple resolution, it is still considered the limiting resolu-
tion of the eye in clinical terms. Wavefront devices objec-
tively measure the quality of the wavefront entering (ie,
patient’s view) or leaving (ie, measurement view) the eye.
The difference from the perfect spherical wavefront is a
measure of the quality of the optical system. The data from
the wavefront can be transformed into point spread func-
38 Chapter 5

Figure 5-1. The cornea is prolate with an average Q-value in the

population of ~0.26 (reprinted from J Cataract Refract Surg,
25(5), Holladay JT, Dudeja DR, Chang J, Functional vision and Figure 5-2. The crystalline lens has a negative spherical
corneal changes after laser in situ keratomileusis determined by
aberration in the young that is almost equal and opposite
contrast sensitivity, glare testing, and corneal topography, pp.
663-669, with permission from the American Society of Cataract to the remaining positive spherical aberration in the
and Refractive Surgery and The European Society of Cataract and cornea.
Refractive Surgery).

Figure 5-4. The older eye has significant spherical aberra-

tion.
Figure 5-3. The young eye has almost no spherical aberra-
tion.
they are similar to standard acuity testing and easily under-
stood by the patient. The letters have higher order spatial
tion (PSF) and modulation transfer function (MTF), which
frequencies (the corners of the letters) and require “recog-
are used to describe the quality of any optical system, such
nition” of the letter, which complicates the idea of thresh-
as cameras, microscopes, and telescopes.
old detection. Snellen visual acuity and contrast sensitivi-
Contrast sensitivity is a subjective measure of the
ty are the main subjective measurement outcomes of the
patient’s visual system. This test actually determines the
entire visual system (optical and sensory), and wavefront
“threshold” of the lowest contrast optotype that can be
the objective measure of the optical component of the
detected. The size of the optotype (spatial frequency) is
visual system.
usually described in degrees so it can be related to a visual
angle. Testing may be done with any optotype, but the
primary tests that have been used historically are low con- OPTICAL QUALITY OF
trast letters and sinusoidal gratings. The scientist prefers
the sinusoidal gratings because it is a pure frequency and it
PHAKIC INTRAOCULAR LENSES
is easy to make transformations and perform analyses. The Phakic intraocular lenses (IOLs) are implanted in three
low contrast letters are preferred by clinicians because locations: anterior chamber angle, iris supported, and poste-
 Optics and Intraocular Lens Power Calculations for Phakic Intraocular Lenses
rior chamber. The primary problem with the slow accept-
ance of phakic lenses into the refractive market is related to
the surgical complications rather than any optical problems.
The angle- and iris-supported lenses have the same
problems as lenses supported by uveal tissue (ie, iritis,
glaucoma, and ovalization of the pupil). Optical problems
with these two lenses have been related to the size of the
optic. When the optic is less than 5.0 mm in diameter,
many patients complain of glare. When the lens is larger
than 6.0 mm, endothelial cell loss becomes a problem. For
patients with 5.5 mm pupils or less, these lenses provide
good optical quality when they are well-centered and not
tilted. For patients with larger pupils, light travels around
the lens and through the pupil, causing secondary images
and edge glare. If the lenses are tilted or decentered, astig-
matism and coma aberrations are induced into the optical
system, reducing visual performance.
Phakic IOLs in the posterior chamber (ie, intraocular
contact lens [ICL] and phakic refractive lens [PRL]) are
optically excellent, but surgical problems, such as pupillary
block, anterior subcapsular cataract, and pigmentary dis-
persion, have prevented wide-spread use. If none of these
surgical problems arise, high contrast visual acuity, con-
trast sensitivity, and wavefront analysis remain virtually
unchanged after implantation, except for induced spheri-
cal aberration when the surfaces are spherical. In the near
future, modified prolate aspheric phakic IOLs will be avail-
able, reducing or eliminating the induced and preoperative
spherical aberration of the eye.20,21
PHAKIC INTRAOCULAR
LENSES AS AN ALTERNATIVE
TO K ERATOREFRACTIVE S URGERY
Phakic IOLs provide an attractive alternative to kera-
torefractive surgery, particularly for larger refractive errors
(>12 diopters [D]). The only common, presently used ker-
atorefractive procedure that can achieve corrections at or
above this range is laser in-situ keratomileusis (LASIK).
The optical quality of the vision in these high myopic
cases has been less than desirable. The primary reason for
the marginal optical performance is due to the small opti-
cal zone, extreme oblate aspheric shape, and microirregu-
larities (increase root mean square [RMS] surface values)
that occur following the procedure.
Although improvements with scanning lasers, custom
ablations, and improved algorithms for reshaping the
cornea will certainly improve these results, the physical
limitations of corneal thickness prevent this procedure
from ever reshaping the cornea to the original prolate
aspheric shape with the original optical zone and surface
regularity. Because of this physical barrier for LASIK, pha-
kic IOLs offer an attractive alternative.
39
Phakic IOLs have several advantages. They do not
change the characteristics of the normal cornea and offer
the potential of maintaining or possibly improving the
optics of the eye. Because the phakic IOLs are nearer the
pupil, the optical zones can be proportionately smaller than
corresponding corneal treatments to obtain the same effec-
tive optical zone. The smooth surfaces of phakic IOLs are
well above the optical limit of the eye and, therefore, pro-
vide no reduction in the RMS (surface regularity) optical
quality of the retinal image, unlike the microirregularities
induced in the cornea by LASIK. Furthermore, the proce-
dure is reversible by removing or exchanging the lens.
As with any procedure, there are always tradeoffs. For
phakic IOLs the disadvantages include the risk of an
intraocular procedure with endothelial cell loss; possible
infection; and contact with the crystalline lens, causing a
cataract. Although removal and exchange are possible, it
re-exposes the patient to another intraocular procedure
and all of the risks associated with the procedure. Anterior
chamber phakic IOLs contact uveal tissue and have the
potential of inducing chronic iritis; pupillary distortion;
endothelial cell loss; secondary glaucoma; and related pos-
terior changes, such as cystoid macular edema. Posterior
chamber phakic IOLs (ie, ICLs) do not contact uveal tis-
sue, but may contact the anterior crystalline lens, which
can cause a cataract. When the lens is vaulted properly
over the crystalline lens, it may contact the posterior iris,
causing pigment dispersion, transillumination defects in
the iris, and pigmentary glaucoma. A larger vault can be
created by increasing the diameter to avoid contact with
the crystalline lens, but it may cause chaffing of the
zonules, ciliary processes, or the sulcus, which may lead to
a pseudoexfoliation syndrome or uveitis. ICLs may also
lead to a pupillary block if the peripheral iridectomies are
not patent or absent, which can lead to extremely high
pressure and result in the same damage to the eye as an
acute narrow angle attack: “blown” pupil and ischemia of
the optic nerve and retina, causing blindness.
Because phakic IOL complications have been extreme-
ly rare and the quality of the optics of the eye are pre-
served, increasing numbers of phakic IOLs are being
implanted throughout the world. Understanding the clin-
ical and theoretical basis for IOL power calculations in
these cases is extremely important.
NECESSARY MEASUREMENTS
FOR P HAKIC AND
PSEUDOPHAKIC INTRAOCULAR
LENS CALCULATION FORMULAS
Several measurements of the eye are helpful in deter-
mining the appropriate IOL power to achieve a desired
refraction. These measurements include central corneal
40 Chapter 5
Table 5-1
CLINICAL CONDITIONS DEMONSTRATING THE
INDEPENDENCE OF THE ANTERIOR SEGMENT AND AXIAL LENGTH
Anterior Segment Size
Short
Small Small eye
Nanophthalmos
Normal Axial hyperopia
Large Megalocornea
Axial hyperopia
refractive power (ie, k-readings), axial length (ie, biome-
try), horizontal corneal diameter (ie, horizontal white-to-
white measurement), anterior chamber depth, lens thick-
ness, preoperative refraction, and age. The accuracy of
predicting the necessary power of an IOL is directly relat-
ed to the accuracy of these measurements.22,23 The more
unusual the eye, the greater the requirement for these
additional measurements.
Fyodorov first estimated the optical power of an IOL
using vergence formulas in 1967.24 Between 1972 and
1975, when accurate ultrasonic A-scan units became com-
mercially available, several investigators derived and pub-
lished the theoretical vergence formula.25-30 All of these
formulas were identical31 except for the form in which
they were written and the choice of various constants,
such as retinal thickness, optical plane of the cornea, and
optical plane of the IOL. These slightly different constants
accounted for less than 0.50 D in the predicted refraction.
The variation in these constants was a result of differences
in lens styles, A-scan units, keratometers, and surgical
techniques among the investigators.
In 1995, Olsen et al published a four variable predictor
that used axial length, keratometry, preoperative anterior
chamber depth, and lens thickness.32 His results did show
improvement over the current two variable prediction for-
mulas. The explanation is very simple: The more informa-
tion we have about the anterior segment, the better we can
Axial Length
Normal Long
Microcornea Microcornea
Axial myopia
Normal Axial myopia
Megalocornea Large eye
Buphthalmos
Axial myopia
predict the effective lens position (ELP). This explanation
is a well-known theorem in prediction theory in which the
more variables that can be measured describing an event,
the more precisely one can predict the outcome.
A recent study33 discovered that the anterior segment
and posterior segment of the human eye are often not pro-
portional in size, causing significant error in the prediction
of the ELP in extremely short eyes (<20 mm). We found
that even in eyes shorter than 20 mm, the anterior segment
was completely normal in the majority of cases. Because
the axial lengths were so short, the two variable prediction
formulas severely underestimated the ELP, explaining part
of the large hyperopic prediction errors with current two
variable prediction formulas. After recognizing this prob-
lem, we began to take additional measurements on
extremely short and extremely long eyes to determine if
the prediction of ELP could be improved by knowing
more about the anterior segment. Table 5-1 shows the
clinical conditions that illustrate the independence of the
anterior segment and the axial length.
Although several additional measurements of the eye
can be taken, it is our opinion that only seven preoperative
variables (ie, axial length, corneal power, horizontal
corneal diameter, anterior chamber depth, lens thickness,
preoperative refraction, and age) have been found to be
useful for significantly improving the prediction of ELP in
eyes ranging from 15 to 35 mm.
 Optics and Intraocular Lens Power Calculations for Phakic Intraocular Lenses
PHAKIC INTRAOCULAR LENS
POWER CALCULATION FORMULA
Formula and Rationale for
Using Preoperative Refraction
In a standard cataract removal with IOL implantation,
the preoperative refraction is not very helpful in calculat-
ing the power of the implant because the crystalline lens
will be removed so dioptric power is being removed and
then replaced. In cases in which no power is being
removed from the eye, such as secondary implant in
aphakia, piggy-back IOL in pseudophakia, or a minus IOL
in the anterior chamber of a phakic patient, the necessary
IOL power for a desired postoperative refraction can be
calculated from the corneal power and preoperative refrac-
tion; the axial length is not necessary. The formula for cal-
culating the necessary IOL power is given below.34
Definition of Variables:
ELP = expected lens position in mm (distance from
corneal vertex to principal plane of intraocular lens)
IOL = intraocular lens power in D
Kref = net corneal power in diopters (0.996885 x
Kkeratometric)
PreRx = preoperative refraction in D
DPostRx = desired postoperative refraction in D
V = vertex distance in mm of refraction
The standardized 72-year-old phakic schematic eye is
shown in Figure 5-3. Although axial length, horizontal
corneal diameter, anatomic anterior chamber depth, lens
thickness, and age do not appear in the primary formula,
they are implicit in that they are used in the calculation of
the phakic ELP and would be referred to as secondary vari-
ables. These secondary variables, along with the primary,
are valuable in predicting the “vault” and final position of
phakic lenses in the eye.
Cases Calculated From
Preoperative Refraction
As mentioned above, the appropriate cases for using the
preoperative refraction and corneal power include a minus
anterior (ACL) or posterior chamber (ICL) IOL in a high
myopic phakic patient, secondary piggy-back IOL in
pseudophakia, and secondary implant in aphakia. In each
of these cases no dioptric power is being removed from the
41
eye, so the problem is simply to find the IOL at a given
distance behind the cornea (ELP) that is equivalent to the
spectacle lens at a given vertex distance in front of the
cornea. If emmetropia is not desired, then an additional
term, the desired postoperative refraction (DPostRx), must
be included. The formulas for calculating the predicted
refraction and the back-calculation of the effective lens
position (ELP) are given in the reference and will not be
repeated here.34
Example: Primary Minus Intraocular
Lens in a High Myopic Phakic Patient
The calculation of a phakic IOLs in the anterior cham-
ber is no different than the aphakic calculation of an ante-
rior chamber lens, except the power of the lens is usually
negative. In the past, these lenses have been reserved for
high myopia that could not be corrected by radial kerato-
tomy (RK), photorefractive keratectomy (PRK), or LASIK.
Because most of these lenses fixate in the anterior chamber
angle, concerns of iritis and glaucoma have been raised.
Nevertheless, several successful cases have been performed
with good refractive results. Because successful LASIK
procedures have been performed in myopia up to ~ -12.00
D, phakic IOLs are usually reserved for myopia exceeding
this power. Interestingly, the power of the negative ante-
rior and posterior chamber implant is very close to 100%
of the spectacle refraction for normal vertex distances (12
to 14 mm).
Mean keratometric corneal power (Kkeratometric) =
45.00 D
Phakic refraction (PreRx)= -20.00 sphere @ vertex
(V) of 14 mm
Manufacturers anterior chamber depth (ACD) lens
constant (ELP) = 3.50 mm
Desired postoperative refraction (DPostRx) = -0.50 D
Using an ELP of 3.50 and modifying the K-reading to
net corneal power yields a -18.49 D powered IOL for a
desired refraction of -0.50 D. If a -19.00 D lens is used, the
patient would have a predicted postoperative refraction of
-0.10 D. The -19.00 D IOL is very near the power of the
original spectacle refraction of -20.00 D.
Example: Primary Plus Intraocular Lens in a
High Hyperopic Phakic Patient
The calculation of a plus phakic IOL in the anterior
chamber is no different than the minus calculation of an
anterior chamber lens, except the result is usually closer to
150% of the original refraction at the spectacle plane,
rather than near 100% for the minus lens. The explanation
relates to the vertexing of minus and plus lenses. When a
minus lens is vertexed from the spectacle plane to the
corneal plane, the power becomes less in magnitude (eg,
-20.00 D @ spectacle to -15.00 D @ corneal plane). When
42 Chapter 5
Figure 5-5. No significant surprises have occurred in the back-
calculated constants for the phakic anterior chamber IOLs in
that the lens constants are no different than those obtained with
secondary anterior chamber implants in aphakia or
pseudophakia.
vertexing through the cornea to the ELP, the power must
increase deeper in the anterior chamber (eg,
-15.00 D @ cornea to -20.00 D @ the ELP). When a plus
lens is vertexed from the spectacle plane to the corneal
plane, the power must increase in magnitude (eg, +10.00
D @ spectacle to +12.50 D @ corneal plane) and then
must increase again when vertexed through the cornea (eg,
+12.50 @ corneal plane to +15.00 @ ELP). The result is
that plus phakic IOLs are near 150% of the spectacle
power for normal vertex distances (12 to 14 mm).
Mean keratometric corneal power (Kkeratometric) =
45.00 D
Phakic refraction (PreRx)= +10.00 sphere @ vertex
(V) of 14 mm
Manufacturers ACD lens constant (ELP) = 3.68 mm
Desired postoperative refraction (DPostRx) = -0.50 D
Using an ELP of 3.68 and modifying the K-reading to
net corneal power yields a +17.30 D powered IOL for a
desired refraction of -0.50 D. If a +17.50 D lens is used,
the patient would have a predicted postoperative refrac-
tion of -0.65 D.
CLINICAL RESULTS
We have had the opportunity to evaluate several data
sets for both anterior and posterior chamber IOLs. No sig-
nificant surprises have occurred in the back-calculated
constants for the phakic anterior chamber IOLs in that the
lens constants are no different than those obtained with
secondary anterior chamber implants in aphakia or
pseudophakia (Figure 5-5). The accuracy of the predicted
refractions are very similar to standard IOL calculations
from axial length, with more than 50% of the cases result-
ing in a refraction that is within ± 0.50 D. The number of
cases with greater than a 2 D prediction error are virtually
zero, as with calculations from axial length.
ICLs are different. Unlike anterior chamber phakic
IOLs that have primarily biconcave optics, ICLs can be
both biconcave and meniscus in shape like contact lenses
(see Figure 5-5). The current predictive accuracy of these
lenses is less than anterior chamber phakic IOLs. The
exact reasons are unknown at this time, but most include
parameters such as the meniscus shape, new index of
refraction, possible interaction with the power of the ante-
rior crystalline lens, and variation in the lens power from
room temperature (21°C) to anterior chamber eye temper-
ature (35°C).
In all of the data sets we have analyzed, the ICLs appear
to consistently perform with 25% to 33% less effective
power than the labeled power (ie, a lens labeled -20 D per-
forms as if its power were -15 D). Although there are many
plausible explanations for this finding, as mentioned
above, the exact cause is unknown at this time and the
labeling issue is unique to this manufacturer.
Whatever the cause of the mislabeled power, back-cal-
culated constants for the ICLs, using the phakic IOL for-
mula above results in lens constant ELPs that are 5.47 mm
to 13.86 mm (mean value ~9.0 mm), even though the aver-
age measured ELP is 3.6 mm. In the data sets that we have
analyzed, when the optimized back-calculated ELP is
used, the mean absolute error is approximately 0.67 D,
indicating that 50% of the cases are within ± 0.67 D. This
value is higher than the ± 0.50 D typically found with
standard IOL calculations following cataract surgery. The
ICLs should be better than ACLs since the exact location
of the lens can be predicted from the anatomic anterior
chamber depth preoperatively. This difference is puzzling,
not only because of the better prediction of the ELP but
also because any errors in the measurement of the axial
length are irrelevant because it is not used in the phakic
IOL formula. Because of the labeling issue with ICLs,
power calculations should be confirmed with the company
or some other reliable source familiar with this problem.
BIOPTICS (LASER IN-SITU
KERATOMILEUSIS AND ACL
OR I MPLANTABLE C ONTACT L ENS )
When patients have greater than 15 D of myopia, a
combination of LASIK and phakic IOLs have been used to
correct these large refractive errors. Pioneered by Roberto
Zaldivar, the procedure has results that are remarkably
good. The surgeon performs the phakic IOL as the first
stage, leaving the patient with low compound myopic
astigmatism. Then LASIK or PRK is performed to correct
 Optics and Intraocular Lens Power Calculations for Phakic Intraocular Lenses
the residual sphere and astigmatism. These patients are
especially grateful because glasses and contact lenses do
not provide adequate correction and the tremendous mini-
fication of these corrections causes a significant reduction
in preoperative visual acuity. Changing a 20 D myopic
patient from spectacles to emmetropia with a phakic IOL
and LASIK or PRK can increase the image size by approx-
imately 50%. This would improve the visual acuity by two
lines due to magnification alone (one line improvement in
visual acuity for each 25% increase in magnification).
In contrast, phakic IOLs for hyperopia result in minifica-
tion compared to spectacles and would have the reverse
affect. However, problems with “ring scotoma,” “jack-in-the-
box phenomenon,” and pincushion distortion with high plus
spectacles are much worse than the loss of magnification.
CONCLUSIONS
Phakic IOLs are still in their adolescence. Power label-
ing issues and temperature dependent index of refractions,
changes in the meniscus shape, and actual lens locations
are being experimentally evaluated and are similar to the
evolution of IOLs used following cataract surgery in the
early 1980s. There is no question that our ability to predict
the necessary phakic IOL power to correct ametropia will
improve, possibly exceeding the results with standard
IOLs as they should because of the more accurate predic-
tion of the lens location axially. Determining the optimal
vaulting and overall diameter to minimize crystalline lens
contact, posterior iris contact and zonular, ciliary process-
es or sulcus contact are all being investigated for ICLs at
this time. These refinements are no different than the evo-
lution in location from the iris, to the sulcus, and, finally,
the bag for standard IOLs. Because of our improved
instrumentation with high resolution A- and B-scans, con-
focal microscopes, and anterior segment laser imaging and
slit scanning systems, these refinements should and will
occur much more rapidly. The use of phakic IOLs will
become more widespread as the current problems are
solved and will begin to cause a decline in the percentage
of patients who have LASIK because of the potential for
better overall optical performance of the eye.
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Standards for reporting the optical aberrations of eyes.
Vision Science and its Applications: OSA Trends in Optics
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2. Howland HC, Howland B. A subjective method for the
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3. Walsh G, Charman WN. Measurement of the axial wave-
front aberration of the human eye. Ophthalmic Physiol
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43
4. Liang J, Grimm B, Goelz S, Bille JF. Objective measurement
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5. Guirao A, Artal P. Corneal wave aberration from videoker-
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6. Wang JY, Silva DE. Wave-front interpretation with Zernike
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7. Artal P, Berrio E, Guirao A, Piers P. Contribution of the
cornea and internal surfaces to the change of ocular aberra-
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8. Oshika, T, Klyce SD, Applegate RA, Howland HC.
Changes in corneal wavefront aberrations with aging. Invest
Ophthalmol Vis Sci. 1999;40:1351-1355.
9. Glasser A, Campbell MC. Biometric, optical and physical
changes in the isolated human crystalline lens with age in
relation to presbyopia. Vision Res. 1999;39:1991-2015.
10. Smith G, Atchison DA, Pierscionek BK. Modeling the
power of the aging eye. J Opt Soc Am A. 1992;9:2111-
2117.
11. Guirao A, Gonzalez C, Redondo M, et al. Average optical
performance of the human eye as a function of age in a nor-
mal population. Invest Ophthalmol Vis Sci. 1999;40:203-
213.
12. Nio YK, Jansonius NM, Fidler V, et al. Age-related changes
of defocus-specific contrast sensitivity in healthy subjects.
Ophthalmic Physiol Opt. 2000;20:323-334.
13. McLellan JS, Marcos S, Burns SA. Age-related changes in
monochromatic wave aberrations of the human eye. Invest
Ophthalmol Vis Sci. 2001;42:1390-1395.
14. El Hage SG, Berny F. Contribution of the crystalline lens to
the spherical aberration of the eye. J Opt Soc Am.
1973;63:205-211.
15. Artal P, Guirao A, Berrio E, Williams D. Compensation of
corneal aberrations by the internal optics in the human eye.
Journal of Vision. 2001;1:1-8.
16. Smith G, Cox MJ, Calver R, Garner LF. The spherical aber-
ration of the crystalline lens of the human eye. Vision Res.
2001;41:235-243.
17. Dubbelman M, Van der Heijde GL. The shape of the aging
human lens: curvature, equivalent refractive index and the
lens paradox. Vision Res. 2001;41:1867-1877.
18. Glasser A, Campbell MC. Presbyopia and the optical
changes in the human crystalline lens with age. Vision Res.
1998;38:209-229.
19. Kiely PM, Smith G, Carney LG. The mean shape of the
human cornea. Optica Acta. 1982;29:1027-1040.
20. Holladay JT, Piers PA, Koranyi G, van der Mooren M,
Norrby NE. A new intraocular lens design to reduce spher-
ical aberration of pseudophakic eyes. J Refract Surg.
2002;18:683-691.
21. Packer M, Fine IH, Hoffman RS, Piers, PA. Prospective ran-
domized trial of an anterior surface modified prolate
intraocular lens. J Refract Surg. 2002;18:692-696.
44 Chapter 5
22. Holladay JT, Prager TC, Ruiz RS, Lewis JL. Improving the
predictability of intraocular lens calculations. Arch
Ophthalmol. 1986;104:539-541.
23. Holladay JT, Prager TC, Chandler TY, Musgrove KH,
Lewis JW, Ruiz RS. A three-part system for refining intraoc-
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1988;13:17-24.
24. Fyodorov SN, Kolinko AI, Kolinko AI. Estimation of opti-
cal power of the intraocular lens. Vestn Oftalmol.
1967;80:27-31.
25. Fyodorov SN, Galin MA, Linksz A. A calculation of the
optical power of intraocular lenses. Invest Ophthalmol.
1975;14:625-628.
26. Binkhorst CD. Power of the prepupillary pseudophakos. Br
J Ophthalmol. 1972;56:332-337.
27. Colenbrander MC. Calculation of the power of an iris clip
lens for distant vision. Br J Ophthalmol. 1973;57:735-740.
28. Binkhorst RD. The optical design of intraocular lens
implants. Ophthalmic Surg. 1975;6:17-31.
29. van der Heijde GL. The optical correction of unilateral
aphakia. Trans Am Acad Ophthalmol Otolaryngol.
1976;81:80-88.
30. Thijssen JM. The emmetropic and the iseikonic implant
lens: computer calculation of the refractive power and its
accuracy. Ophthalmologica. 1975;171:467-486.
31. Fritz KJ. Intraocular lens power formulas. Am J Ophthalmol.
1981;91:414-415.
32. Olsen T, Corydon L, Gimbel H. Intraocular lens power cal-
culation with an improved anterior chamber depth predic-
tion algorithm. J Cataract Refract Surg. 1995;21:313-319.
33. Holladay JT, Gills JP, Leidlein J, Cherchio M. Achieving
emmetropia in extremely short eyes with two piggy-back
posterior chamber intraocular lenses. Ophthalmology.
1996;103:1118-1123.
34. Holladay, JT. Refractive power calculations for intraocular
lenses in the phakic eye. Am J Ophthalmol. 1993;116:63-
66.

Anesthesia for
Phakic Intraocular Lenses
Nicole J. Anderson, MD and C. Joseph Anderson, MD
INTRODUCTION
Various techniques have evolved to improve the safety
and efficacy of ocular anesthesia since its introduction in
the late 1800s. General anesthesia and orbital blocks were
the preferred methods of ocular anesthesia for most of the
20th century. However, with the advent of clear corneal
phacoemulsification, surgical times have decreased, inci-
sions have become smaller, and techniques have become
more efficient. As a result, many surgeons now prefer top-
ical anesthesia with or without intracameral lidocaine. The
choice of anesthesia for an individual patient is determined
by many factors, including the health of the patient,
length of the eye, type of surgery, and surgical technique.
Phakic intraocular lenses (IOLs) were introduced in the
1950s, but were largely abandoned because of a high com-
plication rate, most significantly corneal endothelial dam-
age.1,2 Several modifications and improvements of lens
designs ensued, resulting in a renewed interest in this
modality of refractive correction.
Surgical techniques for the implantation of phakic IOLs
most closely resemble techniques used for modern day
cataract surgery. As a result, anesthetic techniques are vir-
tually identical. There is no evidence to support one tech-
nique over the other for the implantation of phakic IOLs.
In fact, all current anesthesia techniques used for phakic
IOLs are based on studies in patients undergoing cataract
extraction. However, there are many differences between
cataract patients and those electing to undergo phakic IOL
implantation. In general, phakic IOL patients are young
and healthy. Heart disease, diabetes, hypertension, and
6
Chapter
chronic obstructive pulmonary disease may not be as
much of a concern in phakic IOL patients as it is in more
elderly patients undergoing cataract surgery. In addition,
this young population typically does not have coexisting
conditions that may make local or topical anesthesia
unsafe, such as hearing difficulties, impaired mental status,
and involuntary movements. However, it should also be
remembered that younger patients undergoing elective
surgery may be more anxious than older patients and may
therefore require more sedation.
The choice of anesthesia for phakic IOL correction will
depend somewhat on the lens and incision site. Foldable
phakic IOLs, such as the Implantable Contact Lens (ICL)
(STAAR Surgical, Monrovia, Calif) and the Phakic
Refractive Lens (PRL) (Medennium, Inc/CIBA Vision,
Atlanta, Ga), can be inserted through a clear corneal inci-
sion because of their smaller size. This lends itself to the
use of topical anesthesia. However, these lenses have been
inserted using a variety of techniques, including topical
lidocaine, lidocaine gel, regional blocks, and general anes-
thesia.3-5
Angle-supported phakic IOLs, such as the Baïkoff
NuVita MA20 (Bausch & Lomb Surgical, Rochester, NY),
may be more effectively inserted using retrobulbar and
peribulbar techniques rather than topical anesthesia. A
larger incision is necessary to insert the nonfoldable vari-
eties, and iris manipulation is common during the inser-
tion. Regional blocks were used in most of the published
clinical studies of angle-supported lenses.6-8
The Artisan phakic IOL (Ophtec USA Inc/Allergan,
Boca Raton, Fla) requires a large (6.5 mm) incision. Several
48 Chapter 6
incision types have been used, including clear cornea, cor-
neoscleral, limbal, or scleral tunnel. In addition, the
Artisan lens requires iris manipulation when enclavating
the lens. Therefore, topical anesthesia alone may not be
adequate. However, topical anesthesia combined with
intracameral lidocaine has been used successfully,9 even
though the safety of this technique in phakic patients has
not been studied. Depending on patient needs and sur-
geon preference, other anesthesia techniques used in the
series of Artisan patients published to date have included
general, retrobulbar, and peribulbar blocks.10,11
TOPICAL/INTRACAMERAL
History
The first topical anesthetic used for ocular surgery was
cocaine, extracted from Erythroxylon coca. Koller
described the use of topical cocaine for ocular surgery in
1884.12 In that same year, Knapp reported a technique for
cataract removal under topical anesthesia using frequent
instillation of cocaine.13 His technique was largely aban-
doned secondary to local toxicity (exposure keratopathy
and corneal ulceration) and complications associated with
the retrobulbar use of cocaine. Since that time, less toxic
anesthetics have become available. Common topical
agents used today include benoxinate 0.4%, tetracaine
0.5%, and proparacaine 0.5%.
Fichman was the first to report the successful use of
topical anesthesia in modern day cataract surgery.14 In
1995, Gills reported the use of intracameral lidocaine as an
adjunct to topical anesthesia.15 Many studies in the past
decade have found the intracameral administration of lido-
caine to be a safe and effective method of providing addi-
tional pain control during cataract surgery.15-17
Description/Technique
Topical anesthesia aims to block the superficial branch-
es of the nasociliary and lacrimal nerves to the cornea and
conjunctiva. There is minimal intraocular penetration of
the anesthesia; therefore, intraocular sensations, such as
increased intraocular pressure, anterior chamber irrigation,
and iris manipulation, may be felt by the patient. These
sensations can be minimized by the use of intracameral
lidocaine. The addition of lidocaine to the anterior cham-
ber allows the anesthetic to diffuse into the iris stroma and
be absorbed by the unmyelinated small sensory nerve fibers
of the long and short posterior ciliary nerves. Lidocaine is
taken up quickly by the iris/ciliary body and cornea and is
rapidly removed upon washout with balanced salt solu-
tion.18
The technique of topical anesthesia requires the place-
ment of several drops of an anesthetic agent on the eye
shortly before surgery. The number and timing of admin-
istration varies according to surgeon preference. In gener-
al, however, there are two reasons to administer the anes-
thetic shortly before surgery. First, topical agents have a
short half-life and the anesthetic effect may wear off
before the conclusion of surgery. Second, unnecessary
application of drops given long before the procedure com-
mences may increase the risk of epithelial toxicity. Some
surgeons prefer to use topical lidocaine, noticing reduced
epithelial toxicity and increased duration of action as com-
pared to tetracaine, benoxinate, or proparacaine.19,20 The
drops can be placed directly on the surface of the eye or
soaked in the anesthetic agent and placed in the conjunc-
tival cul-de-sac in the preoperative period. Alternatively,
2% lidocaine gel can be used and has the benefit of acting
as a lubricating agent.16,21
If intracameral anesthesia is used, typically 0.2 to 0.5
mL of unpreserved (methylparaben-free) 1% lidocaine
hydrochloride is injected into the anterior chamber imme-
diately after the paracentesis incision and before viscoelas-
tic injection.15
Advantages/Disadvantages
The benefits of topical anesthesia include immediate
onset of action, short duration, early return of visual acu-
ity, and preservation of full ocular motility with good post-
operative cosmesis. A patch is not required (most benefi-
cial in monocular patients) and periocular bruising from an
injection does not occur. In addition, there are no needle-
associated risks, such as globe perforation or hemorrhage.
Therefore, it is a preferable method of anesthesia in
patients on systemic anticoagulation medication.
However, there are shortcomings to the topical admin-
istration of anesthesia. For example, the patient is awake
with no akinesia. This may not be an ideal surgical cir-
cumstance for a nervous or anxious patient. In addition,
there may be inadequate blockade of sensory and motor
nerves in the iris/ciliary body from incomplete absorption
or dilution by tears. Therefore, patients may experience
intolerance to the operating light microscope, discomfort
from iris manipulation, and changes in pressure dynamics
inside the eye.22 A recent review of literature showed con-
vincing evidence that both retrobulbar and peribulbar
anesthesia provide better pain control during cataract sur-
gery than topical anesthesia alone.23
The introduction of intracameral lidocaine, however,
has minimized pain associated with topical anesthesia.23,24
Two studies revealed that no pain was experienced by
77% and 90% of patients undergoing cataract surgery with
intracameral lidocaine vs 47% and 74% in the topical
group alone.15,25 Even fewer patients may experience pain
with the addition of an intravenous sedative or narcotic.
However, patients should not be overly sedated, as their
cooperation is required throughout the surgical procedure.

In addition, the use of intravenous agents has been shown
in one study to increase the risk of medical events (eg,
myocardial infarction, ischemia, heart failure, arrhythmias,
hypertension, and hypotension).26 This study, however,
was conducted in patients undergoing cataract surgery
with an average age in the mid-70s.
Topical anesthesia with or without intracameral lido-
caine requires constant communication between the sur-
geon and the patient. Surgeons or patients who are not
good communicators are not ideal for topical anesthesia.
Additionally, language barriers, movement disorders, or
deafness may preclude the use of topical anesthesia.
Patients with nystagmus and large angle strabismus also
are not good candidates for topical anesthesia because of
fixation difficulties.
Complications
Complications of topical anesthetics for ocular surgery
are mainly superficial, including epithelial keratopathy and
alteration of the tear film.20 The addition of intracameral
lidocaine has been shown in several studies to be well tol-
erated by the cornea.17 Corneal toxicity in rabbits has
been demonstrated with the use of intracameral bupiva-
caine probably because of a higher lipid solubility than
lidocaine27,28; however, corneal toxicity was not found
with the clinical use of intracameral bupivacaine.27
Intracameral lidocaine has been associated with transient
corneal edema29 and transient dose dependent retinal
changes.17 There is one report of no light perception visu-
al acuity after intracameral injection of lidocaine with full
visual recovery.30
ORBITAL BLOCKS
Retrobulbar
History
Retrobulbar blocks using 4% retrobulbar cocaine for
enucleation were first described by Knapp in 1884.13
Cocaine was largely abandoned due to episodes of syn-
cope, excessive stimulation, hallucinations, and even
death. Procaine hydrochloride was introduced in 1905
when it was discovered that it could be used for nerve
blocks without the effects of cocaine. It wasn’t until the
1930s, however, that retrobulbar injection of procaine
became popular.31 Subsequently, other amide anesthetics,
principally lidocaine, were introduced and are now used
more frequently due to better diffusion and a longer dura-
tion of action than procaine. The addition of
hyaluronidase was found to further increase anesthetic dif-
fusion and improve the rapidity of onset.32
Anesthesia for Phakic Intraocular Lenses 49
Although the classic technique of retrobulbar injections
was described by Atkinson,33 there have been many varia-
tions reported since his original description. These varia-
tions include multi-injection techniques; changes in gaze
position; and altering needle design, sharpness, and
length.34,35
Description/Technique
In general, a sharp 25- or 27-gauge retrobulbar needle
is placed just above the infraorbital rim at the junction of
the lateral third and medial two-thirds of the orbital rim.
The needle can either be placed through the skin or the
skin can be pulled down and the needle injected subcon-
junctivally in the lower fornix. An index finger is used to
elevate the globe out of the path of the needle. The nee-
dle is passed parallel to the floor of the orbit until the tip
of the needle is past the equator of the globe (1.5 cm) or
until the midshaft of the needle has reached the plane of
the iris.36 The needle is then directed superiorly and medi-
ally toward the intraconal space, aiming for an imaginary
point behind the macula. This technique also aims to min-
imize the risk of inadvertently damaging the inferior
oblique muscle. Three “pops” should be heard as the nee-
dle penetrates the skin, orbital septum, and intraconal
space. After aspiration, 3 to 5 mL of the anesthetic agent
is slowly injected. This may be followed by lid ptosis,
pupil dilation, akinesia, and amaurosis. A Honan balloon
(Katena Products Inc, Denville, NJ), or other external
pressure, is typically applied to the eye for at least 15 min-
utes.
In Atkinson’s original description of the retrobulbar
technique, patient gaze was superior and medial.33
However, it was later discovered that this position rotates
the optic nerve, ophthalmic artery, superior orbital vein,
and posterior pole of the globe into the path of the needle
(Figure 6-1A).37,38 The optic nerve is also stretched in this
position, which increases the chance of perforating the
nerve. Therefore, primary gaze is the currently recom-
mended eye position during administration of a retrobul-
bar block so that the optic nerve is directed away from the
path of the needle (Figure 6-1B).37 The type of needle is
also important in minimizing the risk of globe perforation,
with shorter (31 mm) needles being safer than longer (38
to 40 mm) needles.39
Common anesthetic agents for retrobulbar and peribul-
bar blocks are lidocaine 1% to 2%, bupivacaine 0.25% to
0.75%, etidocaine 0.5% to 1%, and mepivacaine 1% to
2%. A combination of these agents may be used to maxi-
mize the rapidity of onset and duration of anesthesia. For
example, lidocaine has a rapid onset of action and rela-
tively short duration. Bupivacaine has a longer duration of
action, but slower onset than lidocaine. Therefore,
depending on the anticipated length of surgery, any com-
bination of agents may be used.
50 Chapter 6
Figure 6-1. Retrobulbar block. Atkinson's original description
with the globe position up and in before the needle is advanced
parallel to the floor of the orbit. In this position, the needle may
penetrate the optic nerve. The currently recommended tech-
nique is with the globe in primary position prior to advancement
of the needle. The optic nerve is further from the course of the
needle (reprinted from Lindquist TD, Lindstrom RL. Ophthalmic
Surgery: Looseleaf and Update Series: Anesthesia in Ocular
Surgery. Orlando, Fla: Elsevier Science; 1990:IA7, with permis-
sion from Elsevier Science).
Hyaluronidase enhances the ability of a local anesthet-
ic to spread through the orbital tissues. Therefore, the
addition of 1.0 mL of hyaluronidase per 10 mL of anesthe-
sia may reduce the time to onset of akinesia and anesthe-
sia. There is very poor evidence, however, that
hyaluronidase enhances the degree of akinesia pro-
duced.23 Some surgeons have tried warming or buffering
the anesthetic agents with sodium bicarbonate to reduce
pain on injection and to improve the effectiveness of anes-
thesia. However, these techniques have not in general
been found to be efficacious.23
The use of epinephrine in retrobulbar blocks is contro-
versial. On one hand, epinephrine retards the systemic
absorption of the anesthetic and, therefore, prolongs the
anesthetic effect. Epinephrine, however, is a vasoconstric-
tor and may affect the central retinal artery or ophthalmic
artery. Retrobulbar injection of lidocaine with epinephrine
has been shown to reduce ophthalmic artery pressure by
50%.40 Therefore, it may be contraindicated in patients
with poor circulation or poor optic nerve function.
Advantages/Disadvantages
Advantages of retrobulbar blocks include akinesia, reli-
ability of anesthetic effect, and improved pain control over
topical anesthesia.23 Compared to peribulbar blocks,
retrobulbar blocks are more reliable, have a quicker onset,
and are associated with less chemosis. Retrobulbar anes-
thesia, however, does not block the frontal and lacrimal
nerve branches that enter the orbit above the annulus of
Zinn. As a result, patients may still have sensation in struc-
tures innervated by these branches, such as the superior
and lateral conjunctiva and skin of the eyelid. Therefore,
patients may need a supplemental facial or eyelid block.
Complications
There are a variety of needle-associated complications
of retrobulbar blocks. These complications are important
considerations in patients undergoing phakic IOL implan-
tation because many of them are high myopes with long
eyes. The risk of globe perforation with retrobulbar and
peribulbar blocks is higher in eyes with longer axial
lengths.41,42 In a series of 20 eyes with globe perforation
following retrobulbar and peribulbar blocks, 45% had an
axial length greater than 26 mm.42
There are a host of complications of retrobulbar blocks
including, but not limited to, globe perforation, retrobul-
bar hemorrhage, retinal vascular occlusion, extraocular
muscle injury, ptosis, optic nerve damage, brainstem anes-
thesia from subarachnoid or intradural injection, and car-
diac and respiratory arrest.43-50
Peribulbar
History
Kelman introduced the technique of peribulbar anesthe-
sia for cataract surgery and it was later popularized in the
mid-1980s by Davis and Mandel.51 Their original descrip-
tion is of multiple injections at multiple sites in both the
anterior and posterior orbit. There have been many varia-
tions of the technique since their original description.
Description/Technique
Peribulbar blocks are administered in a similar fashion
as retrobulbar blocks. The site of injection is either the
standard juncture of the lateral third and medial two-thirds
of the infraorbital rim or midline, just superior to the rim
(Figure 6-2). The needle penetrates the orbital septum and
it is directed posteriorly along the floor of the orbit (Figure
6-3). The needle is not advanced superiorly and medially
as in a retrobulbar block; therefore, the muscle cone is not
entered and the agent is delivered to the extraconal
peribulbar space. A shorter 25- or 27-gauge needle (18 to
24 mm) can then be used. Higher volumes of anesthesia
(5 to 10 mL) are needed as compared to retrobulbar blocks
because this technique relies on the diffusion of the anes-
thetic through the orbital tissues. Following administration
of the block, pressure is applied to the eye with a Honan
balloon. If additional akinesia is needed (specifically to
block the superior oblique muscle), a medial periconal
injection can be administered in the supratrochlear region,
2 mm medial and inferior to the supraorbital notch.
Alternatively, the injection may be given between the
medial canthus and caruncle.

Figure 6-2. Peribulbar block. The standard inferior
approach places the needle just above the inferior orbital
rim through the skin. A wooden applicator or finger is
used to move the skin inferior and adjacent to the globe
(reprinted from Lindquist TD, Lindstrom RL. Ophthalmic
Surgery: Looseleaf and Update Series: Anesthesia in
Ocular Surgery. Orlando, Fla: Elsevier Science; 1990:IA8,
with permission from Elsevier Science).
Advantages/Disadvantages
An advantage of a peribulbar block is the improved reli-
ability of anesthesia and akinesia as compared to topical
anesthesia. Peribulbar blocks act on the long sensory root
of the ciliary ganglion; therefore, all of the trigeminal
nerve branches going to the globe are blocked.
Subsequently, there is often no need for a facial nerve
block. There may also be less needle-associated risks with
peribulbar anesthesia as compared to retrobulbar anesthe-
sia. In the peribulbar technique, the muscle cone is not
entered, so the sequelae of retrobulbar hemorrhage and
optic nerve compression are less likely and less severe.
There is also less intraoperative posterior pressure and less
intraoperative and postoperative amaurosis.52
Peribulbar blocks, however, take longer to achieve effi-
cacy, may require more than one injection, and cause sig-
nificant chemosis and ecchymosis.52 There is good evi-
dence that retrobulbar and peribulbar blocks provide equal
pain control and akinesia.23
Complications
Complications of peribulbar blocks are similar to those
of retrobulbar blocks and include globe perforation, hem-
orrhage, retinal vascular occlusion, extraocular muscle
injury, and brainstem anesthesia.46,53-56 However, the
incidence of direct injury to the optic nerve, globe perfo-
ration, and retrobulbar hemorrhage should be less since
the needle does not directly invade the muscle cone.
Anesthesia for Phakic Intraocular Lenses 51
Figure 6-3. Peribulbar block. The needle is directed posteriorly
along the floor of the orbit as the anesthesia is injected (reprint-
ed from Lindquist TD, Lindstrom RL. Ophthalmic Surgery:
Looseleaf and Update Series: Anesthesia in Ocular Surgery.
Orlando, Fla: Elsevier Science; 1990:IA8, with permission from
Elsevier Science).
Parabulbar/Sub-Tenon’s
History
Turnbull described injecting 4% cocaine into a cut
made through the conjunctiva and Tenon’s capsule before
enucleation in 1884.57 It wasn’t until the early 1990s, as
reports of complications of retrobulbar and peribulbar
blocks increased, that this technique underwent a resur-
gence.58,59
Technique
The conjunctiva is anesthetized using topical anesthe-
sia. Greenbaum’s classic technique consists of an incision
made 2 to 3 mm posterior to the limbus through the con-
junctiva and Tenon’s capsule.60 The administration site
chosen should be away from the rectus muscles to avoid
toxicity; the inferior quadrants are most commonly used.
The conjunctiva can be cauterized prior to the incision to
reduce subconjunctival hemorrhage. A polyethylene can-
nula (Greenbaum cannula [Alcon Labs Inc, Fort Worth,
Tex]) or a curved blunt cannula is then introduced into the
incision. The Greenbaum cannula is designed to encour-
age posterior dissection of the anesthetic along the globe
and minimize anterior fluid release. Approximately 1.0 to
1.5 mL of a lidocaine/bupivacaine mix is injected.
Alternatively, either agent alone could be used, depending
on the degree and length of anesthetic effect desired. To
be effective, the agent must diffuse to the posterior globe
near the optic nerve and anesthetize the posterior ciliary
52 Chapter 6

Figure 6-4. Sub-

Tenon's block. An
incision is made in the
conjunctiva with blunt
Westcott scissors (re-
printed from Lindquist
TD, Lindstrom RL.
Ophthalmic Surgery:
Looseleaf and Update
Series: Anesthesia in
Ocular Surgery. Or-
lando, Fla: Elsevier
Science; 1990:IA9,
with permission from
Elsevier Science).

nerves as they pass through Tenon’s capsule to penetrate
the sclera. Alternatively, an incision can be made more
posterior, through the conjunctiva and Tenon’s capsule,
and a curved, blunt, flattened tip cannula can be inserted
posteriorly behind the equator (Figures 6-4 and 6-5). If
only superficial anesthesia is needed, subconjunctival
injections have been used safely and efficaciously.61-63
More extensive anesthetic effect without akinesia is
obtained by circumferentially spreading subconjunctival
anesthetic around the globe.64,65
Advantages/Disadvantages
There are many advantages to parabulbar anesthesia as
compared to traditional orbital blocks. One advantage is
that the onset of anesthesia is immediate. Akinesia, how-
ever, may take approximately 5 minutes to achieve
because the motor axons are large caliber myelinated
nerves. The level of sensory blockade is better with a
parabulbar block than a retrobulbar block because all three
branches of the ophthalmic division of the trigeminal
nerve are addressed. Therefore, facial blocks are not need-
ed because patients do not perceive the sensory stimuli. In
addition, there is no significant increase in intraocular
pressure, which alleviates the need for ocular compression
after the injection. Furthermore, as compared to retrobul-
bar or peribulbar blocks, pain during administration and
during surgery is lessened.23 Finally, there are no needle-
related complications, such as globe perforation, because a
blunt probe is used for injection.
There are few disadvantages to a sub-Tenon’s
approach. It should be done under sterile conditions;
therefore, it is not well suited for the preoperative holding
area. Additionally, compared to topical anesthesia, an inci-
sion into the conjunctiva must be made. This may cause
patient discomfort and contribute to subconjunctival hem-
orrhage and chemosis. Discomfort during administration
of the anesthesia can be minimized by prior topical anes-
thetic application or the addition of intravenous sedation.
Postoperative cosmesis and return of visual acuity is inferi-
or as compared to topical anesthesia.
Figure 6-5. Sub-Tenon's block. A blunt-tip cannula is introduced
in the sub-Tenon's space. The cannula is directed posteriorly and
the anesthetic agent is injected (reprinted from Lindquist TD,
Lindstrom RL. Ophthalmic Surgery: Looseleaf and Update
Series: Anesthesia in Ocular Surgery. Orlando, Fla: Elsevier
Science; 1990:IA9, with permission from Elsevier Science).
Complications
Complications of parabulbar anesthesia are rare but
could include injury to the sclera and ciliary nerves and
periorbital hemorrhage. If a needle is used instead of a
blunt cannula, needle-related injuries are possible.
GENERAL ANESTHESIA
History
Since the introduction of local anesthesia, general anes-
thesia for ocular surgery has traditionally been reserved for
young children and during extensive orbital surgery. For
elective ocular surgery, it is mainly reserved for situations
in which patients are not suitable for local anesthesia,
including patients who are anxious, uncooperative, or
uncommunicative; have involuntary movements (ie, head
tremor, nystagmus); or are unable to lie still. In the past,
bleeding disorders were considered a relative indication
for general anesthesia. However, with the development of
topical and parabulbar anesthesia, the risks of retrobulbar
hemorrhage are largely avoided.
Description/Technique
A thorough physical exam should be performed before
deciding if a patient is a good candidate for general anes-
thesia. A review of medications should be employed, as
medications can interact with the anesthetic agents (ie,
monoamine oxidase inhibitors).66 A history of prostate
enlargement should be sought, as this may contribute to
urinary retention in patients undergoing general anesthe-

sia.66 Previous reactions to general anesthesia in the
patient or family members should be addressed.
Additionally, patients that may be difficult to intubate,
such as those with cervical spondylosis, should be identi-
fied and evaluated prior to surgery.
The traditional method of providing general anesthesia
involves endotracheal intubation, paralysis, and ventila-
tion. Induction of anesthesia is done with thiopental,
methohexital, or propofol. Maintenance of anesthesia can
be maintained with inhalational agents such as nitrous
oxide, halothane, enthurane, and isoflurane.
Neuromuscular blockade is achieved by using depolarizing
agents (ie, succinylcholine) or nondepolarizing agents (ie,
pancuronium). Alternatively, a laryngeal mask can be
inserted and anesthesia maintained with a propofol infu-
sion or volatile agent. The use of the laryngeal mask
enables faster turnaround times and reduces the cough
associated with extubation.
Advantages/Disadvantages
The advantages of general anesthesia include patient
comfort, ideal operating conditions, no needle-associated
risks of local anesthetic blocks, no akinesia or amaurosis at
the conclusion of surgery, and better conditions for pro-
longed cases or teaching. As the patient population for
phakic IOLs is skewed toward higher myopes with long
eyes, general anesthesia may be a safer alternative to
regional blocks in some patients.
A disadvantage of general anesthesia is that if paralytics
are used, they may wear off before the surgery is complete.
Alternatively, the patient may remain paralyzed at the
completion of the surgery, delaying spontaneous respira-
tions. Because of the time associated with inducing gener-
al anesthesia and waiting for spontaneous respiration to
ensue, turn around times between cases may be prolonged.
Increased turn around time and more extensive equipment
and monitoring make general anesthesia a more expensive
alternative. This is often not desirable when the surgery is
an out-of-pocket expense. In one study, there was an
increased risk of intraoperative myocardial ischemic events
in elderly patients undergoing cataract surgery with gen-
eral anesthesia as compared to a peribulbar block.67
However, the patients in that study had risk factors for
myocardial ischemia, which are uncommon in the patient
population undergoing phakic IOL implantation.
Complications
One of the most feared complications of general anes-
thesia is malignant hyperthermia. Malignant hyperthermia
is a rare consequence of general anesthesia with an inci-
dence in adults of approximately 1 in 50,000.68 It is an
autosomal dominant defect in muscle metabolism that is
triggered by anesthesia agents and succinylcholine. A his-
Anesthesia for Phakic Intraocular Lenses 53
tory of reactions to anesthesia in family members should
be sought. Physicians should also be familiar with the signs
and symptoms of malignant hyperthermia, which include
tachycardia, tachypnea, hypercarbia, muscle spasms, aci-
dosis, hyperkalemia, hypovolemia, and hyperthermia.
Treatment consists of cooling the patient with ice baths,
iced saline, and cold water lavage. Oxygen, bicarbonate,
and dantrolene sodium should also be on hand. Local anes-
thesia is preferred in patients who may be susceptible to
malignant hyperthermia.
Ocular complications of general anesthesia are rare.
Postoperative extubation difficulties, coughing, or vomit-
ing can lead to valsalva retinopathy, retinal detachment,
bleeding, wound dehiscence, or loss of vitreous.69
Additionally, if the unoperative eye is not taped during
surgery, it may lead to exposure keratopathy or a corneal
abrasion.
CONCLUSIONS
There are multiple techniques to achieve adequate
anesthesia for phakic IOL placement. Although supportive
literature of anesthetic techniques is derived from cataract
surgery patients, it can be extrapolated to phakic IOL
placement. The decision as to which technique to use
should be individualized and based on the patient’s char-
acteristics and desires, the type of surgery performed, sur-
geon preference, and risk factors associated with the vari-
ous techniques.
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Philadelphia, Pa: Lippincott, Williams and Wilkins; 2000:1-
32.
59. Greenbaum S. Parabulbar anesthesia. Am J Ophthalmol.
1992;114:776.
60. Greenbaum S. Anesthesia in cataract surgery. In:
Greenbaum S, ed. Ocular Anesthesia. Philadelphia, Pa: WB
Saunders; 1997:1-55.
61. Anderson CJ. Subconjunctival anesthesia in cataract sur-
gery. J Cataract Refract Surg. 1995;21:103-105.
62. Petersen WC, Yanoff M. Subconjunctival anesthesia: an
alternative to retrobulbar and peribulbar techniques.
Ophthalmic Surg. 1991;22:199-201.
63. Anderson CJ. Combined topical and conjunctival anesthesia
in cataract surgery. Ophthalmic Surg Lasers. 1995;26:205-
208.
64. Anderson CJ. Circumferential perilimbal anesthesia.
J Cataract Refract Surg. 1996;22:1009-1012.
65. Anderson CJ. Circumferential perilimbal anesthesia for
combined cataract and glaucoma surgery. Ophthalmic Surg
Lasers. 1999;30:205-207.
66. Greenhalgh DL. Anesthesia for cataract surgery. In: Yannoff
M, Duker JS, eds. Ophthalmology. London, UK: Mosby;
1999:21.1-21.6.
67. Glantz L, Drenger B, Gozal Y. Perioperative myocardial
ischemia in cataract surgery patients: general versus local
anesthesia. Anesth Analg. 2000;91:1415-1419.
68. Rosenberg H, Fletcher JE. An update on the malignant
hyperthermia syndrome. Ann Acad Med Singapore.
1994;23:84-97.
69. Donlon JV. Anesthesia for ophthalmic surgery. In: Albert
DM, Jakobiec FA, eds. Principles and Practice of
Ophthalmology: Clinical Practice. Philadelphia, Pa: WB
Saunders; 1994:2858-2867.

Astigmatism Management at the
Time of Phakic Intraocular Lenses
Louis D. Nichamin, MD
INTRODUCTION
Astigmatism management represents an important and
challenging facet of any refractive surgical procedure, and
this certainly pertains to the use of phakic intraocular lens-
es (IOLs). Estimates of the incidence of significant, natu-
rally occurring astigmatism vary from 7.5% to 75%.1 It is
thought that 3% to 15% of eyes may have two or more
diopters (D) of astigmatism.2 Although some degree of
pre-existing astigmatism may be reduced when using pha-
kic IOLs, a substantial number of patients will clearly
require treatment for this condition. Patient selection,
quantification of astigmatism, treatment options, and tech-
niques are all important considerations and will be dis-
cussed below.
PATIENT SELECTION
It is generally agreed that uncorrected astigmatism of
greater than 0.5 D will lead to symptoms of ghosting and
shadows. When using myopic phakic IOLs, it has been our
experience that some degree of pre-existing cylinder is
dampened, presumably due to image magnification. This is
consistent with the frequent finding of an increase in best-
corrected visual acuity postoperatively. With this in mind,
one may be slightly less aggressive in his or her approach
to the treatment of astigmatism, but levels of greater than
1.00 D are likely to leave the patient symptomatic and,
therefore, should be addressed.
7
Chapter
Important also is the location of the astigmatism, age of
the patient, and status of the fellow eye. Because most
individuals will drift against-the-rule over their lifetime,
many surgeons advocate a less aggressive approach to the
reduction of with-the-rule cylinder. The widely held tenet
that residual (myopic) with-the-rule astigmatism favors
better distance vision and against-the-rule benefits near
vision pertains more to the pseudophakic state and, as
such, maximizing the position of the conoid of Sturm
becomes less relevant in the context of phakic IOLs. It is
well known, however, that oblique cylinder is poorly tol-
erated, and one must opt to avoid a disparity in the axis of
cylinder between each eye in order to minimize meridion-
al aniseikonia.
The surgeon must also factor into account the astig-
matic effect of the incision needed to implant the phakic
lens. Most foldable lens styles and their small incisions will
have negligible effect, particularly when they are inserted
temporally.3 These small incisions have also been shown
to stabilize rapidly and show little drift.4 This cannot,
however, be said of incisions in the range of 6.0 mm,
which are typically needed to insert rigid lens styles, and
it is generally agreed that superiorly placed incisions will
have greater postoperative drift and wound flattening.5
This phenomenon may in fact be used to reduce pre-exist-
ing astigmatism when the incision is placed upon the steep
meridian as described later in the chapter. If a larger inci-
sion is needed to accommodate a particular implant style,
the astigmatic effect may be minimized through incision
design.6
58 Chapter 7
TREATMENT OPTIONS
The first decision faced by the surgeon is whether to
address pre-existing astigmatism at the time of implanta-
tion or to defer and treat the cylinder separately. One
could argue that for the highest level of accuracy, suffi-
cient wound healing should take place and a stable refrac-
tion ought to be documented prior to astigmatic correc-
tion. This consideration is more important with rigid lens-
es and larger incisions. In addition, residual spherical error
may be corrected along with astigmatism at a second sit-
ting by utilizing a bioptics approach, as described later in
the chapter. Many surgeons, however, feel that once they
have determined the astigmatic effect of the implant inci-
sion and it is factored into their strategy, concomitant
treatment of pre-existing astigmatism is a more efficient
approach. It is more favored because it is likely to save the
patient from having to undergo a second procedure.
The next major decision is whether to treat the astig-
matism utilizing a lenticular approach (ie, to employ a
toric IOL or a keratorefractive technique). From a theoret-
ical standpoint, it is hard to argue against the use of a toric
phakic IOL. However, not unlike toric pseudophakic
implants, limited designs currently exist and similar intra-
operative challenges arise as to proper axis alignment.
Additionally, long-term stability will need to be con-
firmed.7,8 Early studies are nonetheless quite promising,
and the use of such lenses will likely increase in the
future.9
As noted, one can positively affect pre-existing cylinder
by manipulating the implant incision’s location, size, and
design.10 Specifically, one can center the incision upon
the steep meridian and then increase or decrease the
amount of flattening that will occur by increasing or
decreasing the length of the incision. Similarly, one can
increase wound flattening by moving closer to the visual
axis or by creating a more circumparallel incision to the
limbus. This approach, however, presents logistical chal-
lenges by requiring movement about the operating table
and may potentially require awkward hand positions. This
is important when considering phakic intraocular surgery
in which very delicate maneuvers may be required. For
these reasons, as with pseudophakic lens surgery, a more
common incisional strategy is to utilize a consistent and
reproducible implant incision, typically located temporal-
ly and as astigmatically neutral as possible, and then cor-
rect significant pre-existing astigmatism separately.
Currently, this latter element most commonly takes the
form of corneal or limbal relaxing incisions (LRIs).
Limbal Relaxing Incisions
Our experience with the use of LRIs originated from
the work of Dr. Stephen Hollis. Through refinement of his
nomogram, along with the addition of Dr. Spencer
Thornton’s age modifiers, the author now utilizes a system
for astigmatism reduction that is more forgiving and less
demanding than that using smaller optical zones and true
“corneal” astigmatic relaxing incisions. Other surgeons
have experienced similar results with comparable tech-
niques,11,12 and published reports have subsequently doc-
umented the safety and efficacy of LRIs.13,14
An advantage of LRIs includes less tendency to cause
axis shift. This presumably occurs because the need to cen-
ter the incisions precisely upon the steep meridian
decreases. Perhaps more importantly, these more periph-
eral incisions are less likely to induce irregular corneal flat-
tening and, hence, irregular astigmatism. Technically,
they are easier to perform than shorter and more central
corneal astigmatic incisions, and patients generally report
less discomfort.
Yet another advantage gained by moving out to the
limbus relates to the “coupling ratio,” which describes the
amount of flattening that occurs in the incised meridian
relative to the amount of steepening that is induced
90 degrees away. LRIs exhibit a very consistent 1:1 cou-
pling ratio; therefore, little if any change occurs in the
spheroequivalent, thus obviating the need to alter the
power of the phakic IOL. Admittedly, these incisions are
less powerful than corneal incisions, but one can correct
up to 3 D of astigmatism depending upon the age of the
patient. One must keep in mind that the goal is to reduce
the patient’s cylinder without overcorrecting or shifting
the axis.
Measuring Astigmatism
Perhaps the most challenging and often frustrating
aspect of astigmatism surgery deals with the determination
of the quantity and exact location of the preoperative
cylinder that needs to be corrected. Unfortunately, preop-
erative measurements—keratometry, refraction, and
topography—do not always agree. Lenticular astigmatism
may account for some of this disparity; however, the
author’s experience supports the notion that traditional
measurements of astigmatism (eg, those obtained with
standard keratometry [only 2 points measured in each
meridian]) do not always adequately describe the astig-
matic state of a patient.
When confounding measurements are obtained, one
can compromise and average the disparate readings. This
is frequently done when using LRIs at the time of cataract
and implant surgery.15 Unlike pseudophakic surgery,
lenticular astigmatism is not eliminated when using phakic
IOLs and, as such, more emphasis is placed upon the
patient’s manifest refraction rather than keratometry.
Corneal topography is often helpful when the refraction
and keratometry differ and may act as a “tie-breaker.”
Topography, of course, is also helpful in detecting subtle
corneal pathology, such as keratoconus fruste, which
would likely negate the use of LRIs.
 Astigmatism Management at the Time of Phakic Intraocular Lenses 59

Table 7-1

THE “NAPA” NOMOGRAM: NICHAMIN AGE AND PACH-ADJUSTED

INTRALIMBAL ARCUATE ASTIGMATIC NOMOGRAM*
20 to 30 30 to 40 40 to 50 50 to 60
Preoperative Cylinder years old years old years old years old
0.75 40 35 35 30
1.00 45 40 40 35
1.25 55 50 45 40
1.50 60 55 50 45
1.75 65 60 55 50
2.00 70 65 60 55
2.25 75 70 65 60
2.50 80 75 70 65
2.75 85 80 75 70
3.00 90 90 85 80

*When placing intralimbal relaxing incisions following or concomitant with radial relaxing incisions, total
arc length is decreased by 50%.

ter may significantly influence the relative arc length of the

Figure 7-1. Nomogram design. Note relative dis-
parity in incision length between a large and small
corneal diameter if measured in millimeters.
Degrees of arc lend consistency irrespective of
corneal size.
Once the amount and location of the astigmatism has
been determined, a number of different nomograms may be
consulted.16 As mentioned, the author’s preferred nomo-
gram is based upon that of Hollis and incorporates the sur-
gical principles described by Thornton (Table 7-1).17 This
nomogram utilizes paired incisions rather than longer sin-
gle incisions to optimize symmetric corneal flattening and
is expressed in degrees of arc rather than millimeters. This
is done to avoid over and under corrections that may occur
in unusually small or large corneas because corneal diame-
incision and its resultant effect (Figure 7-1).
Surgical Technique
Increasing evidence indicates that significant cyclotor-
sion may occur when assuming a supine position.18 For
this reason, most surgeons advocate placing an orientation
mark at the 12:00 or 6:00 limbus while the patient is in an
upright position. According to Euler’s theorem, an axis
deviation of 5, 10, or 15 degrees will result in 17%, 33%,
and 50% reduction, respectively, in surgical effect.19 This
is particularly important when employing injection anes-
thesia wherein unpredictable eye rotation may occur. An
additional measure to help accurately center the relaxing
incisions is to identify the steep meridian (plus cylinder
axis) intraoperatively by using some form of keratoscopy.
The steep meridian over which the incisions are centered
corresponds to the shorter axis of the reflected corneal
mire. A simple hand-held device such as the Maloney ker-
atoscope (produced by a number of manufacturers) works
nicely, or a more elaborate microscope-mounted instru-
ment may be used, such as the Mastel Ring of Light
(Mastel Precision, Rapid City, SC). The steep meridian
may also be identified by aligning a Mendez ring (Rhein
Medical, Tampa, Fla) or similar degree gauge with the pre-
viously placed 12:00 or 6:00 limbal orientation mark, and
then locating the cylinder axis on the 360-degree marker.
60 Chapter 7
Figure 7-2. Peripheral AK dia-
mond blade by Mastel Precision
incorporates a special preset
600 ␮m diamond and a single
contoured footplate.
Figure 7-4. Steep meridian is confirmed intraoperatively by ker-
atoscopy. In this left eye viewed from the temporal side, the
“short axis” of the corneal mire is seen to be at the 75-degree
meridian.
The LRIs are placed at the most peripheral extent of
clear corneal tissue, just inside of the true surgical limbus.
This is done regardless of the presence of blood vessels or
pannus. If bleeding occurs, it may be ignored and will stop
spontaneously. Care must be taken not to place the inci-
sions further out at the true surgical limbus because a sig-
nificant reduction of effect is likely to occur; therefore,
these incisions are really intralimbal in nature.
In the setting of concomitant cataract surgery, an
empiric blade depth setting of 600 ␮m is commonly used.
For the younger patient population that would likely
undergo phakic IOL implantation, adjusted blade depth
settings based upon pachymetric measurements may be
justified. If pachymetry is performed, the micrometer is set
at 100% of the thinnest reading obtained over the entire
arc length of the intended incision. Diamond blade style
and configuration may influence results and require an
adjustment in blade depth settings and/or the nomogram.
The author’s personal preference is to utilize a diamond
blade specifically designed for this technique (Mastel
Figure 7-3. The Nichamin Modified Fine-Thornton fixation
ring. A two-cut radial marker may be used to mark the
extent of arc to be incised upon the cornea.
Precision, Rapid City, SC) (Figure 7-2). Similar designs are
available from Rhein Medical (Tampa, Fla), ASICO
(Westmont, Ill), and other manufacturers.
The extent of arc to be incised may be demarcated in
several different ways. The author’s preferred method
makes use of a modified Fine-Thornton fixation ring
(Mastel Precision, Rapid City, SC) that serves to both fix-
ate the globe and delineate the extent of arc to be incised.
One simply extrapolates visually from the limbus where
the incision is being made to marks on the surface of the
ring (Mastel Precision [Rapid City, SC], Rhein Medical
[Tampa, Fla], and Storz [St. Louis, Mo]). Each incremen-
tal mark is 10 degrees apart, and bold hash marks (180
degrees) opposite to each other are used to align the steep
axis. This approach avoids inking and marking of the
cornea. If one desires, a two-cut radial keratotomy (RK)
marker may be used to mark the exact extent of arc to be
incised in conjunction with the fixation ring/gauge (Figure
7-3). Alternatively, various press-on markers are available,
such as those made by Rhein Medical (Nichamin-
Kershner LRI markers or the Dell marker). Attention to
detail is important in achieving a good result surgically
(Figures 7-4 to 7-21).
Complications
LRIs are indeed proving to be a safer and more forgiving
approach for reducing astigmatism but, as with any surgical
procedure, the potential for complications will always exist,
and several are listed in Table 7-2. Of those listed, placing
the incisions upon the wrong axis is likely to be the most
common error experienced. When this complication is
encountered, it typically takes the form of a 90-degree mis-
take, with the incisions being placed upon the opposite, flat
meridian. This, of course, leads to an increase and probable
doubling of the patient’s cylinder. Compulsive attention is
needed in this regard, and safety checks, such as clear writ-
 Astigmatism Management at the Time of Phakic Intraocular Lenses
Figure 7-5. The broad hash marks of the fixation ring/gauge are
centered over the 75-degree meridian, using the 6:00 limbal
mark for orientation. Alternatively, a Mendez gauge may be
used.
Figure 7-7. The incision shown in Figure 7-6 is seen as it is com-
pleted 22.5 degrees to the opposite side.
Figure 7-9. The incision is begun 20 degrees to one side of
the centering mark.
61
Figure 7-6. The single footplate diamond blade is inserted per-
pendicular to the corneal surface and at the peripheral most
extent of clear corneal tissue. In this case, the nomogram calls
for arcuate incisions of 45 degrees. Therefore, the incision is
begun approximately 22.5 degrees to one side of the broad hash
mark.
Figure 7-8. In this left eye, the steep meridian is at the 120-
degree axis and has been delineated by opposing limbal
marks. The upper left hand ink mark represents the 6:00
position for orientation.
Figure 7-10. The incision is completed.
62 Chapter 7

Figure 7-11. Total arc length equals 40 degrees. Figure 7-12. The starting point of the opposing inci-
sion is determined.

Figure 7-13. The opposing incision is begun.

Figure 7-14. The incision is completed.

Figure 7-15. The temporal single-plane clear corneal

incision is placed independent of the LRIs. Figure 7-16. In this case, the steep meridian is at 90
degrees. The fixation ring/gauge is therefore centered
with the 6:00 limbal mark.
 Astigmatism Management at the Time of Phakic Intraocular Lenses
Figure 7-17. The nomogram calls for arcuate incisions
of between 45 and 50 degrees. Each incremental
mark on the ring equals 10 degrees. The surgeon,
therefore, counts over 25 degrees to one side of the
centering hash mark.
Figure 7-19. The incision is completed an equal dis-
tance past the centering mark, visually extrapolating
to the 10-degree marks on the surface of the ring.
Figure 7-21. The incision is completed. Note a small
amount of blood within the incision.
ten plans, should be available within the surgical suite for ref-
erence. Incisions are always placed upon the plus (+) cylin-
der axis and opposite to the minus (-) cylinder axis.
Although rare, perforation may occur when utilizing an
empiric blade depth setting of 600 ␮m or pachymetry
63
Figure 7-18. The blade is inserted.
Figure 7-20. The blade is held above the starting
point of the opposite incision.
derived settings. If encountered, these circumferential per-
forations, unlike radial microperforations, will not self-seal
and do require placement of sutures.
Bioptics
Another option to manage pre-existing astigmatism is
to employ a technique originally described by Zaldivar:
“bioptics.” In this approach, excimer laser surgery is used
to refine the refractive outcome following posterior cham-
ber phakic IOL surgery for the high myope.20 Others have
utilized a similar technique when utilizing other phakic
IOL designs.21 Its initial conception came about due to the
inherent difficulties and often unpredictable refractive out-
comes encountered in this patient population; the preop-
erative refraction in the very high myope is hampered due
in part to image minification and vertex distance consider-
ations. If the selected phakic IOL power was off, LASIK
would be performed to refine residual refractive error.
This same approach may be taken to treat residual
astigmatism. Although LRIs are effective, it is difficult to
compete with the exquisite accuracy achievable through
excimer technology. One must, however, weigh these
considerations against the additional risk, costs, and logis-
tical concerns of this second operation. LASEK and other
64 Chapter 7
Table 7-2
POTENTIAL PROBLEMS WITH LIMBAL RELAXING INCISIONS
• Infection • Induced irregular astigmatism
• Weakening of the globe • Misalignment/axis shift
• Perforation • Wound gape and discomfort
• Decreased corneal sensation • Operating upon the wrong (opposite) axis
surface ablation techniques are other options, particularly
if wave-front technology is to be utilized.22,23 Similarly,
other nonlaser technologies may be used in this bioptics
approach. Although laser thermal keratoplasty seems to be
falling out of favor at this time, conductive keratoplasty
may hold promise as being a way to simply and safely treat
residual hyperopia as well as mixed and hyperopic astig-
matism.
CONCLUSION
Reduction or elimination of significant pre-existing
astigmatism is an important element of phakic IOL sur-
gery. Several different options exist, including the use of a
toric implant. The availability and use of such devices is
likely to increase markedly in the future. Currently, other
approaches include tailoring of the implant incision to
positively affect the pre-existing cylinder or using adjunc-
tive relaxing incisions. This latter option has been made
more facile and safer by moving their location to an intra-
limbal position. Additional keratorefractive modalities,
such as the excimer laser, may be called upon to refine
astigmatic error, often in a staged or bioptics approach.
REFERENCES
1. Abrams D. Ophthalmic optics and refraction. In: Duke-
Elder SS, ed. System of Ophthalmology. St. Louis, Mo:
Mosby; 1970:671-674.
2. Buzard K, Shearing S, Relyea R. Incidence of astigmatism in
a cataract practice. J Refract Surg. 1988;4:173.
3. Lyle WA, Jin G. Prospective evaluation of early visual and
refractive effects with small clear corneal incision for
cataract surgery. J Cataract Refract Surg. 1996;22(10):
1456-1460.
4. Masket S, Tennen DG. Astigmatic stabilization of 3.0 mm
temporal clear corneal cataract incisions. J Cataract Refract
Surg. 1996;22(10):1451-1455.
5. Drews RC. Five year study of astigmatic stability after
cataract surgery with intraocular lens implantation: compar-
ison of wound sizes. J Cataract Refract Surg. 2000;26(2):
250-253.
6. Anonymous. Small incision surgery: wound construction
and closure. J Cataract Refract Surg. 1991;17(Suppl):653-
748.
7. Ruhswurm I, Scholz U, Zehetmayer M, et al. Astigmatism
correction with a foldable toric intraocular lens in cataract
patients. J Cataract Refract Surg. 2000;26(7):1022-1027.
8. Sun XY, Vicary D, Montgomery P, et al. Toric intraocular
lenses for correcting astigmatism in 130 eyes.
Ophthalmology. 2000;107(9):1776-1781.
9. Dick HB, Alio JA, Bianchetti M, et al. Toric phakic intraoc-
ular lens European multicenter study. Ophthalmology.
2003;110(1):150-162.
10. Kohnen T, Koch DD. Methods to control astigmatism in
cataract surgery. Curr Opin Ophthalmol. 1996;7(1):75-80.
11. Kershner RM. Refractive cataract surgery. Curr Opin
Ophthalmol. 1998;9:46-54.
12. Gills JP. Treating astigmatism at the time of cataract sur-
gery. Curr Opin Ophthalmol. 2002;13(1):2-6.
13. Budak K, Friedman NJ, Koch DD. Limbal relaxing incisions
with cataract surgery. J Cataract Refract Surg. 1998;24(4):
503-508.
14. Nichamin LD. Changing approach to astigmatism manage-
ment during phacoemulsification: peripheral arcuate astig-
matic relaxing incisions. Paper presented at: Annual meeting
of the American Society of Cataract and Refractive Surgery;
May 20, 2000; Boston, Mass.
15. Nichamin LD. Reducing astigmatism. In: Wallace RB, ed.
Refractive Cataract Surgery and Multifocal IOLs. Thoro-
fare, NJ: SLACK Incorporated; 2000:167-172.
16. Budak K, Friedman NJ, Koch DD. Limbal relaxing incisions
with cataract surgery. J Cataract Refract Surg. 1998;24(4):
503-508.
17. Thornton SP. Radial and Astigmatic Keratotomy: The
American System of Precise, Predictable Refractive Surgery.
Thorofare, NJ: SLACK Incorporated; 1994.
18. Swami AU, Steinert RF, Osborne WE, et al. Rotational mal-
position during laser in situ keratomileusis. Am J
Ophthalmol. 2002;133(4):561-562.
19. Abrams D. Ophthalmic optics and refraction. In: Duke-
Elder SS, ed. System of Ophthalmology. St. Louis, Mo:
Mosby; 1970:671-674.
 Astigmatism Management at the Time of Phakic Intraocular Lenses 65

20. Zaldivar R, Davidorf JM, Oscherow S, et al. Combined pos-
terior chamber phakic intraocular lens and laser in situ ker-
atomileusis: bioptics for extreme myopia. J Refract Surg.
1999;15(3):299-308.
21. Guell JL, Vazquez M, Gris O, et al. Combined surgery to
correct high myopia: iris-claw phakic intraocular lens and
laser in situ keratomileusis. J Refract Surg. 1999;15(5):529-
537.
22. Durrie DS. Are stromal flaps necessary: patient acceptance
and results of LASEK (talk). Presented at the American
Academy of Ophthalmology Annual Meeting; October 18,
2002; Orlando, Fla.
23. Durrie DS. LASIK vs PRK/LASIK vs LASEK (talk).
Presented at the American Academy of Ophthalmology
Annual Meeting; October 18, 2002; Orlando, Fla.

Comparison of Phakic Intraocular
Lenses With Corneal Refractive Surgery
Louis E. Probst, MD
INTRODUCTION
Both phakic intraocular lenses (IOLs) and corneal
refractive surgery have received a large degree of interest
for the correction of refractive errors. The most common
corneal refractive surgery performed in most countries
throughout the world is laser in-situ keratomileusis
(LASIK).1 The predominant phakic IOLs that are used
worldwide include the Artisan (Ophtec USA, Inc/Allergan,
Boca Raton, Fla) and the Implantable Contact Lens (ICL)
(STAAR Surgical, Monrovia, Calif), although several other
types are available (Table 8-1). While both procedures can
achieve excellent outcomes, they have very different ranges
of correction, indications, contraindications, surgical tech-
niques, results, and complications. It is important that the
refractive surgeon understand all of the options available
for each patient, as some patients will be excellent candi-
dates for one procedure and poor candidates for another.
The diagram for the options of refractive surgery (Figure 8-
1) describes all of the various refractive procedures that are
currently available in 2003.
RANGE OF CORRECTION
The standard range of correction for LASIK extends
from 1.00 to 10.00 diopters (D) of myopia with an extend-
ed range up to 12 D of myopia. The range for hyperopic
LASIK extends from 1.00 to 3.00 D with an extended
range up to 4.00 D of hyperopia. Standard astigmatic
LASIK can correct up to 3.00 D. Cross cylinder LASIK can
extend astigmatism correction up to 8.00 D.2
Chapter
8
The range of correction of LASIK is limited by the
corneal thickness and the keratometry of the cornea. At
least 250 ␮m of posterior stroma should be preserved after
LASIK to prevent long-term ectasia of the cornea. If the
flap is assumed to be 160 ␮m, the total corneal thickness
after LASIK should be at least 410 ␮m. Because the aver-
age corneal thickness is approximately 540 ␮m and the
standard myopic correction removes about 15 ␮m per
diopter with most modern excimer lasers, the maximum
average correction is limited to less than 9.00 D.3 While
this range can be extended with thicker corneas or smaller
optical zones, the optical zone used for LASIK should
always account for the preoperative pupil size.4
The range of LASIK correction is also limited by the
keratometry of the cornea.5 Corneal flattening to less than
35.00 D is associated with a higher incidence of a loss of
best-corrected visual acuity (BCVA) and regression.
Myopic LASIK flattens the cornea by approximately 70%
of the spherical equivalent.6 Therefore, the maximum cor-
rection with a preoperative keratometry value of 40.00 D
would be approximately 7.00 D. Corneal steepening
greater than 50.00 D has been associated with a central
superficial keratitis caused by ineffective tear film distribu-
tion over the steep cornea (Figure 8-2). Because the hyper-
opic steepening effect is 100%, the maximum correction
of a cornea with preoperative keratometry of 47.00 D
would be 3.00 D.
Phakic IOLs are not associated with the limitations of
LASIK, as they do not alter the thickness or curvature of
the cornea. While phakic IOLs could be used to correct
the full range of refractive errors, they are generally used
for the correction of higher levels of myopia and hyper-
68 Chapter 8

Table 8-1

PHAKIC IOLS AVAILABLE FOR REFRACTIVE SURGERY

Anterior Chamber
Baikoff NuVita MA20 lens Bausch & Lomb Surgical, Rochester, NY
Phakic 6 Ophthalmic Innovation International, Ontario, Canada
Vivarte IOLTECH Laboratories, La Rochelle, France/CIBA Vision, Duluth, Ga

Iris-claw IOL
Artisan lens Ophtec BV, Groningen, Netherlands /Advanced Medical Optics, Irvine,
Calif

Posterior Chamber
Implantable Contact Lens (ICL) STAAR Surgical, Groningen, Netherlands
Phakic Refractive Lens (PRL) Medennium Inc, Irvine, Calif/CIBA Vision, Duluth, Ga

Figure 8-1. The diagram of

refractive surgery illustrates the
options for refractive surgery in
2003. LASIK is used for the
lower ranges of myopia and
hyperopia, while phakic IOLs
are used for the more extreme
refractive errors.

opia. This is because LASIK offers a high degree of accu-
racy for the correction of the smaller refractive errors with
a higher level of convenience for the patients. Therefore,
phakic IOLs are generally used for those patients that are
not LASIK candidates.
Phakic IOLs have a standard range between 10.00 to
22.00 D of myopia with an extended lower range of myopia
down to 5.00 D. For hyperopia, phakic IOLs are used for
+4.00 to +10.00 D of hyperopia but can be extended down
into the +3.00 D range. Toric versions of the anterior cham-
ber phakic IOL (ie, Vivarte), the ICL, and the Artisan pha-
kic IOL have recently become available internationally,
allowing the correction of up to 3.00 D of astigmatism asso-
ciated with the spherical refractive errors. Most patients
with residual astigmatism after nontoric phakic IOL implan-
tation have LASIK as an enhancement procedure in a two-
step procedure that Zaldivar named bioptics (Figure 8-3).7
 Comparison of Phakic Intraocular Lenses With Corneal Refractive Surgery
Figure 8-2. Central superficial keratitis associated with
a loss of two lines of BCVA 2 months after +4.00
hyperopic LASIK correction.
Figure 8-4. LASIK is the
preferred option for the
correction of residual
refractive errors after
radial keratotomy.
INDICATIONS
Both phakic IOLs and LASIK are elective refractive
procedures; therefore, they are only indicated in patients
that have been fully informed of their options for the cor-
rection of their refractive error. A thorough preoperative
consent form should be completed by all patients prior to
the procedure. Patients should understand the advantages
as well as the limitations of refractive surgery. Realistic
expectations are an important prerequisite for refractive
surgery. The minimum age for refractive procedures is
18 years of age. However, refractive surgery is often done
after 21 years of age to ensure refractive stability over the
preceding 12 months. Both LASIK and phakic IOLs are
generally performed on normal, healthy eyes.
LASIK is indicated for low to moderate levels of
myopia, hyperopia, and astigmatism correction because of
the relatively high accuracy and the low risk of surgical
complications. Standard excimer laser ablations for LASIK
can only treat regular astigmatism; however, customized
wavefront LASIK corrections may allow irregular patterns
to be treated in the near future. Successful LASIK also
requires a stable corneal epithelium and normal corneal
thickness.
LASIK is the preferred procedure for the correction of
residual refractive errors after radial keratotomy (RK)
(Figure 8-4), cataract surgery,8 penetrating keratoplasty,9
69
Figure 8-3. Bioptics is the combination of an intraocular lens
procedure and a corneal refractive procedure, such as LASIK.
refractive lensectomy,10 and phakic IOL implantation,11
as these corrections are generally small. Photorefractive
keratectomy (PRK) after previous corneal surgery has been
associated with a high incidence of corneal haze.12,13
Alternatively, phakic IOLs are best suited for patients
with high levels of myopia or hyperopia, as they are not
restricted by the limitations of corneal correction. While
they certainly can be used to correct lower levels of myopia,
they do not have the precision of the LASIK correction.
They are, therefore, likely to require a LASIK enhancement
procedure afterward in order to refine the residual prescrip-
tion to achieve the best uncorrected visual acuity (UCVA).
They are also associated with a slightly higher surgical risk
because they are intraocular procedures.
Phakic IOLs may be the preferred procedure for the cor-
rection of even smaller refractive errors if the risks for LASIK
are found to be unusually high, such as in the case of preop-
erative forme fruste keratoconus or severe dry eyes. Patients
with unusually thin corneas without any other pathology
may benefit from phakic IOL correction of low refractive
errors. Phakic IOLs can be removed and are, therefore, a
potentially reversible procedure as compared to LASIK,
which ablates corneal tissue that cannot be replaced.
However, since the removal of phakic IOLs is considerably
more difficult than their insertion, it should never be pre-
sented to patients as a readily reversible procedure.
CONTRAINDICATIONS
There are a number of contraindications for LASIK and
phakic IOL surgery. Unrealistic expectations for the out-
come of the procedure are extremely important to ascer-
tain. Patients that expect a guarantee of 20/20 “perfect
vision” postoperatively will generally be disappointed by
the outcome. An unstable refraction, defined as a change
in the sphere or astigmatism by more than 0.5 D over
70 Chapter 8
Figure 8-5. Preoperative keratoconus is a contraindica-
tion for LASIK.
6 months, is a contraindication for any refractive proce-
dure. A preoperative scotopic pupil size greater than 7.0
mm can increase the risk of postoperative night halos after
both phakic IOLs and LASIK and may require operative
adjustments to avoid this complication. Any active corneal
or ocular disease should be treated and stabilized prior to
refractive surgery. If a preoperative opacity is noted in the
crystalline lens, refractive lensectomy/cataract surgery
may be the preferred procedure. Patients that have a
BCVA of 20/40 or less in one eye should be considered
carefully. A reduction in BCVA to less than 20/40 in their
previously “good” eyes could result in the loss of an unre-
stricted driver’s license.
LASIK is contraindicated for patients with corneal
pathology such as forme fruste keratoconus (Figure 8-5), as
it can exacerbate corneal ectasia. If the amount of corneal
thickness is inadequate and the complete LASIK correc-
tion can’t be performed, phakic IOLs are often a better
option. LASIK requires a healthy corneal epithelium to
avoid postoperative epithelial defects with prolonged visu-
al recovery, postoperative pain, interface keratitis, and
epithelial ingrowth.
Phakic IOLs are contraindicated in patients with a shal-
low anterior chamber (depth less than 2.8 mm) as the
insertion and manipulation of the phakic IOL becomes
extremely difficult. Phakic IOL implantation has been
associated with an endothelial cell loss of 5% to 10%14
(Figure 8-6); therefore, any signs of corneal endothelial
weakness, such as guttata or a reduction in the endothelial
cell count less than 2000 cells/mm, should be approached
with caution. A past ocular history of anterior uveitis is a
relative contraindication for phakic IOLs, as any anterior
segment manipulation could cause reactivation of the
inflammation. Presbyopic patients may be better candi-
dates for refractive lensectomy, as this can restore reading
ability if a multifocal lens is used, provide early correction
of a cataract, and achieve excellent visual outcomes.
Figure 8-6. Iris-claw phakic IOLs have been associated with
a progressive loss of endothelial cells (adapted from
Menezo JL, Cisneros AL, Rodriguez-Salvador V. Endothelial
study of iris-claw phakic lens: four year follow-up. J
Cataract Refract Surg. 1998;24(8):1039-1049).
PREOPERATIVE ASSESSMENT
Both phakic IOLs and LASIK involve a detailed preop-
erative assessment. The past ocular history should ideally
be unremarkable. The ocular exam should indicate healthy
eyes without evidence of cataracts. Cycloplegic and sever-
al noncycloplegic refractions are performed to evaluate
the stability of the refractive error and the contribution of
accommodation. Only patients who have stable prescrip-
tions are candidates for a refractive procedure as per-
formed by either method. For both phakic IOLs and
LASIK, topography is required to identify irregular astig-
matism and forme fruste keratoconus. For LASIK, these
conditions are a contraindication for surgery. These con-
ditions do not preclude phakic IOL surgery but do pre-
clude LASIK as an enhancement procedure following pha-
kic IOL insertion. Pupil testing is performed in dim light
with an infrared pupillometer. Pupils 8 mm or greater in
diameter could be associated with postoperative glare with
either procedure.
LASIK outcomes can be affected by certain pre-existing
ocular conditions that should be sought preoperatively.
Anterior basement membrane dystrophy should be identi-
fied. The presence of dry eyes should be determined by
preoperative questioning and Schirmer testing. Patients
with dry eyes preoperatively can be expected to have
exacerbation of their symptoms after LASIK and may ben-
efit from the preoperative placement of punctal plugs.
Corneal thickness measurements should be obtained by
Orbscan or ultrasonic pachymetry to determine the limi-
tations of the excimer ablation. The Orbscan is also help-
ful in identifying preoperative posterior corneal ectasia,
which has been suspected as a precursor of keratoconus
(Figure 8-7).15
 Comparison of Phakic Intraocular Lenses With Corneal Refractive Surgery
Figure 8-7. Preoperative posterior corneal ectasia, as demon-
strated by greater than 50 ␮m of elevation on the posterior float
map, is a contraindication for LASIK.
With phakic IOLs, the healing of the cornea after the
procedure is limited, therefore the risks are different.
However, most of the same tests listed above for LASIK
are performed in phakic IOL candidates, as it is usually
unclear during the initial preoperative assessment which
procedure will be recommended. Patients with corneal
guttata or suspicious endothelial pathology may not be
good candidates for phakic IOLs due to potential endothe-
lial cell loss. Patients with less than a 2.8-mm anterior
chamber depth do not have adequate room to allow the
phakic IOL to be inserted atraumatically. Finally, phakic
IOLs sit close to the crystalline lens and, therefore, the
lens should carefully be evaluated for a cataract. If there is
a cataract present preoperatively, a refractive lensectomy
is preferable because a phakic IOL may induce further
cataract changes. Phakic IOL patients are often high
myopes and, therefore, need to have a careful peripheral
retinal evaluation to ensure that no holes or other retinal
pathology are present that could result in postoperative
retinal detachment.16
PREOPERATIVE CONSENT
The preoperative consent form is essential in any
refractive procedure. This should ideally be given to the
patient prior to the procedure so that he or she has time to
review it. The consent form for refractive procedures
should include the risks of the procedure and the options
for surgery. Patients should understand that they might
not achieve a perfect outcome.
The key differences between the consent forms for pha-
kic IOLs and LASIK relate to the nature of the procedures.
LASIK is generally performed as a simultaneous bilateral
procedure and, hence, the consent should address the
71
Figure 8-8. Retroillu-
mination demonstra-
tes two superior irido-
tomies performed pri-
or to the ICL implanta-
tion.
potential risk of bilateral surgery versus unilateral surgery.
Most complications of LASIK result from the creation of
the corneal flap or the excimer laser ablation of the cornea.
Phakic IOLs are implanted as a unilateral procedure due
to the rare risk of endophthalmitis and the precedent set
by cataract surgery. Consent forms need to be signed
before each procedure. The patient should be made aware
of the risk and symptoms of endophthalmitis so that they
can seek prompt medical attention, if necessary.
Furthermore, phakic IOL patients should understand that
they will often have residual sphere and cylinder after the
phakic IOL procedure and, therefore, may require a
LASIK enhancement in order to achieve the best outcome.
In the United States, the consent form should indicate that
phakic IOLs are considered investigational, as none of the
phakic IOLs have currently been approved by the FDA.
The ICL requires two peripheral iridotomies to be per-
formed prior to the ICL implantation, so an additional
consent is required to describe the risks of this procedure
(Figure 8-8).
PREOPERATIVE PREPARATION
The preparation of patients for LASIK differs from the
preparation of patients for phakic IOLs. LASIK patients
need to have careful protection of their corneal epithelium
to ensure that they do not develop epithelial defects.
LASIK patients should receive a minimal number of pre-
operative drops in order to reduce the risk of toxic ker-
atopathy and epithelial defects. If patients do require dila-
tion for LASIK on the LADARVision laser (Alcon Surgical,
Fort Worth, Tex), it should be done with sponges that are
soaked in the mydriatic drops and then placed under the
lower lid to avoid corneal toxicity.
With phakic IOLs, dilation is required if a posterior
chamber IOL, such as the ICL, is being used. For the iris-
claw or the anterior chamber phakic IOL, pupillary con-
striction may be used. In either case, corneal toxicity is not
a major concern. If topical anesthesia is used, it should be
generously applied preoperatively in order to ensure there
is good penetration of the cornea so that the corneal inci-
sion and the iris manipulation are pain free.
72 Chapter 8
Figure 8-9. Insertion of the ICL is done through a
self-sealing 3-mm clear corneal incision.
SURGICAL TECHNIQUES
The surgical technique for LASIK involves topical anes-
thesia, the keratectomy, and the excimer laser ablation. It
can be performed on both eyes in approximately 10 min-
utes. LASIK can be performed as a simultaneous bilateral
procedure, as it is extraocular with a low risk of endoph-
thalmitis. All other LASIK complications are not consid-
ered interdependent events between eyes except corneal
infection, which has been reported bilaterally.17 LASIK is
not generally performed as a true sterile procedure. The
microkeratome and instruments are autoclaved for each
procedure and sterile disposable instruments are used.
However, strict sterile technique with a sterile operating
room is rarely used.
Phakic IOL implantation involves the creation of a small
peripheral corneal incision under anesthesia, implantation of
the phakic IOL with viscoelastic control, positioning the
phakic IOL, removal of the viscoelastic, and possible sutur-
ing of the incision (Figure 8-9). The procedure is more tech-
nically challenging when compared to LASIK because
bimanual manipulation is required in the anterior chamber.
Phakic IOLs are performed unilaterally with a sterile tech-
nique due to the increased risk of endophthalmitis.
POSTOPERATIVE COURSE
LASIK patients often have slightly blurred vision imme-
diately postoperatively but can see well 4 to 5 hours after
the procedure. A mild dry eye sensation is experienced for a
few hours after LASIK, followed by a rapid resolution. The
following day, LASIK patients usually have excellent vision.
However, over the next several months, there may be some
regression of effect and LASIK patients may require an
enhancement procedure. Visual quality usually improves
over the first several weeks. LASIK patients experience a
neurotrophic cornea after LASIK due to the severed corneal
nerves from the flap creation.18 This creates a temporary
dry eye that generally resolves within a few weeks but can
last several months. LASIK patients are given a topical
steroid and antibiotic to use postoperatively for several
days. They are also given ocular lubricants to use for the first
postoperative month as the neurotrophic cornea recovers.
Phakic IOL patients have rapid improvement of their
vision after IOL implantation. A mild foreign body sensation
may be experienced after the anesthetic wears off and the
corneal incision heals. There is no regression of effect as
there is no corneal healing required. Phakic IOL patients
may still require an enhancement procedure because of resid-
ual spherical or cylindrical error from the original phakic
IOL implantation. There are few associated neurotrophic
changes after phakic IOL implantation. It is important to
check the intraocular pressure after phakic IOL implantation,
as retained viscoelastic can cause an increase in intraocular
pressure immediately after the procedure. The pressure after
phakic IOL implantation should be checked at 1 hour, 4
hours, and 1 day postoperatively. Phakic IOL patients use
topical steroid and antibiotic drops on a tapering schedule
for 4 weeks. Topical lubrication is generally not mandatory.
ENHANCEMENT PROCEDURES
Enhancement procedures are often required for both
LASIK and phakic IOL procedures. For LASIK, there is
variable healing of the cornea, which can require an
enhancement to be performed. Enhancements occur at a
rate of approximately 1% per D of correction, with the
rate varying between 5% to 20% between surgeons and
lasers. The timing of the LASIK enhancement depends on
the amount of the original LASIK correction. Generally,
enhancements should be delayed 1 month for each spher-
ical equivalent of correction, although most enhancements
are practically performed between 3 and 6 months.
Enhancements are also required for phakic IOLs.
Phakic IOLs are excellent at correcting spherical refractive
error; however, they are generally only accurate within
1 D. This means that patients will often have some resid-
ual spherical correction. Patients may also have residual
astigmatism that was not corrected by the phakic IOL
unless a toric phakic IOL was used. In more than 250 ICLs
procedures that the author has performed, approximately
50% of them had returned for LASIK in order to achieve
the best uncorrected vision (Figure 8-10). All of the LASIK
enhancements have been performed without complica-
tions from the previous corneal incision or from movement
of the ICL. These enhancements have been performed as
soon as 1 month after the ICL implantation.
RESULTS AND QUALITY OF VISION
The quality of the vision after refractive surgery can be
evaluated in several ways. The percentage of eyes achiev-
ing 20/20 or 20/40 vision and those that fall between
 Comparison of Phakic Intraocular Lenses With Corneal Refractive Surgery
Figure 8-10. The two
corneal incisions of a
bioptics procedure. The
most peripheral straight
vertical incision is used
for the ICL insertion.
The rounder central
incision, the LASIK flap.
⫾ 0.50 and ⫾ 1.00 D of emmetropia are the standard
measures of success. The percentage of lost BCVA is also
a measure of the safety of the procedure. The safety index
is the ratio of the postoperative BCVA to the preoperative
BCVA. The stability of the refractive change is a measure
of the long-term outcome of the refractive result.
Recently, wavefront testing has allowed the quality of
vision to be evaluated objectively.
Most of the reports of refractive procedures focus on one
procedure and one technique. Reports of LASIK for low
myopia19 and high myopia,20 NuVita phakic IOL,21 Artisan
phakic IOL,22 and the ICL23 are compared in Table 8-2. It
should be noted that the phakic IOLs were all performed in
high myopes in these studies. Because phakic IOLs do not
involve corneal healing postoperatively, the results for pha-
kic IOLs for the correction of low myopia could be expect-
ed to be similar except that they do not correct corneal
astigmatism. Studies of the results of bioptics with the ICL24
and the Artisan25 demonstrate the results of treating all
residual astigmatism and sphere with LASIK. It should be
noted that the UCVA results are dramatically better for low
myopia treated with LASIK. However, the predictability of
the different refractive procedures is similar, particularly
when LASIK is performed as an enhancement procedure.
Few of the procedures had a loss of two or more lines of
BCVA and all showed a large percentage of gain of BCVA,
particularly when a LASIK enhancement procedure after
phakic IOL implantation was performed.
Recently, studies have compared the results of phakic
IOLs and LASIK for the treatment of high myopia. The
results of the Artisan were compared with the results of
LASIK for treatment of high myopia in 25 patients.26 At
the 1-year follow-up, 24% of LASIK and 20% of Artisan
eyes achieved at least 20/25 UCVA. The predictability
was with 1.00 D in 64% of the LASIK eyes and 60% of the
Artisan eyes. The safety index for LASIK was 0.99 and
1.12 for the Artisan. There was no significant difference
between the groups in the amount of anterior chamber
flare, endothelial cell loss, and contrast sensitivity at
1 year. The subjective visual acuity was better in the
Artisan group. In another comparison study of 90 eyes
with high myopia27 treated with these two modalities at
1 year, the UCVA of 20/20 and 20/40 was 20.9 and 88.4%,
73
and 12.2 and 58.5% in the LASIK and the Artisan group,
respectively. No Artisan eyes and 12.2% of LASIK eyes
lost two or more lines of BCVA. More patients in the
LASIK group complained of glare. The quality of the
vision after Artisan implantation was preferred in 72.2% of
patients.
Vukich has recently compared data of 559 LASIK eyes
with 210 ICL eyes for the treatment of myopia of 8 to 12
D.28 At 1 year, 20/20 UCVA and 20/20 BCVA were
achieved by 36% and 82% of LASIK vs 52% and 90% of
the ICL eyes, respectively. Predictability was within 0.50
D at 1 year in 57% of LASIK eyes and 69% of ICL eyes.
The LASIK eyes showed an average regression from -0.06
D at 1 week to -0.51 D at 1 year, while the ICL group had
no regression (Figure 8-11). At 1 year, the loss and gain of
one line of BCVA was 11% and 29% for the LASIK group
and 6% and 49% for the ICL group (Figure 8-12).
Wavefront testing of 10 eyes in each group at least
6 month postoperatively found coma of 0.46 and 0.22 ␮m
and spherical aberration of 0.39 and 0.13 ␮m for LASIK
and ICL, respectively.
COMPLICATIONS
Phakic IOLs and LASIK share some of the same risks.
Both procedures can result in postoperative glare if the sco-
topic pupil size is larger than the optical zone of the laser
treatment or the phakic IOL optic.29 Infection can rarely
occur with both procedures. BCVA can be lost and enhance-
ment procedures are often required for both procedures.
The complication rate with LASIK is low for major
complications. Perforation of the cornea is the most seri-
ous LASIK complication but it has rarely been reported.
Other serious LASIK complications are flap related. A
recent retrospective study evaluated the intraoperative flap
complications in 84,771 cases of LASIK with the ACS or
the Hansatome.30 The rate of all flap complications was
0.302%, partial flaps 0.099%, buttonholes 0.07% (Figure
8-13), thin or irregular flaps 0.087%, and free flaps
0.012%. The incidence of postoperative flap displacement
should be less than 1/1000, although an incidence of over
1% has been reported.31 A recent review of the world lit-
erature found that 41 LASIK infections have been report-
ed to date.32 In a study of 2873 eyes, 19 eyes (0.66%)
developed post-LASIK kerectasia.33
Minor LASIK complications occur with greater fre-
quency. A recent study evaluating the risk factors for intra-
operative epithelial defects during LASIK found an inci-
dence of 9.7% in 247 eyes.34 Diffuse lamellar keratitis is
estimated to occur in 1:200 to 1:500 cases but may occur
in sequential patients (outbreaks) at a specific location
(Figure 8-14). In a study of 3786 eyes, significant epithe-
lial ingrowth occurred in 0.9% of primary LASIK cases and
1.7% of enhancement cases (Figure 8-15).35 A study of
 74
Chapter 8

Table 8-2

RESULTS OF LASIK AND PHAKIC IOLS

Gain of Loss of
>20/20 >20/40 >2 Lines >2 Lines
Follow-Up Myopia UCVA UCVA of BCVA of BCVA
Author N (eyes) (months) (D) (%) (%) ± 0.5D± 1.0 D (%) (%)
LASIK—low myopia Balazsi et al19 125 6 4.01 81.9 94.6 73 91.2 45.1 0

LASIK—high myopia Zaldivar et al20 84 4.5 8.57 22 77 56 83 14 1.3

NuVita IOL Baïkoff et al21 68 24 12.5 NR 47.8 40 65.5 36.2 11.1

Artisan IOL Landesz et al22 67 35 14.7 12.1 40.9 56.7 67.2 NR 0

ICL Zaldivar et al23 124 11 13.4 2 68 44 69 36 0.8

Bioptics ICL Zaldivar et al24 67 3 23 3 69 67 85 76 0

Bioptic Artisan Guell et al25 26 28 18.42 0 77 80.8 100 72.8 0

 Comparison of Phakic Intraocular Lenses With Corneal Refractive Surgery
Figure 8-11. Stability of the refractive result after LASIK and
the ICL. The regression of the average refractive error after
LASIK contrasts with the stable result of the average ICL
error (courtesy of John Vukich).
Figure 8-13. Central button-hole with a “skip” pattern over
the central cornea.
Figure 8-15. Grade two epithelial ingrowth after
LASIK extending 2 mm from the flap edge.
236 LASIK eyes treated for mild to moderate myopia
found that while mild to moderate glare was reported by
10% of patients at the 6 month follow-up, there was no
75
Figure 8-12. Changes in the BCVA after LASIK and phakic
IOLs. Phakic IOLs demonstrate a greater improvement in
BCVA and less of a loss of BCVA (courtesy of John Vukich).
Figure 8-14. Central in-
tracorneal striae and
haze associated with
grade 4 diffuse lamellar
keratitis.
Figure 8-16. Central corneal island with dramatic central
steepening on topography. This is generally associated with
residual myopia, diplopia, and a loss of BCVA.
significant increase in marked or severe glare or halos.36
The incidence of decentrations of 0.5 mm or more has
been found to occur in 20.8% of eyes after PRK.37 Dry eye
symptoms are increased in all patients after LASIK but
become problematic in only a small number of patients.
LASIK flap striae occur in approximately 1/300 cases.
Central islands after LASIK38 are less common with the
advent of scanning excimer lasers (Figure 8-16).
76 Chapter 8

Table 8-3

COMPLICATIONS OF LASIK AND PHAKIC IOLS

Procedure Main Complications Major Complications

LASIK Regression Keratoectasia

Flap striae Corneal perforation
Epithelial ingrowth Infection
Diffuse lamellar keratitis

ICL Pigment dispersion Endophthalmitis

Chronic glaucoma Pupillary block
Cataracts

Artisan Glare Endophthalmitis

Chronic flare Endothelial cell loss
Decentrations Retinal detachment
Dislocations

NuVita Anterior chamber flare Endophthalmitis

IOL rotation Pupillary ovalization
Glare/halos Endothelial cell loss
Elevated IOP

Figure 8-17. Anterior and chronic flare and ocular hypertension (4.8%).39 The
subcapsular cataract
Artisan iris-claw IOL is associated with endothelial
1 year after ICL im-
plantation demonstrat- decompensation (10.9% at 3 years),40 and rarely inflam-
ed by retroillumination mation,41 dislocation,42 and cataracts.43 The ICL has been
through a dilated pu- associated with anterior subcapsular cataracts (2.9% to
pil. 12.6%) (Figures 8-17 and 8-18),44 endothelial cell loss
(12.3% at 4 years),45 peripheral anterior synechiae (Figure
8-19),46 angle closure glaucoma (Figure 8-20),47 elevated
IOP at 3 months,48 pigment dispersion,49 and retinal
detachment.50

FUTURE DEVELOPMENTS
Customized wavefront LASIK is a rapidly evolving field
that allows the excimer laser ablation pattern to be tailored
to the wavefront error of each eye (Figure 8-21). Custom
LASIK has been found to have even better outcomes of
Complications for phakic IOLs depend on the type of
UCVA, BCVA, and reduction in the wavefront error. This
lens implanted (Table 8-3) and have been reported at a
promises to be an exciting and evolving extension of
greater frequency than the major LASIK complications.
LASIK over the next 10 years.
The NuVita anterior chamber phakic IOLs were found at
While phakic IOLs are growing in popularity, they
a 2-year follow-up of 21 eyes to be associated with pupil
continue to be used mainly for the high myopic and
ovalization (40%), endothelial cell loss (15.2%), moderate
hyperopic corrections in patients who are not LASIK can-
glare (20%), IOL rotation more than 15 degrees (14.2%),
didates or have presbyopia. The recent introduction of
 Comparison of Phakic Intraocular Lenses With Corneal Refractive Surgery
Figure 8-18. Anterior
subcapsular cataract
1 year after ICL implan-
tation on direct illumi-
nation through an undi-
lated pupil.
Figure 8-20. Pupillary block glaucoma 1 year
after ICL insertion. Note the dilated pupil and
transillumination of the iris, indicating areas of
early atrophy.
toric phakic IOLs should expand the range of correction
for phakic IOLs and reduce the enhancement rate. While
two of the phakic IOLs are now foldable, smaller suture-
less incisions will be possible once this is possible with the
other phakic IOLs. Refinement of the phakic IOL proce-
dures and the implantation techniques will further improve
the results. Phakic IOLs may soon be designed to incor-
porate wavefront correction as well. All of these improve-
ments may extend the range of correction of phakic IOLs
to lower levels of myopia and hyperopia in the future.
REFERENCES
1. Duffey RJ, Leaming D. U.S. trends in refractive surgery:
2001 International Society of Refractive Surgery survey.
J Refract Surg. 2002;18(2):185-188.
2. Probst LE. Pure cross cylinder ablation for mixed astigma-
tism. Paper presented at: ASCRS; April 29, 2001; San
Diego, Calif.
3. Probst LE, Machat JJ. The mathematics of LASIK for high
myopia. J Cataract Refract Surg. 1998;24(2):190-195.
4. Fan-Paul NI, Li J, Miller JS, Florakis GJ. Night vision distur-
bances after corneal refractive surgery. Surv Ophthalmol.
2002;47(6):533-546.
77
Figure 8-19. Peripheral touch of
the ICL to the edge of the iris is
demonstrated on anterior seg-
ment ultrasound.
Figure 8-21. Bausch & Lomb’s Zyoptix custom wavefront map
demonstrating the higher order root mean square aberrations
and the point spread function.
5. Probst LE. Complex preoperative LASIK considerations. In:
Probst LE, ed. Complex Cases With LASIK. Thorofare, NJ:
SLACK Incorporated; 2000.
6. Randleman JB, Loupe DN, Song CD, Waring GO 3rd,
Stulting RD. Intraocular lens power calculations after laser
in situ keratomileusis. Cornea. 2002;21(8):751-755.
7. Zaldivar R, Oscherow S, Piezzi V. Bioptics in phakic and
pseudophakic intraocular lens with the Nidek EC-5000
excimer laser. J Refract Surg. 2002;18(3 Suppl):S336-S339.
8. Ayala MJ, Perez-Santonja JJ, Artola A, Claramonte P, Alio
JL. Laser in situ keratomileusis to correct residual myopia
after cataract surgery. J Refract Surg. 2001;17(1):12-16.
9. Donnenfeld ED, Solomon R, Biser S. Laser in situ ker-
atomileusis after penetrating keratoplasty. Int Ophthalmol
Clin. 2002;42(4):67-87.
10. Probst LE, Smith T. Combined refractive lensectomy and
laser in situ keratomileusis to correct extreme myopia.
J Cataract Refract Surg. 2001;27(4):632-635.
11. Zaldivar R, Davidorf JM, Oscherow S, Ricur G, Piezzi V.
Combined posterior chamber phakic intraocular lens and
laser in situ keratomileusis: bioptics for extreme myopia.
J Refract Surg. 1999;15(3):299-308.
12. Bilgihan K, Ozdek SC, Akata F, Hasanreisoglu B.
Photorefractive keratectomy for post-penetrating kerato-
plasty myopia and astigmatism. J Cataract Refract Surg.
2000;26(11):1590-1595.
78 Chapter 8
13. Probst LE, Machat JJ. Conservative photorefractive keratec-
tomy for residual myopia following radial keratotomy. Can
J Ophthalmol. 1998;33(1):20-27.
14. Menezo JL, Cisneros AL, Rodriguez-Salvador V.
Endothelial study of iris-claw phakic lens: four year follow-
up. J Cataract Refract Surg. 1998;24(8):1039-1049.
15. Rao SN, Raviv T, Majmudar PA, Epstein RJ. Role of
Orbscan II in screening keratoconus suspects before refrac-
tive corneal surgery. Ophthalmology. 2002;109(9):1642-
1646.
16. Foss AJ, Rosen PH, Cooling RJ. Retinal detachment follow-
ing anterior chamber lens implantation for the correction of
ultra-high myopia in phakic eyes. Br J Ophthalmol.
1993;77(4):212-213.
17. Giaconi J, Pham R, Ta CN. Bilateral Mycobacterium absces-
sus keratitis after laser in situ keratomileusis. J Cataract
Refract Surg. 2002;28(5):887-890.
18. Wilson SE, Ambrosio R. Laser in situ keratomileusis-
induced neurotrophic epitheliopathy. Am J Ophthalmol.
2001;132(3):405-406.
19. Balazsi G, Mullie M, Lasswell L, Lee PA, Duh YJ. Laser in
situ keratomileusis with a scanning excimer laser for the cor-
rection of low to moderate myopia with and without astig-
matism. J Cataract Refract Surg. 2001;27(12):1942-1951.
20. Zaldivar R, Davidorf JM, Oscherow S. Laser in situ ker-
atomileusis for myopia from -5.50 to -11.50 diopters with
astigmatism. J Refract Surg. 1998;14(1):19-25.
21. Baïkoff G, Arne JL, Bokobza Y, et al. Angle-fixated anterior
chamber phakic intraocular lens for myopia of -7 to -19
diopters. J Refract Surg. 1998;14(3):282-293.
22. Landesz M, Worst JG, van Rij G. Long-term results of cor-
rection of high myopia with an iris-claw phakic intraocular
lens. J Refract Surg. 2000;16(3):310-316.
23. Zaldivar R, Davidorf JM, Oscherow S. Posterior chamber
phakic intraocular lens for myopia of -8 to -19 diopters.
J Refract Surg. 1998;14(3):294-305.
24. Zaldivar R, Davidorf JM, Oscherow S, Ricur G, Piezzi V.
Combined posterior chamber phakic intraocular lens and
laser in situ keratomileusis: bioptics for extreme myopia.
J Refract Surg. 1999;15(3):299-308.
25. Guell JL, Vazquez M, Gris O. Adjustable refractive surgery:
6-mm Artisan lens plus laser in situ keratomileusis for the
correction of high myopia. Ophthalmology. 2001;108(5):
945-952.
26. Malecaze FJ, Hulin H, Bierer P, et al. A randomized paired
eye comparison of two techniques for treating moderately
high myopia: LASIK and artisan phakic lens.
Ophthalmology. 2002;109(9):1622-1630.
27. El Danasoury MA, El Maghraby A, Gamali TO.
Comparison of iris-fixed Artisan lens implantation with
excimer laser in situ keratomileusis in correcting myopia
between -9.00 and -19.50 diopters: a randomized study.
Ophthalmology. 2002;109(5):955-964.
28. Vukich JA. Phakic IOL's and LASIK: comparison of visual
outcomes in high myopia. Paper presented at the ISRS pre-
American Academy of Ophthalmology meeting; October
18, 2003; Orlando, Fla.
29. Budo C, Hessloehl JC, Izak M, et al. Multicenter study of
the Artisan phakic intraocular lens. J Cataract Refract Surg.
2000;26(8):1163-1171.
30. Jacobs JM, Taravella MJ. Incidence of intraoperative flap
complications in laser in situ keratomileusis. J Cataract
Refract Surg. 2002;28(1):23-28
31. Recep OF, Cagil N, Hasiripi H. Outcome of flap subluxa-
tion after laser in situ keratomileusis: results of 6 month fol-
low-up. J Cataract Refract Surg. 2000;26(8):1158-1162.
32. Pushker N, Dada T, Sony P, Ray M, Agarwal T, Vajpayee
RB. Microbial keratitis after laser in situ keratomileusis.
J Refract Surg. 2002;18(3):280-286.
33. Pallikaris IG, Kymionis GD, Astyrakakis NI. Corneal ectasia
induced by laser in situ keratomileusis. J Cataract Refract
Surg. 2001;27(11):1796-1802.
34. Tekwani NH, Huang D. Risk factors for intraoperative
epithelial defect in laser in-situ keratomileusis. Am J
Ophthalmol. 2002;134(3):311-316.
35. Wang MY, Maloney RK. Epithelial ingrowth after laser in
situ keratomileusis. Am J Ophthalmol. 2000;129(6):746-
751.
36. Balazsi G, Mullie M, Lasswell L, Lee PA, Duh YJ. Laser in
situ keratomileusis with a scanning excimer laser for the cor-
rection of low to moderate myopia with and without astig-
matism. J Cataract Refract Surg. 2001;27(12):1942-1951.
37. Azar DT, Yeh PC. Corneal topographic evaluation of
decentration in photorefractive keratectomy: treatment dis-
placement vs intraoperative drift. Am J Ophthalmol.
1997;124(3):312-320.
38. Tsai YY, Lin JM. Natural history of central islands after laser
in situ keratomileusis. J Cataract Refract Surg. 2000;26(6):
853-858.
39. Allemann N, Chamon W, Tanaka HM, et al. Myopic angle-
supported intraocular lenses: two-year follow-up.
Ophthalmology. 2000;107(8):1549-1554.
40. Landesz M, Worst JG, van Rij G. Long-term results of cor-
rection of high myopia with an iris-claw phakic intraocular
lens. J Refract Surg. 2000;16(3):310-316.
41. Alio JL, Mulet ME, Shalaby AM. Artisan phakic iris-claw
intraocular lens for high primary and secondary hyperopia.
J Refract Surg. 2002;18(6):697-707.
42. Yoon H, Macaluso DC, Moshirfar M, Lundergan M.
Traumatic dislocation of an Ophtec Artisan phakic intraoc-
ular lens. J Refract Surg. 2002;18(4):481-483.
43. Maloney RK, Nguyen LH, John ME. Artisan phakic intraoc-
ular lens for myopia: short-term results of a prospective, mul-
ticenter study. Ophthalmology. 2002;109(9):1631-1641.
44. Sanders DR, Vukich JA. Incidence of lens opacities and clin-
ically significant cataracts with the implantable contact lens:
comparison of two lens designs. J Refract Surg.
2002;18(6):673-682.
 Comparison of Phakic Intraocular Lenses With Corneal Refractive Surgery
45. Dejaco-Ruhswurm I, Scholz U, Pieh S, et al. Long-term
endothelial changes in phakic eyes with posterior chamber
intraocular lenses. J Cataract Refract Surg. 2002;28(9):1589-
1593.
46. Trindade F, Pereira F, Cronemberger S. Ultrasound biomi-
croscopic imaging of posterior chamber phakic intraocular
lens. J Refract Surg. 1998;14(5):497-503.
47. Davidorf JM, Zaldivar R, Oscherow S. Posterior chamber
phakic intraocular lens for hyperopia of +4 to +11 diopters.
J Refract Surg. 1998;14(3):306-311.
79
48. Gonvers M, Othenin-Girard P, Bornet C, Sickenberg M.
Implantable contact lens for moderate to high myopia:
short-term follow-up of 2 models. J Cataract Refract Surg.
2001;27(3):380-388.
49. Abela-Formanek C, Kruger AJ, Dejaco-Ruhswurm I, Pieh S,
Skorpik C. Gonioscopic changes after implantation of a
posterior chamber lens in phakic myopic eyes. J Cataract
Refract Surg. 2001;27(12):1919-1925.
50. Zaldivar R, Davidorf JM, Oscherow S. Posterior chamber
phakic intraocular lens for myopia of -8 to -19 diopters.
J Refract Surg. 1998;14(3):294-305.

Complications of
Phakic Intraocular Lenses
Thomas Kohnen, MD; Alireza Mirshahi, MD; Jens Bühren, MD;
Thomas Kasper, MD; and Martin Baumeister, MD
INTRODUCTION
The implantation of intraocular lenses (IOLs) into the
human eye reached its 50th anniversary in 1999. Looking
back to the various IOLs implanted into the anterior or
posterior chamber, we are aware of various complications
associated with different IOL designs, materials, and posi-
tions. These complications can be short- or long-term.
The implantation of IOLs in the phakic eye (phakic
IOLs) is a relatively new technique to correct primarily
high ametropia. The time lapse between introduction of
new lens designs is short, thus surgeon’s experience with
one specific lens is back to zero when new lenses are pre-
sented that overcome a specific complication, but keep in
mind, however, that new problems inevitably arise.1
Currently, only a few long-term studies are available with
phakic IOLs, thus regular reassessment of the complica-
tion spectrum is necessary, as new studies will be pub-
lished. Complications of phakic IOLs documented in the
literature as well as those encountered in the authors’ own
experiences are summarized and discussed in this chapter.
ANTERIOR CHAMBER
ANGLE-SUPPORTED
PHAKIC INTRAOCULAR LENSES
The certain complication spectrum of angle-supported
anterior chamber phakic IOLs (AC phakic IOLs), which
were mainly developed by Baïkoff from France, is related
to their design as they are positioned in the anterior cham-
9
Chapter
ber where there is potential risk for damage to the
endothelium, and as they are supported in the sclero-
corneal angle with possible damage to the angle and iris
(pupillary block, pupil ovalization, chronic uveitis).
Positioning the phakic lens away from the crystalline lens
might reduce the risk of cataract formation compared to
posterior chamber phakic IOLs. Below, specific complica-
tions of the angle-supported AC phakic IOLs are dis-
cussed.
Endothelial Cell Loss and
Anterior Chamber Depth
The main concern about AC phakic IOLs is loss or dam-
age to the endothelial integrity. An exact preoperative
examination should exclude those patients with low
endothelial cell count or those with shallow anterior cham-
bers because the risk of cell loss increases as the distance
between phakic IOL and the endothelium decreases. A
7-year follow-up study by Alió et al reports on an early post-
operative loss of endothelial density of 38%, gradually
decreasing to about 0.5% per year after the second postop-
erative year.2 In this study, the Chiron ZB 5M/ZB 5MF
(Chiron, Claremont, Calif) was investigated for 7 years and
the Morcher ZSAL-4 (Morcher GmbH, Stuttgart,
Germany) for only 4 years. The total percentage of
endothelial loss over 7 years was 8.4%. Other studies have
confirmed the initial significant loss of endothelial cell and
reduction of this tendency in the second postoperative
year.3-5 Alleman et al found a 12% loss for the Bausch &
Lomb NuVita (Rochester, NY) at 2 years. Baïkoff et al found
a 4.8% loss at 3 years with the ZB 5M, and Perez-Santonja
82 Chapter 9
Figure 9-1A. Deposits on AC phakic IOL. Protein deposits on AC
phakic IOL 1 month postoperatively (34-year-old female).
et al found a 4.2% loss with the Morcher ZSAL-4. All of
these AC phakic IOLs were polymethylmethacrylate
(PMMA) rigid IOLs. The numbers are not yet published for
the new flexible AC phakic IOLs, such as the CIBA Vision
Vivarte (foldable optic with PMMA haptics) (CIBA Vision,
Atlanta, Ga) or the Alcon foldable AC phakic IOL
(hydrophobic acrylate) (Alcon Surgical, Fort Worth, Tex).
However, meticulous long-term follow-up of each patient is
at the moment necessary for any AC phakic IOL to detect
those individuals with significant damage to the endotheli-
um and to explant the phakic IOL whenever clinically nec-
essary.
Pigment Dispersion
and Lens Deposits
Although no definite incidence for these conditions is
reported in the literature, these conditions are seen in clin-
ical practice (Figure 9-1A). They normally do not nega-
tively affect visual acuity and thus no further procedure—
except for regular clinical observation—is necessary.
Surgical intervention might be necessary in single individ-
ual cases. Besides pigment dispersion, intraoperative hem-
orrhage (Figure 9-1B) may lead to erythrocyte deposits on
the IOL and intraocular pressure (IOP) elevation. The
bleeding either originates from vessels in the scleral tunnel
or from the intraoperative iridectomy.
Chronic Inflammation and Uveitis
As the angle-supported AC phakic IOL is positioned
directly in front of the iris, chronic inflammation and pig-
ment dispersion are possible, as the pupil movement might
induce some friction with the IOL. Perez-Santonja et al
reported on two of 23 treated eyes presenting with slight
chronic inflammation during the first 6 months.5 Allemann
Figure 9-1B. Deposits on AC phakic IOL.
Anterior chamber hemorrhage after AC phakic
IOL implantation (courtesy of E. Rosen,
Manchester, Great Britain).
et al removed one of the 21 implanted IOLs due to a
chronic postoperative inflammatory response associated
with ocular hypertension.3 Alió et al observed acute post-
operative iritis in 4.6% of 263 AC phakic IOLs.2 As with
other complications, if the conservative treatment does
not succeed, lens removal should be considered to avoid
long-term risk to the vision.
Pupil Ovalization and Iris Retraction
Ovalization of the pupil is a specific complication of
angle-AC phakic IOLs (Figures 9-2A and 9-2B). The posi-
tion of haptics in the sclerocorneal angle and their size
might lead to mild deformation of the iridosclerocorneal
architecture, resulting in iris retraction and pupil ovaliza-
tion. Mild to medium deformation of pupil shape (see
Figure 9-2A) as reported by Alió et al in 10.3% of their
large series of 263 eyes2 does not affect the refractive, the
cosmetic, or the optical results of the surgery. Severe oval-
ization causes glare and is unacceptable from a cosmetic
point of view (see Figure 9-2B). Alió et al observed this
condition in 5.9%, which led to lens explantation in two
cases. Allemann and coworkers reported eight oval pupils
(>0.5 mm) in a series of 21 eyes.3 Perez-Santonja et al
observed four cases in a series of 23 eyes.5
Iris retraction with oval pupil deformation remains a
concern of the angle-supported phakic IOLs. This matter,
together with potential damage to endothelial cells, is the
major objection against the current lens designs. Topical
use of miotic agents should be considered in the early
postoperative phase if pupil ovalization associated with
glare is detected.
Intraocular Lens Rotation
Rotation of the angle-supported phakic IOLs might
occur due to undersizing. In fact, Allemann et al report
that 80% of eyes showed greater than 15 degrees of rota-

Figure 9-2A. Pupil ovalization following AC phakic IOL
implantation. Moderate ovalization.2
tion in 2 years, and 60% had rotated between years 1 and
2, implying some instability in the anterior chamber.3
Perez-Santonja observed rotation in 43.5% of 23 treated
eyes.5
Induced Astigmatism
Surgically induced astigmatism is of significance
because patients request acceptable unaided postoperative
visual acuity. The surgeon needs to consider the preoper-
ative amount and axis of astigmatism in order to decide
whether to use a 5 to 6 mm incision size with a PMMA
lens (eg, Phakic 6 [Ophthalmic Innovation International
Inc, Ontario, Canada]) or to implant a foldable phakic
IOL (eg, Vivarte) through a small incision. If a significant
astigmatism is induced by the surgery, further refractive
surgical procedures (eg, suture revision or removal, limbal
relaxing incisions, or even excimer laser surgery) might be
considered.
Glare and Halos
One disadvantage of AC phakic IOLs is that they are
positioned in front of the pupil, with edge effects as a
potential source of optical aberrations. Furthermore, the
relation of pupil size and center to the optic of the lens is a
crucial factor that should be evaluated and discussed pre-
operatively. Sometimes the AC phakic IOL optic center
and the pupil center are not coincident. In cases in which
the scotopic pupil size is significantly larger than the optic
of the lens, the surgeon should be very cautious with the
implantation of phakic IOLs because this will probably
result in postoperative glare and subjective discomfort. The
incidence of glare is dependent on the size of the optic,
which varies in different lens designs and generations. The
acceptable relationship between AC phakic IOL optic and
scotopic pupil size remains to be determined. Incidence of
glare and halos is reported in the literature to be between
10% at the 7-year follow-up2 and 80% as observed by
Allemann and coworkers.3 However, in a recent study, the
Complications of Phakic Intraocular Lenses 83
Figure 9-2B. Pupil ovalization following AC phakic IOL
implantation. Severe “cat pupil”-like ovalization.2
NuVita IOL had a special optic edge design to prevent
glare. A study performed by Maroccos et al showed that all
tested phakic IOLs (ie, NuVita, Artisan, Implantable
Contact Lens [ICL] [STAAR Surgical AG, Nidau,
Switzerland]), in particular ICL (posterior chamber phakic
IOL) and NuVita (angle-supported AC phakic IOL), lead
to a decreased visual performance during night time due to
glare and halos.6 Topical use of miotic agents should be
considered in the early postoperative phase if the patient
feels disturbed by these phenomena.
Glaucoma
The risk of acute angle glaucoma is well known from
aphakic anterior chamber IOLs; therefore, a peripheral iri-
dectomy is recommended for this IOL. With phakic angle-
supported anterior chamber IOLs, the risk will not be less,
particularly because the continuously growing natural lens
is still in the eye. Ardjomand et al observed one case of
pupillary block after implantation of an angle-supported
AC phakic IOL that was successfully treated with
neodymium:yttrium-aluminum-garnet (Nd:YAG) iridoto-
my.7 The authors recommend two very important steps to
prevent the potential complication of acute angle glauco-
ma for angle-supported and other types of phakic IOLs:
1. Removal of all viscoelastic substance from the anterior
segment at the end of the procedure is mandatory. A
coadhesive viscoelastic substance like Healon
(Pharmacia, New York, NY) is the authors’ preference
2. The authors recommend preoperative iridotomy, as
performed by most surgeons, by means of Nd:YAG
laser or intraoperative iridectomy with scissors or
vitrector cutters to forestall acute pupillary block
glaucoma
Particularly with foldable angle-supported phakic IOLs,
the need for a peripheral iridectomy has been discussed
amongst experienced refractive intraocular surgeons.
However, only long-term experience will show if surgeons
can abandon this important step of the procedure.
84 Chapter 9
Figure 9-3. Nuclear cataract in an eye with an AC phakic IOL
(courtesy of Jorge L. Alió,Alicante, Spain).
Figure 9-5. After AC phakic IOL implantation (Bausch &
Lomb, NuVita lens), diagnostic mydriasis is possible (33-
year-old female).
Other factors of postoperative elevated IOP may be
due to steroid medication, which should be carefully
observed and treated with conversion to nonsteroidal anti-
inflammatory drugs, if still necessary, and topical antiglau-
comatous medication.
If a chronic IOP elevation develops otherwise, the
angle needs to be examined for synechia formation and
other pathologies, and IOL removal should be considered
when necessary.
Cataract Formation
As the AC phakic IOL is positioned away from the lens,
cataract formation is of less significance when compared
to posterior chamber phakic IOLs. Because cataract for-
mation in the highly myopic, who represent the vast
majority of the treated patients, is more frequent than in
the general population, discriminating between a myopia-
associated cataract and a surgically-triggered or hastened
cataract is difficult (Figure 9-3). Alió et al reported on nine
cataract removals during the 7-year follow-up of 263 eyes
Figure 9-4. Endophthalmitis after AC phakic IOL implanta-
tion (courtesy of Jorge L. Alió,Alicante, Spain).
(3.4%).2 All cataracts were nuclear and the calculated
Kaplan-Meier survival curves for cataract development
show that more than 90% of subjects would be expected
to remain cataract free after 98 months.
General Risks of Intraocular
Procedures and Vitreoretinal
Procedures
Implantation of phakic IOLs is an intraocular procedure
with potential risk of endophthalmitis (Figure 9-4), as in
every intraocular surgery. Preoperative use of antibiotics,
intraoperative care sterility, and meticulous postoperative
follow-up examinations may help to prevent this severe
complication and to treat it as early and as aggressively as
possible. Only a few vitreoretinal complications have been
reported after implantation of phakic IOLs.8,9 Exact pre-
operative and regular postoperative examination of the
posterior segment by indirect ophthalmoscopy or
Goldmann 3-mirror lens will help to detect and treat reti-
nal breaks in this patient group, which is in danger of vit-
reoretinal pathologic conditions because of severe myopia
in most cases. In the authors’ experience, sufficient pupil
dilation for retinal examination without any risk of pupil
deformation or IOL decentration is feasible following AC
phakic IOL implantation (Figure 9-5).
IRIS-FIXATED ANTERIOR CHAMBER
PHAKIC INTRAOCULAR LENSES
The iris-fixated IOL is marketed in Europe as the Artisan
(Ophtec BV, Groningen, Netherlands) and outside Europe
as the Verisyse (Advanced Medical Optics, Irvine, Calif).
The “lobster-claw“ design has been used since 1978 for
pseudophakic IOLs, mainly for secondary implantation in
aphakic eyes.10 Since 1986, the Worst-Fechner IOL has
been implanted in phakic eyes for the correction of high

Figure 9-6A. First generation iris-claw lens (Worst-Fechner), 11
years after implantation (61-year-old female). Slit lamp image.
Note the slight decentration.
myopia and subsequently hyperopia (Figure 9-6A).11 The
original design was modified in 1991 to assure a sufficient
vault between the IOL optic and the iris. This IOL design
bears potential risks to the corneal endothelium, a problem
that is common for all AC IOLs. Another concern is the fix-
ation in the sensitive iris tissue, which has the potential to
cause pigment dispersion or intraocular inflammation as
well as decentration or deformation of the pupil.
Endothelial Cell Loss
and Anterior Chamber Depth
Damage to the endothelium can occur mostly because
of the IOL’s direct contact with the inner surface of the
cornea, either during implantation or by postoperative
changes in IOL position. Another possibility for postoper-
ative endothelial damage may be subclinical inflammation
with direct toxicity to the endothelium.
In 1991, Fechner et al described the first results of this
lens after a 12-month follow-up.12 Five of 109 eyes suf-
fered endothelial cell loss by surgical trauma and five eyes
had progressive endothelial cell loss that caused corneal
edema in one eye (Figure 9-6B).
Menezo et al examined the influence on the corneal
endothelium of 111 eyes over 4 years in a prospective
study.13 They found the largest percentage of cell loss in
the first 6 months after implantation and concluded that
the main cause for endothelial cell loss is surgical trauma.
Endothelial cell pleomorphism and polymegathism did
not change significantly after surgery. One phakic IOL
that was placed too superiorly caused corneal edema and
had to be removed. Other studies yielded similar
results.14-17 Maloney et al found no difference in mean
Complications of Phakic Intraocular Lenses 85
Figure 9-6B. First generation iris-claw lens (Worst-Fechner),
11 years after implantation (61-year-old female). The confo-
cal microscopic image of the endothelium reveals severe
endothelial cell loss (700 cells/mm2).
endothelial cell count between the preoperative state and
6 months postoperatively.18
In contrast to these findings, Perez-Santonja et al
reported continuous endothelial cell loss with a decrease
of 17.6% 24 months after surgery.19 All authors agree that
preoperative endothelial microscopy is mandatory.
Patients with endothelial damage or an endothelial cell
count below 2000 cells/mm2 should not receive an AC
phakic IOL.
The height of the Artisan lens and the potential close-
ness to the cornea increase with the dioptric power.
Therefore, a sufficient anterior chamber depth (ACD) for
the calculated IOL is necessary. The distance between the
implant and the corneal endothelium should not be less
than 1.5 mm.
Pigment Dispersion and Lens Deposits
The optic of the iris-claw phakic IOL is vaulted anteri-
orly to prevent iris chafing. Pop et al performed postoper-
ative ultrasonic biomicroscopy of the IOL haptics of
myopic and hyperopic phakic IOLs and found no evidence
for irritation of the iris pigment epithelium by the IOL
haptics within a follow-up period of 24 to 371 days.20,21
Occasionally, pigment cells are visible on the IOL optic in
the early postoperative period due to surgical trauma
(Figures 9-7A and 9-7B), but as of the writing of this text,
there is no evidence of chronic pigment dispersion or pig-
ment glaucoma as a typical complication of this type of
phakic IOL. However, in the US Food and Drug
Administration Phase III trial for the hyperopic iris-claw
phakic IOL, there were reports of three patients who had
pigment dispersion or pupillary membrane formation due
to iris touch.1 This may be a problem more for the hyper-
opic than the myopic iris-claw phakic IOL.
86 Chapter 9
Figure 9-7A. Iris pigment defects at the site of enclavation may
be one source for dispersed iris pigment (30-year-old male).
Figure 9-8A. Inflammatory reaction after iris-claw lens
implantation. Dense fibrin coating of the phakic IOL
1 week postoperatively (34-year-old female).
Chronic Inflammation and Uveitis
The possibility of chronic inflammation has always
been a major concern with the iris-claw lens, as this IOL is
fixated directly in the iris tissue and causes pressure or
shear forces when the eye is moving (Figures 9-8A and
9-8B). This could lead to injury or increased permeability
of the iris vessels with breakdown of the blood-aqueous
barrier and chronic release of inflammatory mediators.
This has been repeatedly examined using different tech-
nologies. Two studies that were performed using iris
angiography showed no leakage of the iris vessels.12,22
Studies conducted using a laser-flare cell meter came to
diverging results. Fechner et al12 found no elevated flare
levels in 109 eyes with at least 12 months of follow-up.
Perez-Santonja et al found elevated flare levels compared
to a normal population in 30 eyes at 12, 18, and 24 months
after surgery.23 Gross et al found no significantly elevated
flare after 6 months17 in a study with 44 eyes. In all of the
studies, clinically relevant inflammation could only be
Figure 9-7B. Iris pigment defects at the site of enclavation may
be one source for dispersed iris pigment (47-year-old female).
Both A and B are 3 months postoperatively.
Figure 9-8B. Inflammatory reaction after iris-claw lens
implantation. Persistent deposits 3 months after implanta-
tion (37-year-old male).
detected in individual cases. Nevertheless, careful postop-
erative monitoring of inflammatory signs is necessary. If
persistent intraocular inflammation occurs that is not suffi-
ciently treatable with drugs, the removal of the implant
must be considered.
Pupil Ovalization and Decentration
Pupil ovalization or irregularity can occur if the fixation
of the haptics is performed asymmetrically. No progres-
sive pupil ovalization has been reported so far. Maloney et
al report pupil irregularities in 14.0% of 130 eyes on the
first day after surgery and 1.2% of 84 eyes after
6 months.18 As the enclavation is performed in the periph-
eral iris, pupil dilatation is limited after implantation of the
IOL. However, the authors have been able to perform reg-
ular fundus examination in all eyes with phakic iris-fixated
IOLs (Figures 9-9A and 9-9B).

Figure 9-9A. After iris-claw AC phakic IOL implantation (Artisan/
Verisyse), diagnostic mydriasis is possible (25-year-old female)
12 months after implantation.
Figure 9-10. Traumatic dislocation of an iris-claw AC
phakic IOL (courtesy of D. Annen, Switzerland).
The Artisan/Verisyse phakic IOLs are centered on the
pupil. This can lead to difficulties if the pupil itself is
decentered and if the optical axis is not in the middle of
the pupil (see Figure 9-6A). Postoperative decentration is
possible if the enclavation is not sufficient. Menezo et al
report 13.5% decentration, but only one case in which a
second intervention was necessary due to double vision.22
Perez-Santonja et al found a decentration greater than
0.5 mm in 43% of the examined eyes.19 Perez-Torregrosa
et al found a mean decentration of 0.47 with respect to the
pupil center in 22 eyes using a digital imaging system.24 If
the IOL is fixated properly, no postoperative decentration
or rotation of the optic should occur. The authors recom-
mend performing the enclavation step of the operation in
a physiological situation (ie, the anterior chamber is not
too flat and not too deep).
Postoperative dislocations due to blunt ocular trauma
have been described (Figure 9-10).18,25 In the authors’
experience, they observed only one case of possible pha-
kic IOL dislocation in a patient with very thin iris tissue.
Complications of Phakic Intraocular Lenses 87
Figure 9-9B. After iris-claw AC phakic IOL implantation
(Artisan/Verisyse), diagnostic mydriasis is possible (24-year-
old male) 3 months after implantation.
However, before the IOL could have been completely dis-
located, a second intervention was performed and the iris
enclavation was repeated with more iris tissue. This phakic
IOL has been stable in the eye for more than 6 months.
Intraocular Lens Rotation
Rotation of iris-fixated phakic IOLs is not expected due
to the permanent enclavation in the iris tissue and it has
not been described. Therefore, this design is particularly
interesting for toric phakic IOL designs.
Induced Astigmatism
Because the iris-claw lens is not foldable, it requires an
incision that approximately equals the optic diameter (5.0
or 6.0 mm). This is likely to induce postoperative astigma-
tism (Figure 9-11A to 9-11C). There are several ways of
influencing postoperative astigmatism: incision on the steep
corneal meridian; use of clear corneal, posterior limbal, or
scleral tunnel incisions (Figures 9-12A to 9-12C); adjust-
ment of the sutures during surgery; or selective suture
removal after surgery. According to the literature, surgically
induced astigmatism is less than one might expect. Menezo
et al found no significant increase of postoperative astigma-
tism.22 Alió et al15 found a mean induced astigmatism of
1.48 ⫾ 0.89 D for the hyperopic Artisan IOL with correc-
tion of primary hyperopia and 1.85 ⫾ 1.19 D with correc-
tion of secondary hyperopia after corneal refractive surgery.
Maloney et al reported a mean decrease in astigmatism of
0.3 D after 6 months.18 In the authors’ experience, the
induced astigmatism for the Artisan IOL implanted through
a 6-mm superior posterior limbal incision was 1.93 ⫾ 0.49
D.26 Therefore, we currently adjust our incision according
to the preoperative astigmatism. The introduction of fold-
able models of the iris-claw lens could further reduce the
amount of induced astigmatism. With the toric models,
larger amount of astigmatism can be managed.
88 Chapter 9

Figure 9-11A. Induction of corneal astigmatism due to a 6-mm Figure 9-11B. Induction of corneal astigmatism due to a 6-mm
superior limbal incision (35-year-old male). Preoperative topog- superior limbal incision (35-year-old male). Corneal topography
raphy. 1 week postoperatively.

Figure 9-11C. Induction of corneal astigmatism due to a 6-mm

superior limbal incision (35-year-old male).
Figure 9-12A. Six-mm superior limbal incision for iris-claw lens
implantation (36-year-old male).

Figure 9-12B. The scleral tunnel helps to avoid induction of

corneal astigmatism (36-year-old male). Figure 9-12C. Loosening of sutures and induction of pannus
tissue 3 months after implantation of an iris-claw lens (47-
year-old female).

Figure 9-13A. Different optic diameters of the iris fixated AC pha-
kic IOL (30-year-old male), 5-mm optic in the right eye (17 D).
Glare and Halos
Phakic IOLs are often implanted in eyes of compara-
tively young patients with a large scotopic pupil diameter.
This can result in glare phenomena if the pupil is larger
than the IOL optic. A study conducted by Maroccos et al6
showed significantly less glare and smaller halos for the
Artisan IOL than for other phakic IOLs, especially for the
6.0-mm optic. This was attributed to the larger IOL optic
(6 mm vs 5 mm) and the fixation of the IOL in the iris,
which causes less dilation of the pupil. Therefore, the
6.0-mm optic iris-fixated phakic IOL seems to be prefer-
able over the 5.0-mm optic. Unfortunately, this is not
always possible due to the greater thickness of these optics
and possible damage to the corneal endothelium in a given
ACD (Figures 9-13A and 9-13B). The power of the
6.0-mm optic is -15.5 D for myopia. For hyperopia the
range is +1.0 to +12.0 for both optic types. Landesz et al
report two of 38 patients that required pilocarpine eye
drops because of halos after implantation of the 5.0-mm
optic Artisan lens.16 Maloney et al recorded mild to mod-
erate glare in 18 eyes (13.8%) and severe glare in one eye
(0.8%) of 130. A lens with 5.0-mm optic was exchanged
for a lens with 6.0-mm optic in three eyes, with no further
glare noticed afterward.18
Glaucoma
Because the anterior chamber angle is not affected by
the haptics of the iris-claw IOL, lens size-related second-
ary glaucoma is not practically possible. A peripheral iri-
dectomy or iridotomy is necessary for the prevention of a
pupillary block. In several studies and in the authors’ expe-
rience, there were some cases of elevated IOP in the early
postoperative period that resolved without further damage
and were probably related to steroid medication.15,16,18,27
Complications of Phakic Intraocular Lenses 89
Figure 9-13B. Different optic diameters of the iris fixated AC
phakic IOL (30-year-old male), 6-mm optic in the left eye (12 D).
Cataract Formation
Cataract formation due to the iris-claw lens is very
unlikely because it is inserted over a miotic pupil without
contacting the crystalline lens. Until now, clinically rele-
vant cataract formation has not been reported in associa-
tion with the iris-claw lens. Perez-Santoja et al only
detected a loss of lens transmittance of 1.03% after 18
months by fluorophotometry that had no influence on
visual acuity.19
Other Complications
Menezo et al describe one case of permanent wide dila-
tion of the pupil causing decreased postoperative visual
acuity because of glare.22 Hyphema in the early postoper-
ative phase due to iris trauma is occasionally
described.16,18,22 Iris bleeding can also be caused by pre-
operative Argon or Nd:YAG laser treatment of the iris to
mark fixation points for the IOL enclavation.
As for all other intraocular procedures, every precau-
tion must be taken to avoid infectious endophthalmitis.
Likewise, thorough examination of the posterior segment
for vitreoretinal pathologies is mandatory, although there
have been no vitreoretinal complications with the iris-claw
lens reported so far.
POSTERIOR CHAMBER
PHAKIC INTRAOCULAR LENSES
Implantation of posterior chamber phakic intraocular
lenses (PC phakic IOLs) in phakic eyes has proven to be an
effective and predictable refractive technique for surgical
treatment of high myopia.28-30 In some cases, even high
hyperopic eyes can be treated with PC phakic IOLs.28,31
90 Chapter 9

A B
Figure 9-14. Cataract formation after implantation of PC phakic IOL. A. Faint anterior subcapsular opacities 12 months after implan-
tation (45-year-old female). B. Same eye as in A on retroillumination.

Figure 9-14D. Cataract formation after implantation

Figure 9-14C. Cataract formation after implan- of PC phakic IOL. Retroillumination of anterior sub-
tation of PC phakic IOL. Distinct anterior sub- capsular cataract in an eye with PC phakic IOL
capsular cataract in an eye with PC phakic IOL (courtesy of Jorge L. Alió,Alicante, Spain).
(courtesy of E. Rosen, England).

The specific complications of PC phakic IOLs are
caused by their position between the iris and the natural
lens. The most common complications—cataract forma-
tion (Figures 9-14A to 9-14D), pupillary block, and glau-
coma—are dependent on the lens position, material, and
original design, as well as the generation, of the different
models. In the following, specific complications of PC
phakic IOLs are discussed, especially for the ICL, the
Adatomed IOL (Chiron, Claremont, Calif), and the phakic
refractive lens (PRL) (CIBA Vision, Duluth, Ga).
Cataract Formation
Causative factors for cataract formation (see Figures 9-
14A to 9-14D) are lens materials, position, surgical trauma,
as well as lens design/generation.
After implantation of Adatomed IOLs, Brauweiler et al
reported 81.9% cataract formation after a follow-up of
2 years in which two of 17 eyes developed lens opacifica-
tion in the first 3 months after surgery.32 Fechner et al
observed cortical opacification in the optical axis if there
was no visible space between the Adatomed IOL and the
natural lens, whereas the lenses with visible vault remained
clear.33 The authors have recently examined one of these
patients 10 years after implantation, and the crystalline
lens was still clear (Figure 9-15). Another trigger that
Fechner described in cataract formation is touching the
natural lens while implanting the IOL. Because of this high
rate of cataract formation, the Adatomed IOL is no longer
in use.
In general, cataract appearance was more frequently
seen after Adatomed IOL than ICL implantation.27 In a
study of 124 eyes, none developed lens opacities due to
ICL implantation.29 Nevertheless, they found one eye that
developed subscribed peripheral lens opacification at the
place where Nd:YAG-iridectomy was performed preoper-
atively. Zadok et al reported one case of focal lens opaci-
fication under the Nd:YAG laser iridectomy site that did-

Figure 9-15. Silicone PC phakic IOL (Adatomed) 10 years after
implantation into a myopic eye. The crystalline lens is clear
because, most likely, a vault existed throughout the whole post-
operative period of time.
n’t enlarge after implantation of the ICL.34 Another study
showed two eyes in one patient with anterior subcapsular
cataractogenesis 1.5 years after ICL implantation.30 The
ICLs were removed and phacoemulsification with capsular
bag implantation of an IOL was performed in both eyes.
Also, Trindade et al observed anterior subcapsular cataract
formation in the eye of a 59-year-old patient 6 months
after implantation of an ICL.35 The surgery was unevent-
ful and atraumatic. With ultrasound biomicroscopy, they
were able to measure a central vault between the ICL and
the natural lens whereas in the mid-periphery, a contact
was present. Anterior subcapsular lens opacities developed
in the noncontact area. Therefore, they surmised that the
proximity of the ICL to the natural lens could lead to
metabolic disturbances, as well as pressure from the PC
phakic IOL on the anterior surface could trigger cataract
formation. Additionally, the age of the patient should be
taken into account, too. As a differential diagnosis of lens
opacities, residues of viscoelastic substances should be
considered, in particular if the opacity is seen in the early
postoperative period.
With various generations of the ICL, the appearance of
cataract formation is different. The less vaulted model V3
of the ICL caused higher incidence of cataract formation
than the newer models V4 and V5.27 With the V4 model
the recently published US FDA study showed an inci-
dence of 2.1% anterior subcapsular (AS) opacities, which
were seen in 11 of 523 eyes.36 To prevent cataract forma-
tion, it seems to be important to have a vault between the
PC phakic IOL and the lens. With ultrasound biomi-
croscopy, it was possible to measure a central vault after
implantation of ICLs, while in the midperiphery a lens-
IOL contact mostly existed.37-39 Also, size changes and
Complications of Phakic Intraocular Lenses 91
even loss of the central vault as well as changes of the loca-
tion and extension of the contact zone were measured
(Figures 9-16A to 9-16C).38,39 These findings would indi-
cate anterior-posterior shifts in position of the ICL. Such
shifts may be due to the flexibility of the IOL material,
which would allow the ICL to become deformed, perhaps
while iris movements or accommodation occurred.
Nevertheless, lens opacities did not influence visual acuity
in any of the examined eyes.
After implantation of the PRL, Hoyos et al observed
anterior cortical opacification in the immediate postoper-
ative examination in one eye. This opacification remained
stable until the 2-year follow-up. Therefore, the authors
suspect natural lens touch during surgery as a trigger.40
As of the writing of this text, the authors haven’t seen
any cataract formation after ICL and PRL implantation in
their patients, all of whom have been operated on by one
experienced surgeon. Nevertheless, especially with regard
to cataract formation, it is necessary to evaluate long-term
results over several years. Because of the long-term uncer-
tainty of cataract formation with phakic posterior chamber
lens implants, we currently implant PC phakic IOLs only
in eyes of middle-aged or elderly patients (30 to 50 years).
The implantation of a phakic IOL in older presbyopic
patients will only be performed in exceptions. The proce-
dure of choice in these patients is refractive lens exchange
with natural lens removal and posterior chamber implanta-
tion.
Pupillary Block, Acute Glaucoma,
and Malignant Glaucoma
Because of the PC phakic IOLs, the iris can be pushed
forward and narrow the anterior chamber angle, so a pupil-
lary block with acute glaucoma can appear, especially in
hyperopic eyes.29,31,38 This problem can be prevented by
creating an intraoperative surgical iridectomy or two pre-
operative Nd:YAG-laser iridotomies, respectively.29-32,37
In some cases, preoperative iridotomies closed themselves
over time, were too small, or were blocked by a PC phakic
IOL haptic. This caused acute glaucoma. A second irido-
tomy with the Nd:YAG-laser or a surgical iridectomy has
to be performed.29,30,40 In one case, pupillary block
appeared 1.5 years after PRL implantation because of obtu-
ration obstruction of the iridectomy with the PRL hap-
tic.40 After treatment with a second iridectomy, IOP in all
eyes normalized.
For hyperopic treatment, the preoperative iridotomy is
even more important in preventing early pupillary block.
It is necessary to make two peripheral and sufficient sized
iridotomies with the Nd:YAG-laser or surgical procedure,
respectively.31
Kodjikian et al reported one case of malignant glauco-
ma with an IOP of 54 mmHg 3 days after ICL implanta-
92 Chapter 9
Figure 9-16A. Contact between the PC phakic IOL and the crys-
talline lens. Myopic ICL, slit lamp image. Note the delicate
opacities in the lower hemisphere (40-year-old male).
Figure 9-16C. Contact between the PC phakic IOL and
the crystalline lens. Hyperopic ICL, Scheimpflug image.
tion to treat myopia.41 Both iridotomies, which were done
preoperatively with a Nd:YAG-laser, were patent and
seemed large enough. The iris was not bowed forward and
the posterior segment did not have any pathology.
Therefore, acute glaucoma due to pupillary block was
ruled out. IOP still remained 50 mmHg despite medical
treatment, so that 5 days after the implantation an explan-
tation of the ICL had to be performed. After this, IOP
normalized without medical treatment and BCVA with a
contact lens was 20/25.
Intraocular Pressure Rise, Pigment
Dispersion, and Secondary Glaucoma
Menezo et al observed a slight increase of IOP after
implantation of PC phakic IOLs (1.5 mmHg after ICL, 2.3
mmHg after Adatomed implantation) over a follow-up of
18 months.27 In contrast, other studies with ICL or PRL
found only significantly increased IOP in some rare cases
after 1 month post-ICL implantation. When postoperative
steroid treatment was completed, IOP in all patients was
totally normalized.29,38,40
Figure 9-16B. Contact between the PC phakic IOL and
the crystalline lens. Myopic ICL, Scheimpflug image.
Zaldivar et al reported two of 124 eyes that showed
IOL-related IOP spikes. One of these eyes with a decen-
tered ICL had excessive pigment deposition on the phakic
IOL surface. It remained unclear whether the pigment dis-
persion was related to the decentration or to the IOL itself.
The ICL had to be removed and phacoemulsification with
implantation of posterior IOL in the capsular bag was per-
formed in both eyes. Subsequently, IOP was well con-
trolled without medication.29
Although Jiménez-Alfaro et al observed contact of the
ICL and the posterior iris in 100% of ultrasound biomi-
croscopy, they did not find pigment dispersion.38 The
authors suggest that the similarity between the ICL-
Collamer (STAAR Surgical, Monrovia, Calif) and the
anterior capsule of the natural lens could prevent the
mechanical loss of pigment. In contrast, Menezo et al
observed pigment deposits on the IOLs (Figure 9-17A) in
more than 40% of PC phakic IOL implantations inde-
pendent of the lens type (ie, Adatomed IOL, ICL).27 They
suggested touch of the PC phakic IOL with the posterior
iris as the trigger for this phenomenon. Davidorf et al
found pigment deposition on the phakic IOL surface
appeared stable over time in all eyes and no pigment dis-
persion glaucoma occurred, so they suggest that pigment
dispersion was probably surgically related.31 Hoyos et al
observed one case of window defects of the iris and
increased angular pigmentation without raised IOP after
PRL implantation for hyperopic treatment (Figures 9-17B
and 9-17C).40 The explanation the authors suggested was
too shallow of an ACD of 2.8 mm. The patient is current-
ly under careful follow-up. According to this experience,
they demand a minimum cut-off ACD of 3.0 mm for PC
phakic IOL implantation.
In one eye after ICL implantation for hyperopic treat-
ment, Davidorf et al observed the development of a pro-
gressive secondary glaucoma due to neovascularization of
the angle.31 This complication developed despite repeated
laser iridotomies, two trabeculectomies, and removal of
the phakic IOL combined with phacoemulsification and
posterior chamber IOL implantation in the capsular bag.18
Eighteen months after the phakic IOL implantation, the

Figure 9-17A. Myopic ICL with deposits from the insertion for-
ceps and with pigment deposits, first postoperative day (40-year-
old male).
Figure 9-17C. Pigment dispersion after implantation of myopic
ICL, gonioscopic view, 3 months after implantation (53-year-old
male).
patient had lost three lines BCVA, and IOP was controlled
with multiple medications. Rosen et al reported another
hyperopic treatment with secondary glaucoma 6 weeks
postoperatively.28 Here, even surgical iridectomy failed to
deepen the anterior chamber, so that the removal of the
ICL, vitrectomy, and phacoemulsification with implanta-
tion of an IOL in the capsular bag had to be performed
6 weeks later.
Decentration, Rotation,
and Oversized Intraocular Lenses
Decentration occurred more often after Adatomed IOL
than ICL implantation.27 Preoperatively, it is necessary to
measure exact white-to-white diameter for choosing an
IOL with sufficient length to prevent decentration and
rotation.27,42 In a few cases, Menezo et al reported decen-
Complications of Phakic Intraocular Lenses 93
Figure 9-17B. Transillumination defect of the iris at the site of
surgical iridectomy, 1 month postoperatively (39-year-old male).
tration with an adequate IOL length in relationship to
corneal diameter.27 The consequences of decentration are
diplopia, glare, and perhaps pigment dispersion syndrome
because of mechanical trauma.29,31 In these cases, the
ICLs had to be recentered or exchanged for an ICL with
the correct diameter.
In a new study done over 12 months, Garcia-Feijoó et
al measured with ultrasound biomicroscopy rotation of
ICL in two cases.39 Although there was no decentration of
the optic, the authors suggested that the diameter of the
ICL was too small.
Also, decentration occurred after PRL implantation as
too small of an IOL diameter was chosen.40 After exchang-
ing the small PRL for a newer generation PRL with greater
diameter, no more decentration was observed.
Trindade et al reported the exchange of an ICL because
of oversized length of the ICL.43 Malpositioning with a
very great vault and undercorrection occurred because the
ICL was too long. Ten months after primary surgery, the
ICL was exchanged for a smaller ICL with higher power.
This procedure was uneventful, and the patient was satis-
fied with the final visual outcome. The authors suggested
carrying out accurate measurements of the corneal diame-
ter. The length of the ICL had to be calculated from this
diameter (addition of 0.5 mm to the horizontal white-to-
white diameter). The authors’ current research suggested
that the most accurate value of horizontal white-to-white
diameter can be determined by the IOL master (Zeiss,
Jena, Germany).44
Anterior Chamber Depth
and Endothelial Cell Loss
Because the iris was pushed forward, ACD decreased
after the implantation of PC phakic IOLs. In multiple stud-
94 Chapter 9
Figure 9-18. Central keratopathy after implantation of a PC pha-
kic IOL (folds of Descemet’s membrane and stromal edema) on
the first postoperative day (43-year-old male).
ies, it was possible to measure narrowing of ACD with
ultrasound biomicroscopy.37-39 But in contrast to the
implantation of AC phakic IOLs, Jimenez-Alfaro et al did
not observe a significantly progressive endothelial cell loss
after implantation of PC phakic IOLs. Nearly 5% of
endothelial cells were lost from the surgical procedure
itself.38
Davidorf et al31 reported one eye with excessive vault-
ing of a hyperopic ICL. Because of this, the ACD largely
decreased and the trabecular meshwork was not seen with
gonioscopy. Subsequently, after exchanging the ICL
through a properly sized model, the patient did well.31,45
Sometimes, namely in cases of complicated surgery,
significant keratopathy could be seen with foldable phakic
IOLs in the early postoperative period (Figure 9-18). Folds
in Descemet’s membrane and stromal edema will resolve
within the first few days following the implantation. If not,
significant endothelial trauma should be considered.
To prevent pupillary block with acute glaucoma and
long-term problems, the ACD should be at least 2.8 mm for
myopic and 3.0 mm for hyperopic patients, which excludes,
in the authors’ experience, more than two-thirds of the
higher hyperopic (>+4.0 D) patients for hyperopic ICLs.
Glare and Halos
The consequence of small optical diameter phakic IOLs
and decentration in relationship to pupil size is that glare
and halos may occur, especially at night; therefore,
patients have great difficulty driving at night. Menezo et
al reported a higher incidence of halos after Adatomed
than ICL implantation.27 After implantation of ICLs, glare
and halos increased significantly. For these complaints,
two explanations exist: decentration and/or too small of an
optical diameter in relationship to pupil size. Several stud-
ies reported glare and diplopia in eyes with decentration of
the ICL greater than 1 mm.29,31 Maroccos et al observed a
high increase of postoperative glare and halos after ICL
implantation compared to Artisan implantation into the
anterior chamber.7 They explained these findings as being
due to the edge effects of the small diameter of the whole
ICL and the small optical diameter (4.5 to 5.5 mm) in rela-
tionship to the pupil size of the patients (5.3 to 7.4 mm).
After PRL implantation, 25% of 31 patients reported halos
and night glare.40 Because the PRL has an optical zone size
of 4.5 to 5.0 mm, it has the same etiology of glare and
halos than as after ICL implantation.
To avoid this complication it is very important to meas-
ure preoperative pupil size during mesopic lighting condi-
tions and to implant phakic IOLs with large optical zone
sizes. For example, one should use the Artisan 6.0 mm in
the eyes of all patients with large scotopic pupil sizes or
search for better ways to correct high myopia in these
cases, respectively.
Vitreoretinal and
Other Complications
One case of rhegmatogenous retinal detachment was
reported 3 months after the operation, but it seemed
unlikely that the problem was related to the surgery.29 It is
important to consider that most patients with implantation
of PC PIOL are high myopes and, therefore, predisposed
to spontaneous rhegmatogenous retinal detachment. For
that reason, preoperative as well as periodical retinal
examinations after phakic IOL implantation in using
mydriasis are important to detecting and treating retinal
breaks as early as possible.
To detect intraocular inflammation, laser flare photom-
etry was performed by Uusitalo et al 6 months after ICL
implantation. In this study, all eyes showed normal aque-
ous flare values.30
SUMMARY
The implantation of PC phakic IOLs seems to be a safe
method to correct high myopia and hyperopia with regard
to immediate visual and refractive results if contraindica-
tions are excluded. Thus far, there are no long-term stud-
ies that have examined PC phakic IOL implantations for
longer than 24 months. Therefore, it would be necessary
to perform such long-term examinations after several years
to prove the previous encouraging results.
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intraocular lens. J Cataract Refract Surg. 2000;26:1288-
1302.
6. Maroccos R, Vaz F, Marinho A, et al. Glare and halos after
“phakic IOL.” Surgery for the correction of high myopia.
Ophthalmologe. 2001;98:1055-1059.
7. Ardjomand N, Kolli H, Vidic B, et al. Pupillary block after
phakic anterior chamber intraocular lens implantation.
J Cataract Refract Surg. 2002;28:1080-1081.
8. Nuzzi G, Cantu C. Vitreous hemorrhage following phakic
anterior chamber intraocular lens implantation in severe
myopia. Eur J Ophthalmol. 2002;12:69-72.
9. Arevalo JF, Azar-Arevalo O. Retinal detachment in phakic
eyes with anterior chamber intraocular lenses to correct
severe myopia. Am J Ophthalmol. 1999;128:661-662.
10. Auffarth GU, Apple DJ. History of the development of
intraocular lenses. Ophthalmologe. 2001;98:1017-1028.
11. Fechner PU, van der Heijde GL, Worst JGF. Intraokulare
Linse zur Myopiekorrektion des phaken Auges. Klin
Monatsbl Augenheilkd. 1988;193:29-34.
12. Fechner PU, Strobel J, Wichmann W. Correction of myopia
by implantation of a concave Worst-iris-claw lens into pha-
kic eyes. J Refract Corneal Surg. 1991;7:286-298.
13. Menezo JL, Cisneros AL, Rodriguez-Salvador V.
Endothelial study of iris-claw phakic lens: four-year follow-
up. J Cataract Refract Surg. 1998;24:1039-1049.
14. Krumeich JH, Daniel J, Gast R. Closed-system technique
for implantation of iris supported negative power intraocu-
lar lens. J Refract Surg. 1996;12:334-340.
15. Alio JL, Mulet ME, Shalaby AM. Artisan phakic iris-claw
intraocular lens for high primary and secondary hyperopia.
J Refract Surg. 2002;18:697-707.
16. Landesz M, Worst JG, van Rij G. Long-term results of cor-
rection of high myopia with an iris-claw phakic intraocular
lens. J Refract Surg. 2000;16:310-316.
17. Gross S, Knorz MC, Liermann A, et al. Results of implanta-
tion of a Worst iris-claw lens for correction of high myopia.
Ophthalmologe. 2001;98:635-638.
18. Maloney RK, Nguyen LH, John ME. Artisan phakic intraoc-
ular lens for myopia: short-term results of a prospective,
multicenter study. Ophthalmology. 2002;109:1631-1641.
19. Perez-Santonja JJ, Bueno JL, Zato MA. Surgical correction
of high myopia in phakic eyes with Worst-Fechner myopia
intraocular lenses. J Refract Surg. 1997;13:268-281.
Complications of Phakic Intraocular Lenses 95
20. Pop M, Mansour M, Payette Y. Ultrasound biomicroscopy
of the iris-claw phakic intraocular lens for high myopia.
J Refract Surg. 1999;15:632-635.
21. Pop M, Payette Y, Mansour M. Ultrasound biomicroscopy
of the Artisan phakic intraocular lens in hyperopic eyes.
J Cataract Refract Surg. 2002;28:1799-1803.
22. Menezo JL, Avino JA, Cisneros A, et al. Iris-claw phakic
intraocular lens for high myopia. J Refract Surg. 1997;13:
545-555.
23. Perez-Santonja JJ, Iradier MT, Benitez del Castillo JM, et al.
Chronic subclinical inflammation in phakic eyes with
intraocular lenses to correct myopia. J Cataract Refract
Surg. 1996;22:183-187.
24. Perez-Torregrosa VT, Menezo JL, Harto MA, et al. Digital
system measurement of decentration of Worst-Fechner iris-
claw myopia intraocular lens. J Refract Surg. 1995;11:26-30.
25. Yoon H, Macaluso DC, Moshirfar M, et al. Traumatic dis-
location of an Ophtec Artisan phakic intraocular lens.
J Refract Surg. 2002;18:481-483.
26. Kasper T, Kohnen T. Klin Monatsbl Augenheilkd.
2003;220 (Suppl 1):S7.
27. Menezo JL, Peris-Martinez C, Cisneros A, et al. Posterior
chamber phakic intraocular lenses to correct high myopia: a
comparative study between STAAR and Adatomed models.
J Refract Surg. 2001;17:32-42.
28. Rosen E, Gore C. STAAR Collamer posterior chamber pha-
kic intraocular lens to correct myopia and hyperopia.
J Cataract Refract Surg. 1998;24:596-606.
29. Zaldivar R, Davidorf JM, Oscherow S. Posterior chamber
phakic intraocular lens for myopia of -8 to -19 diopters.
J Refract Surg. 1998;14:294-305.
30. Uusitalo RJ, Aine E, Sen NH, et al. Implantable contact lens
for high myopia. J Cataract Refract Surg. 2002;28:29-36.
31. Davidorf JM, Zaldivar R, Oscherow S. Posterior chamber
phakic intraocular lens for hyperopia of +4 to +11 diopters.
J Refract Surg. 1998;14:306-311.
32. Brauweiler PH, Wehler T, Busin M. High incidence of
cataract formation after implantation of a silicone posterior
chamber lens in phakic, highly myopic eyes. Ophthalmol-
ogy. 1999;106:1651-1655.
33. Fechner PU, Haigis W, Wichmann W. Posterior chamber
myopia lenses in phakic eyes. J Cataract Refract Surg. 1996;
22:178-182.
34. Zadok D, Chayet A. Lens opacity after neodymium:YAG
laser iridectomy for phakic intraocular lens implantation.
J Cataract Refract Surg. 1999;25:592-593.
35. Trindade F, Pereira F. Cataract formation after posterior
chamber phakic intraocular lens implantation. J Cataract
Refract Surg. 1998;24:1661-1663.
36. Sanders DR, Vukich JA, Doney K, et al. US Food and Drug
Administration clinical trial of the Implantable Contact
Lens for moderate to high myopia. Ophthalmology.
2003;110:255-266.
96 Chapter 9
37. Trindade F, Pereira F, Cronemberger S. Ultrasound biomi-
croscopic imaging of posterior chamber phakic intraocular
lens. J Refract Surg. 1998;14:497-503.
38. Jimenez-Alfaro I, Benitez del Castillo JM, Garcia-Feijoo J, et
al. Safety of posterior chamber phakic intraocular lenses for
the correction of high myopia: anterior segment changes
after posterior chamber phakic intraocular lens implanta-
tion. Ophthalmology. 2001;108:90-99.
39. Garcia-Feijoo J, Alfaro IJ, Cuina-Sardina R, et al. Ultrasound
biomicroscopy examination of posterior chamber phakic
intraocular lens position. Ophthalmology. 2003;110:163-
172.
40. Hoyos JE, Dementiev DD, Cigales M, et al. Phakic refrac-
tive lens experience in Spain. J Cataract Refract Surg.
2002;28:1939-1946.
41. Kodjikian L, Gain P, Donate D, et al. Malignant glaucoma
induced by a phakic posterior chamber intraocular lens for
myopia. J Cataract Refract Surg. 2002;28:2217-2221.
42. Fechner PU. Cataract formation with a phakic IOL.
J Cataract Refract Surg. 1999;25:461-462.
43. Trindade F, Pereira F. Exchange of a posterior chamber pha-
kic intraocular lens in a highly myopic eye. J Cataract
Refract Surg. 2000;26:773-776.
44. Baumeister M, Terzi E, Ekici Y, Kohnen T. A comparison of
manual and automated methods to determine horizontal
corneal diameter. J Cataract Refract Surg. In press.
45. Dejaco-Ruhswurm I, Scholz U, Pieh S, et al. Long-term
endothelial changes in phakic eyes with posterior chamber
intraocular lenses. J Cataract Refract Surg. 2002;28:1589-
1593.

Postoperative Care for
Phakic Intraocular Lens Implants
Vance Thompson, MD
INTRODUCTION
Until recently, refractive surgery has mainly been
focused on extraocular surgery, namely, corneal surgery.
Laser in-situ keratomileusis (LASIK) has become one of the
most commonly performed surgeries in medicine today.
With so many people with high myopia and hyperopia con-
templating vision correction surgery, it has become increas-
ingly obvious that the candidates for photorefractive kera-
tectomy (PRK) and LASIK are declining as we learn who are
good candidates and who may end up with less than quali-
ty results.1-8 Patients with higher corrections with or with-
out thin corneas have other options like phakic intraocular
lens implants (IOLs). Many of the same principles that oph-
thalmologists are comfortable with in cataract postoperative
care apply to phakic IOL postoperative care.
Phakic IOLs that are implanted today can be posterior
chamber, anterior chamber angle fixated, or anterior
chamber iris-claw.9-14 There are some features of postop-
erative care that are unique to the style of phakic IOL that
is being implanted, and these will be brought up when
appropriate in this discussion.
THE IMMEDIATE
POSTOPERATIVE PERIOD
Postoperative care begins right after the surgery is com-
pleted, which is signified by removal of the lid speculum.
After the speculum is removed, it is important to re-examine
the pressure in the eye and make sure the pressure is some-
10 Chapter
what normal and the wound is watertight. The author will
occasionally repressurize the globe after removing the
speculum if removing it significantly lowers the intraocular
pressure (IOP) because it was causing pressure on the globe.
Sometimes this can be done without replacing the speculum
because the drape is still holding the lashes open, and some-
times the speculum needs to be reinserted to safely repres-
surize the globe. The author uses balanced salt solution
(BSS) for this maneuver.
The author performs the majority of his phakic IOLs
with peribulbar anesthesia. In those situations, he postop-
eratively administers an antibiotic drop, tapes the eyelid,
places an eye patch, and tapes a metal shield. He then
instructs the patient to remove the shield 5 hours postop-
eratively and begin topical drop therapy. In the case of
topical anesthesia surgery, he administers an antibiotic
drop and tapes on a clear shield. The patient is instructed
to use topical antibiotic drops six times per day for the first
3 days and then go to four times a day unless instructed
otherwise. A topical steroid drop is prescribed four times
per day. The patient is instructed to wear the shield,
except when putting in drops, until he or she sees the
author the next morning. After that, the shield is used only
when sleeping for the first 2 weeks.
In the immediate postoperative period, if the patient
has had peri- or retrobulbar anesthesia, he or she is warned
that when he or she removes the shield, patch, and tape,
he or she will still see blurred because the anesthesia also
anesthetizes the optic nerve. They may even have some
double vision if the extraocular muscle anesthesia has not
worn off.
100 Chapter 10
Figure 10-1. A sutured wound after Artisan IOL implantation.
THE FIRST POSTOPERATIVE VISIT
The first postoperative visit involves removing the
shield and cleaning any debris on the eyelids. The author
instructs the patient on keeping his or her eyelid margins
clean. The author likes to follow the cleaning of the eye-
lids with a drop or two of topical antibiotic.
It is important to tell the patient that blurry vision is not
unusual. The author tells them that he will do a good exam
and make sure everything is just fine but not to worry
about blur. The author has also told patients preoperative-
ly that not everyone gets their final vision with one phakic
IOL surgery and that they may need a laser enhancement
or an astigmatic keratotomy postoperatively. With this
candid preoperative discussion, they are not so worried if
they have some blur the first postoperative day.
A brief history is first taken as far as what his or her com-
fort level and vision is. The uncorrected vision is checked
with and without pinhole by the staff. If the vision is rea-
sonable (ie, 20/60 or better), the staff will also check the
IOP with a Tonopen (Medtronic, Jacksonville, Fla) after
instillation of fresh topical anesthesia drops. These results
are documented in the record and then the author sees the
patient. If the IOP is elevated, it could be retained vis-
coelastic, malignant glaucoma, or pupillary block glauco-
ma. These must all be kept in mind when treating a post-
operative IOP rise.
The author is positive and upbeat with the patient no
matter what his or her mood is. He also wants to remain
very patient if he or she is at all frustrated that his or her
vision is not where he or she is hoping it would be. The
author knows that the patient will feel better after a thor-
ough exam and explanation. If the vision is not good, the
author likes to do a refraction (if there is not much corneal
edema) to see if the reduced vision is correctable with
lenses. If the patient has blurry uncorrected vision, this
Figure 10-2. A sutureless wound after STAAR ICL place-
ment.
step (ie, the refraction) can be very comforting to him or
her. In actuality, phakic IOL surgery is typically more
atraumatic than cataract surgery and there should be min-
imal corneal edema. Thus, these patients will often have
day 1 postoperative vision that has them quite excited
about this whole process. Phakic IOL surgery is one of the
most gratifying surgeries the author performs.
The author first reviews the vision and IOP measure-
ments and then does a slit lamp exam. Just prior to the slit
lamp exam, he looks at the patient’s external orbit to assess
for any redness or swelling that could imply an allergic
reaction to the povidone-iodine prep or to the tape used
on the shield. The author looks at the corneal wound with
the slit lamp and makes sure it is watertight. If it is an
Artisan lens (Ophtec BV, Groningen, Netherlands), there
are typically sutures that are assessed for tension also
(Figure 10-1). In the case of a foldable phakic IOL, such as
the Implantable Contact Lens (ICL) (STAAR Surgical AG,
Nidau, Switzerland), these lenses can often be placed in a
sutureless fashion and thus assessing for water tightness is
the main portion of the wound exam (Figure 10-2). After
assessing the wound, the author looks at the cornea, start-
ing from the surface and going in a posterior direction.
The epithelium is examined and then the stroma. If there
is corneal edema, it is graded on a I to IV scale. Descemet’s
membrane is then evaluated to make sure it is not detached
due to a complication during surgery. The endothelium is
examined to see if there was any endothelial touch during
surgery.
After assessing the cornea, examine the anterior cham-
ber for depth and cellular reaction. Because all phakic IOLs
can cause pupillary block, it is important to check at the
first day postoperative visit that this has not happened by
 Postoperative Care for Phakic Intraocular Lens Implants
Figure 10-3. Two patent PIs are very important with any phakic
IOL. Mild pupillary ovalization can be seen early in the postop-
erative period of the Artisan phakic IOL due to extreme miosis
from the carbachol.
Figure 10-5. Slit lamp exam of the distance between the posteri-
or surface of the STAAR ICL implant to the anterior surface of the
crystalline lens. Note the appropriate distance between the two.
checking the IOP and performing a quality slit lamp exam.
A pressure elevation can occur after phakic IOL implanta-
tion from retained viscoelastic or pupillary block can occur
from a nonpatent peripheral iridectomy (PI). If the IOP
elevation is high enough and prolonged enough, an aton-
ic pupil can occur, with resultant iris stromal atrophy and
permanently dilated pupil.12,15,16 Assessing the PI with
retroillumination is important because the surgeon has to
make sure it is patent (Figure 10-3). A laser PI is typically
smaller than a surgical PI and assessing patency can be
more challenging. Nevertheless, it is very important that
the red reflex be seen through the laser PI upon retroillu-
mination. If it cannot be documented that the PI is patent,
it is suggested that either the PI is made larger or a laser PI
is created in a different location. Some surgeons will rou-
101
Figure 10-4. The STAAR
ICL is vaulted to reduce
contact between the
natural lens and the
IOL.
Figure 10-6. Scheimpflug photo of the STAAR ICL verifies vault
of the IOL over the natural lens.
tinely place two PIs at separate quadrants in the superior
iris to further minimize the risk of a nonpatent PI, creating
an angle closure glaucoma attack.
After assessing depth and patency of the PI, assess and
document the cellular (flare and cell) reaction. There is typ-
ically not much inflammation with phakic IOLs as com-
pared to cataract surgery. The author does like to focus fur-
ther back and make sure there is no vitreous reaction.
In the case of the Artisan lens, the author likes to assess
the distance from the anterior surface of the implant to the
posterior cornea. He also likes to assess the distance
between the posterior surface of the IOL to the anterior
surface of the crystalline lens. If the lens is a posterior
chamber IOL, such as the STAAR ICL, it is beneficial to
examine the distance between the implant and the crys-
talline lens (Figures 10-4, 10-5, and 10-6).
At this point, the centration of the implant is docu-
mented (Figure 10-7). The pupil center can shift based on
the IOP. Therefore, if the pressure is very low after sur-
gery, the IOL may not be as nicely centered as thought at
the end of surgery. This is why intraoperatively the author
likes to make sure he has normalized the IOP before mak-
ing his final assessment on implant centration.
It may be noted at the first day postoperatively that
with the Artisan lens the pupil is not totally round in all
cases. This is particularly true if the pupil is still constrict-
ed from the miotic used intraoperatively and the postop-
erative inflammation. This is not unusual and is typically
102 Chapter 10
Figure 10-7. A well-centered Artisan lens.
from the fact that the iris is being held (ie, “enclavated”) by
the haptics of the Artisan lens. Hence, in the meridian of
the enclavation, the pupil cannot constrict as much as the
rest of the pupil (Figure 10-8). When the pupil is physio-
logic in size, it should look normal in shape unless too
much iris tissue was enclavated.
It is also important with a foldable IOL to document
that there are no tears in the implant since this can occur
during placement into the eye from the folder. Making
sure there is no foreign material that was inadvertently
placed into the eye during surgery is also important at the
slit lamp.
The author then likes to finish the slit lamp exam by
looking at the crystalline lens to make sure it is nice and
clear with no evidence of trauma. If there was lenticular
touch during surgery, a localized opacity in the anterior
lens can occur. These are typically localized and nonpro-
gressive and are more common in a posterior chamber
phakic IOL. Nevertheless, any new lens opacity needs to
be followed to assess whether or not it will be progressive.
After a complete slit lamp exam, the results are com-
municated to the patient and the postoperative instruc-
tions are then reviewed to make sure the patient is follow-
ing them well.
THE 1 WEEK POSTOPERATIVE VISIT
If everything looks routine at the first postoperative
visit, the author will see the patient at 1 week postopera-
tively with instructions to call if anything seems unusual
(eg, pain, redness, or decreased vision) so that he can see
them immediately. The main worry is the development of
any endophthalmitis in the first week. If this does occur,
there should not be a delay in diagnosis or treatment.
At the 1 week visit the author takes a history to see how
the vision is doing and how comfortable the eye feels. He
Figure 10-8. The iris is being held (ie, “enclavated”) by the hap-
tics of the Artisan lens and in the meridian of the enclavation;
therefore, the pupil cannot constrict as much as the rest of the
pupil, which can cause pupil irregularity with constriction. An
oval shape to the pupil is typically not noticed at physiologic
pupil size unless too much iris tissue was enclavated.
also reviews the medication schedule and makes sure the
patient is wearing his or her shield when he or she sleeps.
The author also rechecks the vision and performs a mani-
fest refraction. It is of note that it is not unusual for the
best-corrected visual acuity (BCVA) to actually improve
after phakic IOL placement. This is felt to be, at least in
part, due to image magnification.14
In general, everything that was performed at the slit
lamp at 1 day postoperatively is repeated 1 week postop-
eratively. The IOP is checked again to make sure there is
not an early steroid response. It is expected that any cellu-
lar response that was noted at the 1 day visit is less at this
visit. If there is an increase in anterior chamber reaction
and the vitreous is quiet with no other signs of infection,
the steroid drops are increased in frequency and consider-
ation is given to putting the patient on a stronger steroid
drop.
If there is anything unusual detected at the 1 week visit,
a repeat visit is scheduled in the next days to weeks to
make sure it is not progressive. Otherwise, if the exam is
routine at this visit, the patient is instructed to use the
antibiotic drops until he or she is 10 days postoperative
and to use the steroid drops in a gradual taper for 2 weeks.
It is worth noting that if the patient is blurry at this visit
and is having a hard time driving or working, a temporary
lens prescription can be provided to help them function.
THE 1 MONTH POSTOPERATIVE VISIT
It is at this visit that the patient is typically off all drops
and a quality assessment can be done as to the final out-
come of the procedure. If the IOL was an Artisan lens,
 Postoperative Care for Phakic Intraocular Lens Implants
sutures were placed, and there is residual cylinder, selec-
tive suture removal can begin if the positive cylinder is in
the axis of the sutures. The author typically waits 2 weeks
to see the full effect of the suture removal before consid-
ering whether or not to remove another.
If corneal edema is persistent at this visit, one needs to
consider the health of the corneal endothelium. If IOP is
normal, there is no persistent inflammation, and there is
still corneal edema, an endothelial cell count is indicated
to assess number and morphology of the endothelial cells.
With modern day surgical technique and quality phakic
IOLs, this should be a rare occurrence.
If any lens opacities were noted at previous visits, they
should be followed closely to assess whether or not they
are progressive.17 The Lens Opacity Classification System
(LOCS) III can be useful in following early lens opacities
and for documentation.18 In the STAAR ICL United
States clinical trials, a change in LOCS III score of more
than one unit from baseline was felt to be indicative of sig-
nificant lens change.19
After the refractive error is stable, one can consider
whether or not an enhancement is indicated.
WHEN TO ENHANCE
If a patient has significant cylinder preoperatively, an
astigmatic keratotomy (AK) can be performed preopera-
tively, intraoperatively, or postoperatively. AK is very
effective in lessening astigmatism before or after phakic
IOL placement. One can also place the incision at the time
of lens implantation in the steep axis of the cylinder to
lessen the astigmatism somewhat.
When to perform an astigmatic keratotomy procedure
is dependent on the approach taken for the IOL place-
ment. If it is an Artisan lens and a 6.0-mm incision is used
with the wound sutured, the author suggests waiting until
3 months after suture removal. This is done with a few vis-
its in a row separated by at least a few weeks to document
that the refractive cylinder is not changing. If it is a small-
incision, sutureless procedure, such as with the STAAR
ICL or other foldable phakic IOL, then 3 months postop-
eratively is a reasonable time to consider AK. Again,
refractive stability should be documented.
If one chooses to perform a spherical (with or without
cylinder) laser enhancement with PRK or LASIK, one
should wait a bit longer after the phakic IOL procedure.
The author suggests waiting at least 6 months to perform
PRK and 1 year to perform LASIK after an Artisan proce-
dure. He would also suggest waiting 3 months for PRK and
6 months for a LASIK enhancement after a small incision
sutureless procedure.
One also needs to keep in mind that certain tracking
devices, such as the tracker on the LADARVision laser
103
(Alcon, Fort Worth, Tex) track the pupil edge and can be
affected by the reflections of an implant. If this laser can-
not track, then the laser enhancement cannot be per-
formed.
LONG-TERM CONSIDERATIONS
As studies continue to be conducted on the long-term
risks of phakic IOLs, there appears to be good predictabil-
ity with a low risk of major complications.13,20,21 As with
any intraocular surgery, the long-term effects on the reti-
na are important to consider. Myopes are already at an
increased risk of developing retinal detachment when
compared to the general population. Myopes are at an
even greater risk of retinal detachment after intraocular
surgery when compared to postoperative nonmyopic indi-
viduals.
CONCLUSION
Phakic IOLs have made tremendous progress over the
past 20 years in terms of safety and efficacy. With proper
attention to details, including postoperative care, the risk-
to-benefit ratio becomes very acceptable for the individual
desiring refractive surgery. By following the above princi-
ples for phakic IOL postoperative care, and with the sur-
geon’s experience with the postoperative care of the
cataract patient, these patients should do quite well in the
long run. Phakic IOL surgery is coming of age, becoming
a mainstream option for patients seeking quality surgical
vision correction.
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minus optic (Worst iris-claw) lenses into the anterior cham-
ber of phakic eyes. Eur J Implant Refract Surg. 1993;5:55.
17. Fink AM, Gore C, Rosen E. Cataract development after
implantation of the STAAR Collamer posterior chamber
phakic lens. J Cataract Refract Surg. 1999;25:278-282.
18. Chylack LT Jr, Wolfe JK, Singer DM, et al. The Lens
Opacities Classification System III. The Longitudinal Study
of Cataract Study Group. Arch Ophthalmol. 1993;111:831-
836.
19. Sanders DR, Vukich JA, Doney K, Gaston M, Implantable
Contact Lens in Treatment of Myopia Study Group. U.S.
food and drug administration clinical trial of the
implantable contact lens for moderate to high myopia.
Ophthalmology. 2003;110:255-266.
20. Fyodorov SN, Zuev VK, Tumanyan ER, et al. Analysis of
long-term clinical and functional results of intraocular cor-
rection of high myopia. Ophthalmosurgery. 1990;2:3-6.
21. Menezo JL, Cisneros A, Hueso JR, et al. Long-term results
of the surgical treatment of high myopia with Worst-
Fechner intraocular lenses. J Cataract Refract Surg.
1995;21:93-98.

Comparison of Refractive Outcomes
and Complications Among
Current Phakic Intraocular Lenses
Anthony J. Lombardo, MD, PhD
INTRODUCTION
Phakic intraocular lenses (IOLs) are refractive devices
used primarily for the elective correction of higher levels
of ametropia. Because phakic IOLs are generally used in an
elective capacity and in a setting where the patient may
have several surgical as well as nonsurgical options, a clear
understanding of the results is imperative. With a com-
plete understanding of the known outcomes, including
risks and benefits, the patient and surgeon can make an
informed decision concerning phakic IOLs and with
regard to other refractive options.
Implanting an anterior chamber IOL in a phakic eye to
correct high myopia was developed and then abandoned
by Strampelli1 and Barraquer2 in the 1950s. Interest has
recently been revived by Fechner, van der Heijde, and
Worst,3 who used an iris-fixated lens, and by Joly, Baïkoff,
and Bonnet,4 who used an angle-supported lens whose
style resembled the Kelman-style multiflex anterior cham-
ber lens. Many phakic IOL designs have emerged since
1983. Today, the designs can be classified according to
the way that they are fixated in the eye: anterior chamber
angle, iris, and posterior chamber.
The general comparison of the major phakic IOLs are
outlined by virtue of several tables presented in this chap-
ter. It is exceedingly difficult to draw a fair, direct, and
accurate comparison between different designs of phakic
IOLs. Frequent design revisions mean that a particular lens
model is not implanted in any great numbers or for any
great length of time, as newer revisions of the lens are
introduced that correct the weaknesses of the preceding
11 Chapter
generation of lenses. In fact, in many of the reviewed
papers, several versions of the same lens are grouped for a
collective analysis of the refractive outcomes and compli-
cations, with some papers making no mention whatsoever
of the version of the lens implanted. None of the papers
directly compare any two lenses currently in production.
No lens is currently approved for use by the US Food and
Drug Administration (FDA).
MAJOR PHAKIC
INTRAOCULAR LENSES
Posterior Chamber
The Implantable Contact Lens
The Implantable Contact Lens (ICL) is a posterior
chamber lens based on the original design introduced by
Fyodorov5 and developed by STAAR Surgical AG (Nidau,
Switzerland).6 The first ICLs made by STAAR Surgical
were implanted in human eyes in Europe in 1993,6,7 and
more than six distinct lens designs have been manufac-
tured and implanted during clinical studies.6,8,9
The lens has a single-piece plate haptic design and is
made of a porcine collagen/hydroxymethacrylate copoly-
mer (34% water and <0.1% collagen). The optic of the lens
is 5.5 mm in diameter and is manufactured in an anterior
concave/posterior concave design for correcting myopia
and an anterior convex/posterior concave design for cor-
recting hyperopia. The central optic thickness of the
108 Chapter 11
myopic model is only 60 µm, and the optical zone varies
between 4.5 and 5.5 mm, depending on the strength of the
lens. The latest, and currently only produced, model to
correct myopia is the ICM V4 (STAAR Surgical, Monrovia,
Calif). This new ICL model was recently introduced to
increase the gap between the ICL and the crystalline lens
and is presumed to offer better vaulting over the crystalline
lens than the previous model (ie, ICM V3). This vaulting is
obtained by decreasing the radius of curvature of the pos-
terior face of the ICL. Implantation of this lens began in
November 1998. The current model to correct hyperopia is
the ICM V3 (STAAR Surgical, Monrovia, Calif).
The foldable lens may be implanted through a clear
corneal incision as small as 2.8 mm and under topical anes-
thesia. Under the protection of viscoelastic, the lens initial-
ly unfolds in the anterior chamber with the haptics residing
in the anterior chamber angle. With the aid of a widely
dilated pupil and simple specialized instruments, each foot-
plate of the plate haptic is tucked into the posterior cham-
ber. Atraumatic surgical technique places the lens in the cil-
iary sulcus without touching the native, crystalline lens. The
myopic lens is manufactured in powers of -3 to -20 D, and
the -20 D lens corrects about 15 D of myopia. The hyper-
opic lens powers range from +1.5 to +20 D, with the +20 D
lens correcting about +12 D at the spectacle plane.
Success with the lens depends in large part on the vault-
ing of the phakic IOL over the crystalline lens. Ideally, the
vaulting of the lens is about 100% of corneal thickness, or
approximately 500 µm. This vaulting is governed by the
length of the phakic IOL and the sulcus-to-sulcus distance.
Currently, no good method exists to accurately measure
the sulcus diameter; therefore, adjusted white-to-white
measurements are used as a surrogate. The lens is manu-
factured in total lengths ranging from 11 to 13 mm.
Choosing a lens that is too short for the required sulcus-
to-sulcus span can result in a decreased or absent vault
over the crystalline lens. Subsequent cataract formation
can result from either chronic intermittent touch to the
anterior capsule or blocking of aqueous flow that bathes
the anterior aspect of the crystalline lens.10,11 Choosing a
lens that is too long for the eye can result in chronic iris
chafing and attendant pigment liberation with possible
pigmentary glaucoma. A lens that is too long for the eye
can also vault the phakic lens into the pupil, increasing the
risk of pupillary block glaucoma or angle crowding. All
phakic IOL manufacturers recommend either an iridecto-
my or an iridotomy to prevent pupillary block glaucoma.
Clinicians, anticipating that all the aqueous will flow
through the defects, have learned to place two large iris
defects. Placing them 90 degrees apart guards against one
of them being occluded by the lens haptic should the lens
rotate.
US FDA clinical evaluations started in 1997, and the
myopic and hyperopic ICL models are currently in Phase
III FDA trials.9 A toric ICL is also under US FDA clinical
trials.
The Phakic Refractive Lens
The Phakic Refractive Lens (PRL), manufactured by
Medennium, Inc (Irvine, Calif) and distributed by CIBA
Vision (Duluth, Ga), has been in development since 1987.
The PRL has a single-piece plate design and is made of sil-
icone. Like the ICL, the PRL is designed for implantation
in the posterior chamber for the correction of myopia and
hyperopia. Its distinction is that it is designed to float on
the crystalline lens; there are no feet to its plate haptics.
The myopic PRL model 101 is 11.3 mm long with an
optical zone that varies from 4.5 to 5.0 mm according to
the lens’ dioptric power. The hyperopic PRL model 200
has an overall length of 10.6 mm with an optical zone of
4.5 mm. Hyperopic and myopic models are 6 mm wide.
The thickness of the PRL optic is dependent on the diop-
tric power, with a maximum of 0.6 mm. The myopic lens
is manufactured in powers ranging from -3 to -20 D and
corrects up to -23 D. The hyperopic model is made from
+3 to +15 D and corrects a maximum of +11 D. An older
myopic model (PRL 100) with a 10.8 mm length used in
some of the studies is not available today.
The PRL is introduced into the posterior chamber
through a 3.0- to 3.5-mm clear corneal incision and stabi-
lized between the iris and the crystalline lens without con-
tacting the anterior capsule.
The lens has secured Europe’s Conformité Européenne
(CE) mark, and US FDA Phase III clinical investigations
are ongoing.
Iris-Fixated
The Artisan Lens
The original iris-claw lens was developed by Worst and
was designed to be used for the correction of secondary
aphakia after cataract surgery. The lens has been implant-
ed in approximately 300,000 aphakic eyes worldwide after
being introduced in 1978. However, these early iris-fixat-
ed lenses had a propensity to form synechiae to the mobile
aphakic pupillary margin and, thus, carried an increased
risk of cystoid macular edema and corneal decompensa-
tion.12 By 1986, Worst and Fechner modified the existing
iris-claw lens into a negative-powered biconcave lens to be
used in highly myopic phakic eyes.3,13 At that time, this
new Worst-Fechner claw lens had an optic diameter of
4.5 mm, and a few hundred of these lenses were implant-
ed with good refractive results.3,13-16 In 1991, the design
of the optic was altered to an anterior convex/posterior
concave shape to increase safety, and the diameter of the
optic was increased to 5 mm to reduce halos and glare.
This new lens, called the Worst myopia claw lens, has
been implanted ever since.17,18 In 1997, an additional
 Comparison of Refractive Outcomes and Complications Among Current Phakic IOLs 109

model with a 6-mm optic diameter was added to address Anterior Chamber
potential glare and halos in patients with large pupils. In
1998, the name of the lens was changed to the Artisan The NuVita MA20
myopia lens. There was, however, no change in lens
There are two major anterior chamber lenses in produc-
design; it still has an anterior convex/posterior concave
tion that have published outcomes—the NuVita MA20
optic.
(Bausch & Lomb Surgical/Chiron Vision, Rochester, NY)
The current Artisan design is a one-piece IOL manufac-
and the ZSAL-4 (Morcher GmbH, Stuttgart, Germany).
tured of polymethylmethacrylate (PMMA) with an ultravi-
In 1987, Baïkoff and Joly4,20,21 modified the Kelman
olet-blocking material. The lens is marketed by Ophtec
Multiflex IOL used in cataract surgery into a negative
USA Inc (Boca Raton, Fla). The total length of the Artisan
biconcave lens for the correction of high myopia. This
lens is 8.5 mm. The optic vaults approximately 0.87 mm
first generation IOL, called the Baïkoff ZB lens, was asso-
anterior to the iris, allowing clearance from both the ante-
ciated with an unacceptably high incidence of endothelial
rior lens capsule and the corneal endothelium. Current
cell loss and with marked changes in endothelial cell mor-
Artisan lenses are models 206, which has a 5-mm optic and
phology.12,22,23 These changes were probably caused by
is available in powers -3 to -23.5 D, and model 204, which
excessive contact between the edge of the IOL optic and
has a 6-mm optic and is available in powers
adjacent corneal endothelium; a separation of only 0.71 to
-3 to -15.5 D. The hyperopic model 203, with a 5-mm
1.50 mm in one study.12 Because of these endothelial
optic, is manufactured in powers +1 to +12 D. A hyperop-
problems, Baïkoff modified the design to reduce the IOL’s
ic model with a larger diameter optic is under development.
proximity to the cornea. The subsequent design, the ZB
The new Artisan Toric model was designed to correct
5M lens, gained approximately 0.5 mm in IOL-cornea
spherical and cylindrical errors simultaneously. So that
spacing in comparison with the first model.12,24,25 The ZB
surgeons can implant the Toric model in the horizontal
5M model was used from 1990 through 1997. Numerous
position to which they are accustomed, two models are
subsequent clinical studies26-28 demonstrated reasonable
available. In model A, the toric axis runs parallel to the
optical results and less long-term endothelial cell loss with
claws for correction of with-the-rule astigmatism. In model
this lens. Continued pupillary ovalization (22.6%), glare
B, the toric axis runs perpendicular to the claws for cor-
complaints (12.5%), and pupillary block (3.8%) prompted
rection of against-the-rule astigmatism. Available powers
the next generation of lenses.26
can correct -3 to -20.5 D of myopia or from +2.0 to +12.0
To further reduce the complications, modifications
D of hyperopia along with 2.0 to 7.5 D of astigmatism
were made to create the NuVita MA20. This phakic IOL
(power increments are 0.5 D). The Artisan Toric phakic
employs a 5-mm optic with a treated posterior edge and a
IOL measures 8.5 mm in overall length and features a
4.5-mm optical zone to address refracted glare. The optic
5-mm anterior convex/posterior concave optic.
has an anterior convex/posterior concave design. The hap-
Generally, a corneal, limbal, or scleral incision is fash-
tics loops have been redesigned to reduce pressure in the
ioned under retrobulbar anesthesia. Under the protection
angle that may lead to pupil ovalization. Vaulting has been
of viscoelastic and a pharmacologically constricted pupil,
changed from a step vault to a straight continuous angula-
a portion of midperipheral iris is drawn into the diametri-
tion to further minimize potential contact between the
cally-opposed claws of the phakic IOL in a process called
footplate and the iris, and haptic footplates better conform
enclavation. Enclavation is an ambidextrous procedure (ie,
to iridocorneal angle geometry to disperse compression
the right haptic is enclavated with the right hand, and the
forces over a broader area.
left haptic is enclavated with the left hand) and one in
An angle-supported phakic IOL is attractive because of
which care must be taken not to damage the corneal
the ease with which it can be inserted in the anterior
endothelium, iris insertion, or lens.
chamber and fixed in the angle. Insertion of an angled-sup-
The incision needed to insert the Artisan lens is slight-
ported phakic IOL should be familiar to a surgeon experi-
ly larger than the diameter of the optic. Approximately a
enced with the insertion of an anterior chamber
5.5-mm incision for the 5-mm optic and 6.5 mm for the
pseudophakic IOL. Because of their nonfoldable PMMA
6-mm optic is required.19 Adjusting the anterior-posterior
design, insertion of the NuVita lens requires a 5.5-mm
placement of the incision as well as adjusting the tension
incision. As with the Artisan lens, placement of the inci-
on the sutures used to close the incision are means by
sion and the nature by which it is closed can reduce pre-
which preoperative astigmatism can be reduced. The
operative astigmatism or induce irregular astigmatism.
potential for increasing astigmatism or inducing irregular
NuVita IOLs were implanted in an experimental clini-
astigmatism also exists.
cal trial in 1997 and are now commercially available in
Clinical investigation of the Artisan lens began in
Europe and South America. Bausch & Lomb Surgical has
October 1997 in the United States under FDA supervision;
not yet brought this style of phakic IOL to the United
both myopic and hyperopic models are in Phase III. The
States.
Artisan lens carries Europe’s CE mark.
110 Chapter 11
The ZSAL-4
Pérez-Santonja and Zato also developed an angle-sup-
ported, single-piece PMMA, anterior chamber phakic IOL
based on the Kelman Multiflex lens.29 Their first genera-
tion lens, the ZSAL-1 phakic refractive lens, was intro-
duced in 1991. Successive generations of lenses altered the
anterior angulation of the lens as well as changed the
optic. In 1994, Pérez-Santonja and Alió developed the
fourth and current generation lens, the ZSAL-4, that was
based on the previous models.29
Morcher GmbH (Stuttgart, Germany) manufactures
and markets the ZSAL-4 as Model 93A. The diameter of
the optic is 5 mm. The optic design is anterior plano/pos-
terior concave and has a multifaceted edge designed to
reduce refracted glare. A 19-degree haptic angulation
reduces potential iris contact and allows central clearance
from the crystalline lens of approximately 1.0 mm. The
phakic IOL has long Z-shaped haptics to increase haptic
flexibility and decrease compression forces against angle
structures. The overall length of the lens is 13.0 mm, and
the lens power ranges from -6 to -22 D. A ZSAL-4/PLUS
model is available (Morcher Model 99C) with a 5.3-mm
optic and 22.7-degree haptic angulation.
The details of surgical placement of the ZSAL-4 are
similar to those of the NuVita lens. The ZSAL-4, with its
5-mm optic, will require an approximately 5.5-mm inci-
sion. The ZSAL-4 lens became available in Europe in
January 1995.
Others
The Vivarte is a foldable anterior chamber lens market-
ed by CIBA Vision (Duluth, Ga). They claim the lens’
three-point fixation in the anterior chamber increases its
stability. The lens is CE approved in Europe, and US FDA
clinical trials are ongoing.
Ophthalmic Innovations International, Inc (Ontario,
Canada) markets the Phakic 6 anterior chamber angle-sup-
ported phakic IOL. Its PMMA design resembles the design
of the ZSAL-4 lens. It is manufactured with a 6-mm optic
and is available in total lengths of 12 to 14 mm. The power
range is -2 to -25 D and +2 to +10 D. The company claims
that its heparin-surface modified phakic IOL reduces
synechiae. The lens has the European CE mark.
IOLTech (La Rochelle, France) has designed the GBR,
an anterior chamber phakic IOL with a foldable optic and
rigid three-point fixation haptics similar to the Vivarte. Its
5.5-mm optic is available in powers from -7 to -25 D. This
lens can be implanted through a 3.2-mm incision. This
lens has the European CE mark.
Although inferences can be drawn by comparing these
newer models to existing models, there is, as yet, no peer-
reviewed studies to support their efficacy and safety.
RESULTS
Phakic IOL surgery has developed significantly since
Strampelli’s initial attempt to implant a minus power ante-
rior chamber lens in myopic eyes.1 Each of the major clas-
sifications of phakic lenses has undergone significant revi-
sions, ever since Fechner’s modification of the Worst iris-
claw lens and Baïkoff’s modification of the Kelman
Multiflex anterior chamber IOL in the mid-1980s.15-
17,26,30,31 These revisions are driven by the results of the
ongoing US FDA and international clinical trials as well as
by unpublished experience. Manufacturing processes are
improving and materials are in evolution. As more of a par-
ticular model spreads to surgeons of all skill levels, spe-
cialized instruments are developed and “pearls” are shared
that allow higher rates of successful implantation. With
large groups of data, nomograms and refractive outcomes
are improved. Attention can be paid to the effect these
lenses have on qualitative vision parameters and the high-
er order aberrations their insertion induces.
Faced with this rapidly enlarging and improving arena,
a fair comparison among these lenses can be exceedingly
challenging. The development and use of improved mod-
els often occurred within the data collection period of a
single study.32-34 Except where noted and in order to pres-
ent a fair comparison, only the studies reporting results
from the latest version of each of the lenses have been
included in the review. The reader is encouraged to turn to
the original literature for details on lens model specifics
and details of the surgeries.
Refractive Outcomes
Myopic Results
The major clinical studies showing refractive outcomes
for the correction of high myopia with phakic IOLs are
detailed in Table 11-1. Each of the studies was published
in 1997 or later and is, in general, a nonrandomized con-
secutive case series. Of the 1344 eyes included in the
table, the experience with the Artisan lens represents the
largest proportion of eyes (61%). The design and implan-
tation of the Artisan lens has been unchanged since its
modification from the Worst-Fechner lens in 1991, and,
thus, the follow-up from Artisan implantation is also the
longest. For the reasons mentioned above, only studies
including the latest generation of lenses are included (ie,
the ICL MV4, the PRL 101, the Artisan 204 and 206, the
ZSAL-4, and the NuVita MA20). The ICL and Artisan
studies enrolled eyes with lower degrees of myopia than
the PRL, ZSAL-4, and NuVita. This context should be rec-
ognized when interpreting much of the refractive and out-
comes data. The lens power nomograms and the surgical
complication rates for the very high myopes are more
 Table 11-1

MAJOR CASE SERIES INVOLVING IMPLANTATION OF A PHAKIC INTRAOCULAR LENS TO CORRECT MYOPIA
Efficacy Safety
Lens Reference Eyes Mean Mean Range Mean Postop Postop UCVA UCVA Efficacy BCVA BCVA BCVA Safety
[n] Follow- Preop of Postop 0.5 D ± 1.0 D >20/20 >20/40 Index Loss of Loss of Gain of Index
Up SE Refrac- SE (D) (%) (%) (%) (%) One Line Two or Two or
(months) (D) tion (D) (%) More More
Lines Lines
(%) (%)

ICL ITM Group43 28 24 -10.05 -3.00 to -0.56 57 80 51 93 NR 7.8 1.6 11 NR

-20.00
Bloomenstein 65 24 -8.47 -3.00 to 0.31 75 92 52 92 NR 8 0 15 NR
et al42 -16.25
Arne et al40 58 6 -13.85 -8.00 to -1.22 NR 57 NR NR 0.84 5 0 40 1.46
-19.25
Uusitalo 38 13 -15.10 -7.75 to -2.00 71 82 53 53 NR 63 0 41 NR
et al44 -29.00
Gonvers 22 7 -11.5 -6.87 to -1.19 32 45 18 68 NR 0 0 NR NR
et al32a -15.50
Menezo 12 18 -16.00 -11.50 to -0.73 33 43 0 75 1.04 0 0 75 1.59
et al33b -28.00

PRL Hoyos et al45 17 12 -18.46 -11.85 to -0.22 53 82 NR NR 1.04 0 0 18 1.14

-26.00

Artisan Budo et al37 249 36 -12.95 -5.0 to -0.6 57 79 34 77 1.03 2.0 1.2 43 1.31
-20.0
Maloney 155 6 -12.69 -5.50 to -0.54 55 90 26 83 NR 9.5 0 12 NR
et al46 -22.50
Alexander 135 6 -12.66 -4.88 to -0.35 63 90 NR 83 NR 3.0 0.74 22 NR
et al19 -22.75
Menezo 94 49 -14.73 -7.00 to -0.84 49 80 13 62 1.00 0 0 82 1.52
et al34d -28.00
Landesz 78 11 -17 -6.25 to -2 50 68 30 73 1.00 6.4 2.6 28 1.21
Comparison of Refractive Outcomes and Complications Among Current Phakic IOLs

et al31 -28.00
(continued)
111
 112
Chapter 11

Table 11-1 (Continued)

Efficacy Safety
Lens Reference Eyes Mean Mean Range Mean Postop Postop UCVA UCVA Efficacy BCVA BCVA BCVA Safety
[n] Follow- Preop of Postop ± 0.5 D ± 1.0 D >20/20 >20/40 Index Loss of Loss of Gain of Index
Up SE Refrac- SE (D) (%) (%) (%) (%) One Line Two or Two or
(months) (D) tion (D) (%) More More
Lines Lines
(%) (%)

Artisan Dick et al36e 45 6 -8.90 -1.25 to -0.50 83 100 6.3 85 1.03 0 0 33 1.25
-21.25
Malecaze48 25 12 -10.19 -8.00 to -0.95 24 60 NR 60 0.71 12 0 24 1.12
-12.00

ZSAL-4 Pérez-Santonja 23 24 -19.56 -16.75 to -0.65 56 83 0 61 1.12 NR 0 NR 1.45

et al29 -23.25

NuVita Allemann 20 24 -18.95 -14.75 to -1.93 10 10 <5 NR 0.68 0 0 65 1.67

et al35 -22.75

SE = spherical equivalent, UCVA = uncorrected visual acuity, BCVA = best-corrected visual acuity, NR = not recorded
aICM V3 and V4
bICM V2 to V4
cConcurrent limbal relaxing incisions to reduce corneal astigmatism
dWorst-Fechner and Worst
eToric model
 Comparison of Refractive Outcomes and Complications Among Current Phakic IOLs
problematic than with the moderate and high myopes.
The studies with the ICL and Artisan lenses have
approached the lower myopes—as low as -3 D with the
ICL and -4.88 D with the Artisan. This may be because the
increased experience clinicians have gained with these two
lenses allows them to feel more confident with the low
myope.
Regarding the predictability and visual acuity results,
every effort was made to adjust or eliminate the appropri-
ate data when residual myopia for enhanced near vision
was intended. Often the degree of myopia that these pha-
kic IOLs are able to correct is limited by the maximum
manufactured dioptric power. The data were not correct-
ed for this factor. This issue should not be overlooked
because expanding the range of these lenses to fully cor-
rect the highest myopes involves more than simply
increasing the dioptric power of the optic. Mechanical
limitations that cause the lens to rub against adjacent crys-
talline lens, iris, or endothelium are distinct concerns.
Moreover, the quality of vision and spherical aberrations
may reduce the effectiveness of these phakic IOLs at
extreme dioptric powers.
The other studies achieve good refractive outcomes
with mildly myopic endpoints. On average, 55% achieve a
postoperative refraction within 0.5 D of the attempted,
while up to 92% are within 1 D of attempted. The ICL and
Artisan lenses have impressive results, with approximately
30% to 50% achieving an uncorrected visual acuity
(UCVA) of 20/20 or better and 70% to 90% achieving a
UCVA of 20/40 of better.
At first glance, the NuVita study by Allemann et al
appears to have a poorer refractive outcome.35 The data
presented in the original manuscript, however, indicate
that the preoperative visual acuity was worse than the
other studies—no eye had a preoperative best-corrected
visual acuity (BCVA) better than 20/30, and the mean pre-
operative logarithmic BCVA was only 20/50.
The efficacy index is defined as the postoperative dec-
imal UCVA divided by the preoperative decimal BCVA.
Although not strictly mathematically correct, this index
gives an indication of the refractive outcome at a glance.
Larger indices are the desired outcome.
As a whole, this modern, latest generation of phakic
IOLs seems remarkably safe. On average, loss of one line
of visual acuity occurs in about 5%, while <1% of eyes lose
two or more lines of vision. About one-third of patients
gain two or more lines of vision. In one remarkable study
by Menezo et al, not one eye of 94 eyes implanted with
the Artisan lens lost any lines of visual acuity.34 At 3 years
after surgery, 5% showed no gain in lines of BCVA, 13%
gained one line, 23% gained two lines, 31% gained three
lines, 26% gained four lines, and 2% gained five lines. The
safety index is defined as the postoperative decimal BCVA
divided by the preoperative decimal BCVA. All indices
were greater than 1.
113
Hyperopic Results
The major studies involving the implantation of a pha-
kic IOL to correct hyperopia are detailed in Table 11-2.
The studies involve a total of 126 eyes published since
1998. Only the latest models of phakic IOL are included
(ie, the ICL HV3, the PRL 200, and the Artisan 203). No
peer-reviewed publications exist for the correction of
hyperopia with an anterior chamber angle-supported pha-
kic lens that is currently in production. Mean follow-up is
less than that for the myopic phakic IOL group. Average
preoperative spherical equivalent was +5.61 D. Rosen et al
included an eye with a refraction of just +2.25 D sphere.8
Mean postoperative refractions are well within the
0.5 D steps in which the lenses are manufactured.
Predictability is very good, and the percentage of eyes
within 0.5 D and 1 D of the targeted refraction is 70% and
93%, respectively; results that, in most cases, exceed the
myopic data. UCVAs are very good and the efficacy
indices (defined earlier) are also very good.
Correction of high hyperopia with phakic IOLs seems
to be a relatively safe procedure, with an average of 7%
losing one line of BCVA and 1.8% losing two or more
lines of BCVA. An average of 17% gained two or more
lines of BCVA. All reported safety indices were greater
than 1.
Toric Results
The only peer-reviewed publication describing the sur-
gical outcomes of a toric phakic IOL was recently pub-
lished.36 The Artisan Toric model can correct concurrent
myopia and hyperopia, and the outcomes are listed in the
appropriate tables. In the study, the average magnitude of
the refractive astigmatism was reduced from 3.7 D preop-
eratively to 0.7 D postoperatively.
Complications
As with cataract surgery, the list of potential complica-
tions with phakic IOL surgery is long. Virtually every
structure in the eye is at risk in the operative or postoper-
ative period. Retrospective and prospective studies have
identified the most common complications (Table 11-3).
Some complications, such as glare and halos, are shared
among all types of lenses, whereas other complications are
more lens-specific.
Whenever the cornea is incised—whether penetrated
or perforated—some degree of regular or irregular astig-
matism can be induced. With the self-sealing clear corneal
incisions used to place the ICL, induced astigmatism is
much less likely than with incisions as large as 6.5 mm to
implant either the Artisan lens or an angle-fixated phakic
IOL. Only a few published reports quantify the induced
regular astigmatism associated with phakic IOL implanta-
tion. In the largest series of published eyes with the Artisan
lens, Budo et al reduced the mean preoperative astigma-
 114

Table 11-2

MAJOR CASE SERIES INVOLVING IMPLANTATION OF A

Chapter 11

PHAKIC INTRAOCULAR LENS TO CORRECT HYPEROPIA

Efficacy Safety
Lens Reference Eyes Mean Mean Range Mean Postop Postop UCVA UCVA Efficacy BCVA BCVA BCVA Safety
[n] Follow- Preop of Postop ± 0.5 D ± 1.0 D >20/20 >20/40 Index Loss of Loss of Gain of Index
Up SE Refrac- SE (D) (%) (%) (%) (%) One Line Two or Two or
(months) (D) tion (D) (%) More More
Lines Lines
(%) (%)

ICL Bloomenstein 20 24 +5.55 +3.00 to +0.06 80 95 40 80 NR 25 5 10 NR

et al42 +7.75
Pesado 15 12 +7.77 +4.75 to +0.02 69 92 0 3 NR 0 77 NR NR
et al48 +11.75
Sanders et al49 10 6 +6.63 +2.50 to +0.20 80 90 70 100 NR 0 0 20 1.13
+10.88
Rosen et al8 9 3 +4.26 +2.25 to +0.26 89 89 44 89 0.98 11 0 22 1.16
+5.62

PRL Hoyos et al45 14 12 +7.77 +5.25 to -0.38 50 79 NR NR 0.60 7.1 0 0 1.00

+11.00

Artisan Alió et al51 29 14 +6.06 +3 to +9 +0.10 79 97 7 66 0.83 3.4 0 28 1.11

Dick et al36b 22 6 +3.25 0 to +6.5 -024 50 100 18 96 1.03 0 0 14 1.25

SE = spherical equivalent, UCVA = uncorrected visual acuity, BCVA = best-corrected visual acuity, NR = not recorded
aConcurrent limbal relaxing incisions to reduce corneal astigmatism
bToric model
 Table 11-3

REPORTED COMPLICATIONS IN MAJOR CASE SERIES

INVOLVING IMPLANTATION OF A PHAKIC INTRAOCULAR LENS
Lens Reference Eyes Mean- Endothelial Cell Pupil Pigment IOL Decen- Chronic Pupillary Block Cataract Glare and
(n) Follow-Up Loss Irregularity Dispersion or tration or Glaucoma Glaucoma (%) (%) Halos
(months) (%) Lens Deposits Rotation (%) (%) (%)
(%)

ICL Sanders et al41 523 17 NR 0.2 NR 1.9 0 4.0 2.9 4.1

Bloomenstein et al42 85 24 NR 0 0 0 NR 1.2 21 0
Arne et al40 58 6 -20% at 2 years 0 100 NR 3.4 NR 3.4 54
Uusitalo et al44 38 22 NR NR NR 5.3 0 7.9 7.9 NR
Dejaco- 34 >24 -12.3% at 4 years NR NR NR NR NR NR NR
Ruhswurm et al38a
Gonvers et al32b 32 7 NR NR 88 NR 62 0 12.5 NR
Menezo et al33 12 18 NR 0 42 17 0 0 25 8.3
Sanders et al49 10 6 NR 0 0 NR 0 0 0 NR
Rosen et al8 9 3 NR NR 22 NR NR 22 NR NR

PRL Hoyos et al45 31 12 NR NR 3.2 18 NR 6.4 3.2 13

Artisan Budo et al37c 249 36 -94% at 3 years 0.4 NR 8.8 NR 0.8 0.4 8.8
Maloney et al46d 155 6 +0.23% at 6 12 NR NR 0 0 2.4 2.4
months
Alexander et al19e 135 6 +0.3% at 6 1.5 0 0.74 0 0 1.5 3
months
Menezo et al39f 111 38 -13.42% at 4 0.9 NR 1.34 4.5 0 0 1.8
years
Landesz et al52 78 24 +6.1% at 2 years 0 NR NR NR 0 2.6 13
Dick et al36 70 6 -4.5% at 6 0 1.4 1.4 0 0 0 5.7
months
Pérez-Santonja et al53 30 24 -17.6% at 2 years NR NR NR NR NR NR NR
Alío et al51 29 12 -9.4% at 1 year 5.3 15.8 3.4 NR 0 NR 6.8
Malecaze et al47 25 12 -1.8% at 1 year NR NR NR 0 NR NR 5.2
Comparison of Refractive Outcomes and Complications Among Current Phakic IOLs

(continued)
115
 116
Chapter 11

Table 11-3 (Continued)

Lens Reference Eyes Mean Endothelial Cell Pupil Pigment IOL Decen- Chronic Pupillary Block Cataract Glare and
(n) Follow-Up Loss Irregularity Dispersion or tration or Glaucoma Glaucoma (%) (%) Halos
(months) (%) Lens Deposits Rotation (%) (%) (%)
(%)

ZSAL-4 Alío et al27, 263 59, 72 -9.3% at 7 years 16 NR NR 7.2 0 3.4 10

Alio et al54g, 18 24 -4.2% at 2 years 17 13 48 0 0 0 26
Pérez-Santonja29

NuVita Allemann et al35 20 24 -1.4% at 2 years 40 NR 80% with 4.8 0 0 20

with 15 degree
rotation

NR = not recorded
aICM V2 to V4 and ICH V2 to V3
bICM V3 and ICM V4
c5-mm optic only
d5- and 6-mm optic
e5- and 6-mm optic

fWorst-Fechner and Worst

gZB 5M and ZSAL-4

 Comparison of Refractive Outcomes and Complications Among Current Phakic IOLs
tism of 1.23 D to 0.84 D postoperatively.37 The induction
of irregular astigmatism would manifest itself as a decrease
in the UCVA, but especially the BCVA. Budo et al report
1.2% of the eyes in their series lost two or more lines of
BCVA. The remainder of the data in Tables 11-1 and
11-2 suggest that there are no large increases in irregular
astigmatism after implanting phakic IOLs. No study has
specifically looked at irregular astigmatism with
retinoscopy, topography, or wavefront aberrometry.
Even the gentlest of anterior segment surgeries results
in an immediate postoperative loss in endothelial cell num-
bers, leading to a decrease in the density of the cells. An
immediate decrease in central endothelial cell densities has
been recorded after the insertion of all types of phakic
IOLs. Although the immediate effect on the endothelial
cell density is not as great as it is with phacoemulsification,
the concern in this patient population (with a mean age
much younger than those undergoing phacoemulsifica-
tion) really should be the long-term endothelial loss initi-
ated by the insertion of a phakic IOL. The chronic loss of
endothelial cells is mediated by chronic or intermittent
touch of the phakic IOL to the posterior cornea or can be
the endpoint of chronic, low grade iridocyclitis induced
by the phakic IOL. By recording serial measurements on
the same patients and by examining the morphologic fea-
tures of the endothelial cells, investigators have concluded
that the bulk of the endothelial loss happens initially, with
minimal loss thereafter. The studies with the longest fol-
low-up of each of the lenses show a 12% loss at 4 years
with the ICL,38 a 13% loss at 4 years with the Artisan,39
and a 9% loss at 7 years with the ZSAL-4.27
Pupil irregularity is a complication of principally the
anterior chamber phakic IOLs. With the current generation
of anterior chamber phakic IOLs, pupil ovalization rates of
16% to 40% can be expected. These are progressive and
probably related to chronic irritation of the phakic IOL
footplates in the anterior chamber angle. Better sizing of
the lenses and redesigned haptics that spread the force
more evenly in the angle will be features of the next gener-
ation of phakic IOLs. A small percentage of eyes with the
Artisan lens will show a nonprogressive irregular pupil
related to improper iris enclavation. In one large study, 4%
reported minor surgical difficulties inserting the lens.19
Pigment dispersion or deposits on the phakic IOL can
be associated with pigmentary glaucoma. This complica-
tion seems to be related to the level of contact between the
phakic IOL and the uvea. Arne et al40 reports pigment
deposits on the periphery of the ICL optic in 100% of this
series of 58 ICLs. In two of the eyes (3.4%), increased
intraocular pressure necessitated the chronic use of topical
beta blockers. Pigment dispersion has been reported in the
117
iris-fixated and angle-fixated models, but to a lesser
degree.
IOL decentration is reported at a low incidence with
the self-centering design of the ICL. Decentration with
the Artisan is dependent on the skill of the surgeon to
enclavate the lens in the proper position. Improper
enclavation is a complication that can lead to an irregular
pupil, phakic IOL decentration, and glare. In the hands of
the clinicians currently using the lens, decentration is
reported at a rate of 1% to 13%.
Pupillary block glaucoma seems to be a feature primari-
ly of the posterior chamber lenses. This complication is
reducing in incidence as clinicians learn to make two large
iridotomies or iridectomies prior to implantation of the
lens. If the iris defects are made 90 degrees apart, both
cannot be blocked simultaneously should the lens rotate.
This is particularly important with the PRL.
The occurrence of any lens opacity—whether visually
significant or not—is listed in Table 11-3. The risk of
cataract is highest with the posterior chamber lenses. In a
comprehensive retrospective review of the two latest
myopic models of the ICL, Sanders et al demonstrate a
marked reduction in the incidence of cataract with the
newest generation of ICLs that have the increased vaulting
over the crystalline lens (ICM-V4).41 Their data come
from eyes enrolled in the US FDA clinical trial for myopia.
The publication notes 15 anterior subcapsular opacities
greater than “trace” density in 523 eyes receiving the ICL-
V4 model. Of these 15, six were associated with the ICL
being removed and reinserted at surgery. Four cataracts
were deemed “clinically significant.” Bloomenstein et al,
who implanted only the ICL-V4 model, noted that 18 of
86 eyes (21%) in their study had “asymptomatic anterior
subcapsular changes.”42 They note that the changes are
nonprogressive and “appear more like a scratch on the sur-
face of the anterior capsule.” The Artisan lens also carries
a risk of anterior subcapsular cataracts as well as anterior
nuclear vacuoles associated with the trauma of insertion.
The presence of glare and halos is a feature primarily of
the Artisan and angle-fixated lenses. The Artisan is manu-
factured in models with optics of 5 and 6 mm in diameter.
In every study that has examined the association, more
subjective complaints are associated with the 5-mm optic
model than the 6-mm optic model. The 6-mm lens is not
made above -15.5 D because the optic thickness at that
dioptric power would place the lens edge too close to the
corneal endothelium. The anterior location of the angle-
fixated lenses necessitates a smaller optic, and this is
thought to be the cause of the glare complaints. The
ZSAL-4 and NuVita lenses have optic edge modifications
in an attempt to control this symptom.
118 Chapter 11
CONCLUSIONS
In general, the results are encouraging. The group of
patients approached with phakic IOLs are challenging,
indeed, with myopia up to -29 D and hyperopia up to +18
D. Refractive outcomes are very good with a high propor-
tion of patients within 1 D of their intended target and
with a UCVA of 20/40 or better. The efficacy ratios
approach 1.00 in the hyperopic cases and often exceed it
with the myopic cases. As surgeons continue to gain expe-
rience with these lenses, surgical nomograms will get more
accurate, and the variables that control refractive out-
comes will become clearer. Phakic IOL surgery is also rea-
sonably safe. In this challenging set of eyes with high
refractive errors, the vast majority of patients do very well
with a significant portion gaining lines of BCVA. Safety
indices in all reviewed studies were greater than 1.00.
Every new technique, new instrumentation, or new
technology needs the accumulation of postoperative data
over time to reveal potential faults. Phakic IOL technolo-
gy seems to be a perfect example of this concept. None of
the lenses are perfect, but each has improved markedly
over the past 15 years as dictated by the results of large
clinical studies. As these lenses gain US FDA approval and
more lenses gain the European CE mark, choosing a lens
may depend more on surgeon preference and lens avail-
ability than solid evidence that one phakic IOL is the best.
Successive generations of lens will continue to improve on
the efficacy and safety of the current generation. Time is
required to evaluate the risk, and these lenses should be
used with caution.
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19. Alexander L, John M, Cobb L, et al. U.S. clinical evaluation
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interim phase 3. Optometry. 2000;71:630-642.
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24. Baïkoff G. The refractive IOL in a phakic eye. Ophthalmic
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27. Alió JL, de la Hoz F, Pérez-Santonja JJ, et al. Phakic anteri-
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28. Baïkoff G, Joly P. Correction chirurgicale de la myopie forte
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29. Pérez-Santonja JJ, Alió JL, Jiménez-Alfaro I, Zato MA.
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30. Praeger DL, Momose A, Muroff LL. Thirty-six month fol-
low-up of a contemporary phakic intraocular lens for the
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31. Landesz M, Worst JGF, van Rij G. Long-term results of cor-
rection of high myopia with an iris-claw phakic intraocular
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32. Gonvers M, Othenin-Girad P, Bornet C. Implantable con-
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33. Menezo JL, Peris-Martinez C, Cisneros A, et al. Posterior
chamber phakic intraocular lenses to correct high myopia: a
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34. Menezo JL, Aviño JA, Cisneros A, et al. iris-claw phakic
intraocular lens for high myopia. J Refract Surg. 1997;13:
545-555.
35. Allemann N, Chamon W, Tanaka HM, et al. Myopic angle-
supported intraocular lenses: two-year follow-up.
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36. Dick HB, Alio JA, Bianchetti M, et al. Toric phakic intraoc-
ular lens: European multicenter study. Ophthalmology.
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37. Budo C, Hessloehl JC, Izak M, et al. Multicenter study of
the Artisan phakic intraocular lens. J Cataract Refract Surg.
2000;26:1163-1171.
38. Dejaco-Ruhswurm I, Scholz U, Pieh S, et al. Long-term
endothelial changes in phakic eyes with posterior chamber
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39. Menezo JL, Cisneros AL, Rodriguez-Salvador V.
Endothelial study of iris-claw phakic lens: four year follow-
up. J Cataract Refract Surg. 1998;24:1039-1049.
40. Arne JL, Lesueur LC. Phakic posterior chamber lenses for
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J Cataract Refract Surg. 2000;26:369-374.
41. Sanders DR, Vukich JA, ICL in Treatment of Myopia Study
Group. Incidence of lens opacities and clinically significant
cataracts with the implantable contact lens: comparison of
two lens designs. J Refract Surg. 2002;18:673-682.
42. Bloomenstein MR, Dulaney DD, Barnet RW. Posterior
chamber phakic intraocular lens for moderate myopia and
hyperopia. Optometry. 2002;73:435-446.
43. The Implantable Contact Lens in Treatment of Myopia
(ITM) Study Group. US Food and Drug Administration trial
of the implantable contact lens for moderate to high
myopia. Ophthalmol. 2003;110:255-266.
44. Uusitalo RJ, Aine E, Sen NH, et al. Implantable contact lens
for high myopia. J Cataract Refract Surg. 2002;28:29-36.
45. Hoyos JE, Dementiev DD, Cigales M, et al. Phakic refrac-
tive lens experience in Spain. J Cataract Refract Surg.
2002;28:1939-1946.
46. Maloney RK, Nguyen LH, John ME, et al. Artisan phakic
intraocular lens for myopia: short-term results of a prospec-
tive, multicenter study. Ophthalmology. 2002;109:955-964.
47. Malecaze FJ, Hulin H, Bierer P, et al. A randomized paired
eye comparison of two techniques for treating moderately
high myopia: LASIK and Artisan phakic lens. Ophthalmol-
ogy. 2002;109:955-964.
48. Pesado PM, Ghiringhello MP, Tagliavacche P. Posterior
chamber collamer phakic intraocular lens for myopia and
hyperopia. J Refract Surg. 1999;15:415-423.
49. Sanders DR, Martin RG, Brown DC, et al. Posterior cham-
ber phakic intraocular lens for hyperopia. J Refract Surg.
1999;15:415-423.
50. Alió JL, Mulet ME, Shalaby AMM. Artisan phakic intraocu-
lar lens for hyperopia. J Refract Surg. 2002;18:697-707.
51. Alió JL, Mulet ME, Shalaby AMM. Artisan phakic intraocu-
lar lens for high myopia. J Refract Surg. 2001;17:634-640.
52. Landesz M, van Rij G, Luyten G. Phakic intraocular lens for
high myopia. J Refract Surg. 2001;17:634-640.
53. Pérez-Santonja JJ, Iradier MT, Sanz-Iglesias L, et al.
Endothelial changes in phakic eyes with anterior chamber
intraocular lenses to correct high myopia. J Cataract Refract
Surg. 1996;22:1017-1022.
54. Alió JL, de la Hoz F, Ruiz-Moreno JM et al. Cataract surgery
in highly myopic eyes corrected by phakic anterior cham-
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2000;26:1303-1311.

Implantable Contact Lenses
John A. Vukich, MD and Donald R. Sanders, MD, PhD
The Implantable Contact Lens (ICL) (STAAR Surgical
AG, Nidau, Switzerland) is a flexible, posterior chamber
phakic intraocular lens (IOL) for the correction of myopia
and hyperopia.1-35 The lens is designed to rest in the cil-
iary sulcus and is vaulted to avoid contact with the natural
crystalline lens. It is manufactured by STAAR Surgical AG
and is made of a proprietary collagen polyhema copoly-
mer.
The first implants of the STAAR ICL were performed in
1993. In May 1997, the ICL was granted the European
Conformité Européenne (CE) mark of approval and
became available in European Union countries and others
that recognize the CE mark. In February 1997, STAAR
Surgical was allowed an investigational device exemption
(IDE) to begin United States clinical trials for premarket
approval by the US Food and Drug Administration (FDA).
While long-term safety continues to be monitored, it is
clear that short-term success is directly related to surgical
technique at the time of implantation. Preservation of the
natural crystalline lens requires deliberate and meticulous
techniques. The following description details the steps
necessary to successfully insert and position the ICL.
PREOPERATIVE PLANNING
Patient Selection
The ICL offers a noncorneal option for refractive cor-
rection. Current versions of the ICL are available between
-3.00 and -20.00 diopters (D) and +1.50 to +20.00 D. The
US clinical trials of the spherical versions of the ICL were
12 Chapter
limited to patients with less than 2.50 D of pre-existing
astigmatism. A toric model, which will correct up to 6 D
of astigmatism, is in clinical trials. The ICL’s extended
range of correction offers a compelling alternative for
patients outside the accepted range of laser in-situ ker-
atomileusis (LASIK). Ultimately, its use in lower power
corrections may become routine provided that the long-
term safety profile remains acceptable.
Preoperative Examination
An accurate refraction and complete eye examination is
necessary preoperatively. A standard manifest and cyclo-
plegic refraction is the basis for the calculation of the
power of the selected implant. Using a standard vertex dis-
tance conversion formula, software supplied by the manu-
facturer will compute the ICL power in D at the ciliary sul-
cus plane. The ICL is manufactured in 11.0-, 11.5-, 12.0-,
12.5-, and 13.0-mm lengths. Correct sizing of the ICL is
necessary to achieve proper positioning and clearance
over the natural crystalline lens. One of the inherent diffi-
culties of proper ICL sizing is determining the true sulcus
diameter. Because the sulcus cannot be directly visualized,
the anatomic correlation between the limbus and sulcus is
used. White-to-white measurement (W-to-W) is used to
estimate the diameter of the ciliary sulcus and to deter-
mine the desired length of the ICL. For myopic patients,
0.5 mm is added to the W-to-W length and for hyperopic
correction, the ICL length is the same as the W-to-W. The
fit of the ICL is an important factor in the safety profile of
the lens, and care should be exercised in obtaining the
measurement of W-to-W. Automated devices, such as
122 Chapter 12
Orbscan II (Bausch & Lomb Surgical, Rochester, NY) or
IOL Master (Carl Zeiss Meditec, Dublin, Calif), use edge
detection technology and generally provide reliable meas-
urements. Conditions such as arcus senilis and pterygium
can interfere with automated measurements, and it is rec-
ommended that all W-to-W measurements be confirmed
by calipers. Gauge-type devices are prone to errors of par-
allax and are not generally accurate enough to reliably size
an ICL.
The anterior chamber depth (ACD) is measured from
the corneal endothelium to the anterior surface of the
crystalline lens. This can be done optically as with an
Orbscan II or with A-scan ultrasound. Deep anterior
chambers facilitate ICL insertion and positioning. The ini-
tial experience of any surgeon should be limited to
patients with a minimum ACD of 2.80 mm as measured
from the corneal endothelium. With experience, chamber
depths as low as 2.60 mm can be treated. The anterior
chamber angle should be grade II or greater with
gonioscopy. No evidence of cataract should be present. A
fundoscopic exam is indicated to look for pre-existing reti-
nal tears or holes.
Peripheral Iridectomy
A peripheral iridectomy or iridotomy is required to
prevent pupillary block. The timing of the iridectomy,
either preoperatively or at the time of lens insertion, is a
matter of debate among ICL users. By far the most com-
mon technique, and that which is recommended by the
manufacturer, is to perform a neodymium:yttrium-alu-
minum-garnet (Nd:YAG) iridotomy 7 to 14 days prior to
surgery. Two iridotomies, 0.2 mm in size, are placed supe-
riorly 90 degrees apart. Paired iridotomies insure that at
least one remains patent in the event the footplate of the
ICL should occlude the other. Following the laser irido-
tomies, the patient is instructed to use prednisolone
acetate 1% drops four times per day for 7 days. Surgical
iridectomies at the time of ICL implantation have met with
mixed success. Some of the problems associated with sur-
gical peripheral iridectomies (PIs) include pigment accu-
mulation on the surface of the implant and increased early
postoperative inflammation. Of even greater concern has
been the association of surgical iridectomies with traumat-
ic cataract and zonular disruption. If the surgeon elects to
do peripheral iridectomies as a primary procedure at the
time of ICL insertion, it must be understood that a patent
opening is mandatory once the pupil has been constricted.
Preoperative Medications
As with modern cataract surgery, adequate pupil dila-
tion and ocular anesthesia facilitate the ICL procedure.
Patients are pretreated with diclofenac drops four times
per day for 2 days prior and ofloxacin drops four times per
day for 1 day prior to surgery. Tropicamide 1% drops and
neosynephrine 2.5% drops are administered every 10 min-
utes for three applications prior to surgery. The ICL inser-
tion requires a minimum pupil size of 7.0 mm at the time
of surgery.
Topical anesthetic without intracameral lidocaine pro-
vides adequate anesthesia. Topical bupivacaine 0.75%
(Abbott Laboratories, Chicago, Ill) and lidocaine 2%
drops (Abbott Laboratories, Chicago, Ill) applied just prior
to surgery are sufficient for most patients. Use of intraoc-
ular lidocaine has been associated with partial loss of
mydriasis and has proven unnecessary for patient comfort.
Peribulbar anesthetic is an acceptable alternative and may
be preferred in the early phase of a surgeon’s experience. It
is worth pointing out that any number of pharmacological
regimens will achieve the same result of a maximally dilat-
ed pupil and anesthesia.
IMPLANTABLE CONTACT
LENS PREPARATION
Loading of the Implantable
Contact Lens Into the Cartridge
Loading of the ICL into the injection cartridge is an
important part of the operation and should be performed
by the surgeon under the operating microscope.
Predictable delivery of the lens into the anterior chamber
depends in large part on the care with which the implant
is loaded.
The injector cartridge is filled with balanced salt solu-
tion (BSS) and then partially filled with Ocucoat (Storz
Ophthalmics, Clearwater, Fla). The combination of BSS
and Ocucoat minimizes friction between the ICL and the
walls of the cartridge (Figure 12-1). Once the cartridge has
been prepared, it is set aside and the ICL is removed from
the saline solution in which it is packaged. Prolonged air-
drying of the ICL reduces lens flexibility and should be
avoided. The lens is inspected under the microscope to
identify the positioning marks on the leading right and
trailing left footplate (Figure 12-2). This orientation indi-
cates the correct side up for the implant. The ICL is man-
ufactured with a predetermined vault to clear the natural
lens, and proper anterior-posterior orientation is neces-
sary. The lens is positioned in the loading chamber of the
injector in a convex orientation with the edges of the ICL
beneath the lip of the cartridge (Figure 12-3). There are
two central axis markers along the long axis of the implant.
These landmarks are used to adjust the lens in a straight
line down the shaft of the cartridge.
Once the lens is positioned in the open loading area of
the injector, it is carefully grasped with a long, fine verti-
cal action forceps. The lens is secured along the long axis

Figure 12-1. BSS followed by Ocucoat is used to prefill the injec-
tor prior to loading the ICL.
Figure 12-3. The ICL should be convex in the base of the car-
tridge with both edges tucked below the lip.
across the optic for 75% of its length with the forceps.
Using a slight downward movement, the lens is advanced
into the barrel of the cartridge (Figure 12-4A). By advanc-
ing and retracting the lens slightly in a series of back and
forth movements, surface adherence with the walls of the
injector is minimized and the implant maintains the
desired orientation.
The plunger is inserted into the injector mechanism
and the loaded cartridge is locked into position. A mois-
tened foam-tipped plunger is used to advance the ICL
down the barrel to the tip of the injector (Figure 12-4B).
The clear barrel of the injector enables identification of
the positioning markers. These should be visible at the
12:00 position and be in straight alignment down the
shaft. The fully assembled injector is then placed tip down
into a container of BSS to keep the contents hydrated. Any
Implantable Contact Lenses 123
Figure 12-2. The ICL is inspected to insure that the leading right
and trailing left markers are visible on the footplates.
Figure 12-4A. A long smooth forceps is used to advance the ICL
into the barrel of the cartridge. Back and forth movements while
advancing the ICL minimize friction and aid proper orientation.
air bubbles are evacuated from the loaded cartridge with
Ocucoat. This is accomplished by inserting the viscoelas-
tic cannula into the tip of the injector and backfilling the
cartridge (Figure 12-5).
Folded Implantable
Contact Lens Geometry
The desired shape of the folded ICL is a uniform cylin-
der with equal distribution of the mass of the ICL on either
side of the midpoint of the long axis (Figure 12-6). The
cylinder formed by the loaded ICL should be free of any
twisting, which would be evident as spiral folds.
Significant torsion of the ICL within the cartridge results
in an unwanted spiral motion during lens delivery. If this
occurs, the surgeon must counter-rotate the cartridge to
prevent delivery of the ICL in an inverted position.
124 Chapter 12
Figure 12-4B. Once the ICL has been advanced into the barrel
of the injector, a hydrated foam tip plunger is used to advance
the lens.
Figure 12-6. The properly loaded ICL is free of spiral folds.
ICL Injector
Two styles of injectors are available: a screw type and a
plunger type. The screw type offers a more controlled
injection but requires a two-handed technique. The sur-
geon holds the body of the injector in his or her dominant
hand and turns the advancing screw with the other hand.
The plunger style injector can be operated with only the
dominant hand and the other hand can be used to stabilize
the globe. Either type is acceptable, and the choice is a
matter of personal preference.
The foam-tipped plunger used to advance the ICL
within the injector cartridge is supplied in a dry com-
pressed state. The tip must be immersed into BSS to
expand the sponge prior to insertion. Failure to do so
results in over ride of the plunger tip onto the implant.
The subsequent expansion of the tip may entrap the
implant and interfere with release of the ICL into the eye.
Soaking of the plunger tip for 30 seconds in BSS prior to
advancing the ICL eliminates this potential difficulty.
Figure 12-5. Ocucoat is used to backfill the injector to remove
trapped air bubbles.
OPERATIVE TECHNIQUE
The operative technique contains many elements famil-
iar to cataract surgeons. None of the individual steps are
difficult for an experienced surgeon, but all require precise
execution.
Anesthesia
A sterile field is obtained using a standard prep and
drape appropriate for intraocular surgery. ICL surgery
should be performed in a fully equipped surgery suite
under controlled conditions with monitored intravenous
anesthesia. Anesthesia consists of topical 0.5% tetracaine
and 0.75% bupivacaine drops administered just prior to
surgery. Intravenous access is established and sedation is
titrated to patient comfort. Minimal use of intravenous
Versed (Roche Pharmaceuticals, Nutley, NJ) has proven
effective for most patients, taking care to avoid overseda-
tion. The intended level of sedation results in a conscious
and cooperative patient. Light induced sleep with the
attending risk of uncontrolled awakening during the oper-
ation should be avoided.
Surgical Approach
The ICL is well-suited to a temporal clear cornea
approach. Unlike cataract surgery, the angle of entry into
the anterior chamber must remain parallel to the plane of
the iris. A temporal approach provides ideal exposure for a
level working plane. Superior incisions, working over the
brow, tend to favor a more posteriorly angled entry. This
hinders instrument movement within the anterior chamber
and increases the risk of unintended contact with the ante-
rior lens capsule.

Figure 12-7. A diamond knife is used to create two paracentesis
incisions. Controlled entry into the anterior chamber and mini-
mum advancement of the blade are used to protect the lens cap-
sule.
Figure 12-9. A self-sealing 3 mm by 2 mm clear cornea incision
is made from a temporal approach.
Paracentesis
A clean and sharp diamond knife facilitates a controlled
entry into the anterior chamber. Paired 1.0-mm paracente-
sis incisions are placed at the 6:00 and 12:00 positions
(Figure 12-7). Care must be taken to enter the chamber in
a slow, controlled manner. A dull or debris-laden blade can
lead to corneal compression prior to anterior chamber
penetration. Entry of the chamber any further than is nec-
essary to just clear the shoulder of the blade risks inadver-
tent touch or laceration of the anterior capsule.
Injection of Viscoelastic
Once both paracentesis ports have been made, vis-
coelastic is injected into the anterior chamber. Ocucoat or
another low molecular weight, noncohesive viscoelastic is
preferred due to the minimal resistance it offers to unfold-
ing of the implant in the anterior chamber. Higher molec-
ular weight agents can cause prolonged unfolding time or
interfere with positioning of the ICL. The injection can-
Implantable Contact Lenses 125
Figure 12-8. Ocucoat is injected with the tip of the cannula just
inside the paracentesis. The eye should be moderately firm with
slight posterior displacement of the iris-lens diaphragm
nula is carefully positioned through the paracentesis, mak-
ing sure the tip clears Descemet’s membrane but does not
extend over the crystalline lens (Figure 12-8). In cataract
surgery it is common practice to cross the anterior cham-
ber and inject viscoelastic as the cannula is withdrawn. In
ICL surgery the cannula tip should not extend more than
1 mm beyond the wound; to do so risks unintentional
touch of the anterior lens capsule. Ocucoat is injected
until the iris-lens diaphragm shifts backward slightly and
the eye is moderately firm. The tip of the cannula must
clear the inside lip of the corneal wound but not extend
unnecessarily into the anterior chamber. It is worth keep-
ing in mind that failure to insert the cannula tip far enough
into the anterior chamber and injection of viscoelastic
within the paracentesis track risks viscodissection of
Descemet’s membrane and endothelial detachment.
Corneal Incision
The incision is made at the temporal clear cornea using
the same architecture as for cataract surgery (Figure 12-9).
A cord length of 3.0 to 3.2 mm with a 2.0-mm tunnel pro-
vides adequate room for the lens injector and a secure self-
sealing closure. A sharp diamond knife allows controlled
entry into the anterior chamber. Additional Ocucoat may
be injected following completion of the wound to main-
tain a deep anterior chamber.
Insertion of the ICL
The preloaded injector mechanism is brought into the
operative field, and the tip of the cartridge is inserted into
the clear cornea wound (Figure 12-10A). The surgical
plane is parallel to the iris, avoiding contact with the
corneal endothelium and anterior lens capsule. A slow
advance-and-pause tapping motion is used to direct the
ICL into the anterior chamber. No attempt should be
made to direct the leading footplates of the ICL under the
iris. A positioning mark is located on the leading right and
126 Chapter 12
Figure 12-10A. The injector cartridge is placed just inside the
wound.
Figure 12-11. Once the ICL is inside the anterior chamber,
Ocucoat is used to refill the chamber and push the implant pos-
terior.
trailing left footplate. When one-half to three-quarters of
the ICL is out of the injector cartridge, a slow unfolding of
the implant will start (Figure 12-10B). The upward unfold-
ing of the ICL should be symmetric along the long axis of
the implant. The care used preoperatively to load the ICL
will be evident in a controlled delivery. To insure proper
anterior-posterior orientation of the ICL within the anteri-
or chamber, any spiraling of the implant as it leaves the
cartridge must be neutralized by counter-rotation of the
injector by the surgeon. Once the ICL is situated in the
anterior chamber, additional Ocucoat is injected to deep-
en the chamber and direct the implant posteriorly (Figure
12-11). If the ICL should enter the eye upside-down, no
attempt should be made to reposition it inside the eye.
The implant should instead be removed and reinserted.
Removal of the ICL is accomplished through the same
incision using two smooth forceps with a hand-over-hand
technique. The implant is pliable enough to allow easy
removal through the same incision (Figure 12-12).
Figure 12-10B. The ICL is slowly injected into the anterior cham-
ber using an advance-and-pause tapping motion. If the lens starts
to twist, the cartridge can be rotated to insure right side up ori-
entation.
Figure 12-12. The ICL can be easily removed through a 3-mm
incision by grasping the edge of the implant with a smooth for-
ceps and using a hand-over-hand technique to withdraw the
lens.
Positioning of the Implantable Contact Lens
Once in the eye, the ICL must be repositioned posteri-
or to the iris plane. The paracentesis incisions are used to
provide access to the ICL. This avoids gaping of the pri-
mary wound and loss of chamber depth. The leading or
nasal footplates are positioned first. If any difficulty with
pupil size or positioning should occur, this will leave the
footplates closest to the wound available for removal of the
ICL. When working inside the eye, the central 6 mm of the
crystalline lens is considered the “no touch zone.” All
instruments within the anterior chamber should be kept to
the peripheral area outside of the central 6 mm. Several
instruments have been designed to position the ICL poste-
rior to the iris; all utilize surface contact with the ICL and
light posterior pressure to direct the footplates. The
Vukich ICL Manipulator (American Surgical Instruments
Corporation, Westmont, Ill, AE-2531) has a paddle-shaped

Figure 12-13. The ICL manipulator is inserted through the side
port incision. Using gentile posterior pressure, the footplates are
tucked one at a time under the iris. Care should be taken to
avoid crossing the central optical zone and to avoid touching the
crystalline lens.
Figure 12-14B. The diamond shaped axial indicator mark on the
toric ICL is best visualized in red reflex.
tip with a lightly textured surface to increase frictional grip
with the implant. Other instruments, including the Deitz
Tucker (Duckworth and Kent, Hertforshire, England, 6-
479) and Pallikaris Olive Tip Positioner (Duckworth and
Kent, 6-481), have been developed for the same purpose.
With the ICL manipulator in contact with the footplate,
the proper motion is gentle posterior pressure combined
with slight rotation of one clock hour or less. This maneu-
ver is repeated over each corner of the implant until all four
footplates are posterior to the iris plane (Figure 12-13). The
myopic ICL should not be rotated once placed behind the
iris. Adjustment of the implant, if necessary, is accom-
plished by a gentle nudge at the junction of the footplate
and optic. The delicate touch used for all of the intraocular
portions of the surgery has lead to the term “butterfly sur-
gery.” This concept of deliberate movement and a soft
Implantable Contact Lenses 127
Figure 12-14A. External view of a toric ICL 1 year following
implantation.
hand is the key to avoiding complications. It is important
to make certain that the toric ICL is implanted in the cor-
rect orientation (Figure 12-14).
Removal of Viscoelastic
Once the footplates are visually confirmed to be poste-
rior to the iris, the pupil is pharmacologically constricted
with Miochol (Novartis, Cambridge, Mass). Irrigating the
anterior chamber with BSS on a 27-gauge cannula through
the wound is generally sufficient to flush the Ocucoat
from the eye. Automated irrigation-aspiration has not
proven necessary and risks dislocation of the ICL.
Postoperative Medications
The wound is tested to confirm a self-sealing closure, and
topical dexamethasone (4mg/mL) and cefazolin (100 mg/
0.5 cc) are applied. The patient is sent home on ofloxacin
four times a day for 1 week and tobramycin/dexamethasone
four times a day tapering over a 2-week schedule.
Postoperative Care
The patient is rechecked in the office between 2 to 4
hours following surgery. Observations include centration
of the implant and measurement of intraocular pressure
(IOP). Incomplete iridectomies or retained viscoelastic
can cause IOP elevation. IOPs greater than 20 mmHg
should be treated medically. Topical aproclonidine 1%
drops and pilocarpine 1% is usually sufficient to lower the
IOP. Rarely, the paracentesis must be burped at the slit
lamp or an inadequate peripheral iridectomy enlarged with
the Nd:YAG laser to control IOP.
Efficacy of the Implantable Contact Lens
Three-year experience from the US Phase III clinical
trial provides the best available analysis of the intermedi-
ate term safety and efficacy of the ICL. Fifteen centers par-
ticipated in the evaluation of the Version 4 ICL for
myopia. A total of 526 eyes were analyzed at 3 years. The
128 Chapter 12
Figure 12-15. At 3 years postoperatively, 95% of eyes treated
with the ICL achieved 20/40 or better uncorrected acuity.
Figure 12-16B. A scatter plot of the attempted vs achieved result
demonstrates full correction of myopia up to -17.00 D with
anticipated undercorrection between -17 and -20.00 D.
mean preoperative spherical equivalent was -10.05 D,
ranging from -3.00 to -20.00 D. All patients had less than
2.5 D of pre-existing astigmatism.
EFFECTIVENESS OUTCOMES
Key efficacy outcomes are stratified into three groups
by preoperative manifest refractive spherical equivalent
(MRSE). Results of the myopic ICL clinical investigation
provide definitive substantiation of the overall effective-
ness of the ICL to correct moderate to high myopic refrac-
tive errors.
ALL EYES
For the subset of eyes with preoperative best spectacle-
corrected visual acuity (BSCVA) 20/20 or better and tar-
Figure 12-16A. At 3 years postoperatively, 88% of eyes treated
with the ICL were within ⫾ 1.00 D of the attempted correction.
geted for emmetropia (⫾ 0.5 D), the proportion of eyes
with 20/40 or better uncorrected visual acuity (UCVA) at
24 and 36 months, respectively, was 93.4% and 94.7%
(Figure 12-15). The proportion of eyes with UCVA 20/20
or better was 59.6% at 24 months and 59.3% at 36 months
postoperatively. For the overall myopic ICL PMA Cohort,
MRSE within 1.0 D was achieved in 90.1% of eyes at 24
months and in 88.2% of eyes at 36 months, as compared
to the FDA target of 75% (Figure 12-16). Predictability of
the MRSE within 0.50 D was 66.1% at 24 months and
67.5% at 36 months after ICL surgery, comparing favor-
ably with the FDA target of 50%.
PATIENT SATISFACTION
Subjectively, at 24 months, 94.3% of patients were
very/extremely satisfied, with only one patient unsatisfied
(0.2%) (Figure 12-17). Similarly, 92.1% were
very/extremely satisfied at 36 months (0.6% unsatisfied).
Stratified by Preoperative Mean
Refractive Spherical Equivalent
For the subset of eyes with preoperative BSCVA of
20/20 or better and targeting emmetropia at 3 years,
98.3% of eyes in the <7 D group, 92.8% of eyes in the
>7 to 10 D group, and 93.8% of eyes in the >10 D group
had UCVA of 20/40 or better. UCVA 20/20 or better was
achieved by 72.4% of eyes in the <7 D group, by 62.7%
of eyes in the >7 to 10 D group, and by 37.5% of eyes in
the >10 D group. At 36 months, attempted vs achieved
MRSE outcomes were within 1.0 D in 97.2% of the <7 D
group, 93.1% of the >7 to 10 D group, and 80% of the
>10 D group compared to the overall FDA target of 75%
and >7 D target of 60%.

Figure 12-17. A high level of patient satisfaction with the ICL
was reported at all visits.
Predictability of the refractive outcome also exceeded
the FDA target values for all three dioptric groups. For the
myopic ICL cohort, 84.7% of the <7 D group, 71.0% of
the >7 D to 10 D group, and 56.9% of the >10 D group
were within 0.50 D of the target refraction at 36 months
compared to the FDA targets of 50% for all eyes and 30%
for eyes with >7 D of refractive error.
Stratified by Preoperative Mean
Refractive Spherical Equivalent
Subjective patient satisfaction was rated as
very/extremely satisfied in 95.8% of cases in the <7 D
group, 94.3% in the >7 D to 10 D group, and 88.4% in the
high myopia group (>10 D). None of the patients in both
the low and middle myopic groups reported being unsatis-
fied. Only two cases (1.4%) reported being unsatisfied in
the high myopia group (>10 D).
Achieved vs intended correction is summarized in
Figure 12-16. At 3 years postoperatively, 88% of patients
were within ⫾ 1.00 D and 98% within ⫾ 2.00 D of
intended correction. Overall UCVA at the patient’s last
visit was 20/40 or better in 95% and 20/25 or better in
74% of eyes. One or more lines of improved best specta-
cle-corrected acuity were observed in 38% and two or
more lines in 6.5% of patients. Uncorrected postoperative
acuity was equal to or exceeded preoperative best specta-
cle correction in 57% of patients.
LENS OPACITY ANALYSIS
Induced crystalline lens opacity as a result of surgical
trauma at the time of implantation, microtrauma from the
ICL, and potential metabolic changes have been carefully
analyzed. Much has been learned from the early experi-
ence with the ICL.34 Sizing, fit, and geometry are impor-
tant variables in the safety profile of the lens. The initial
Implantable Contact Lenses 129
versions of the ICL document the evolution of our under-
standing of how a phakic IOL can safely occupy the
potential space anterior to the natural crystalline lens. The
prototype version 3 (V3) ICL lens design was responsible
for many of the lens opacities reported in the early experi-
ence with the ICL before being replaced by version 4
(V4).23 The basic difference between the V3 and V4 ICL
is in the vaulting characteristics. The V4 lens has an addi-
tional 0.5 to 0.6 mm of anterior vault depending upon
dioptric power and haptic length. This additional clear-
ance has proven to have a beneficial effect. Lens opacities
that appear early (<90 days postoperatively) following
implantation of an ICL are more frequently than not
asymptomatic and most likely due to surgically induced
trauma. There is a strong association between anterior sub-
capsular opacities and removal and reinsertion of the ICL
on the day of surgery, which suggests surgical trauma as a
factor in their development. Early anterior subcapsular
opacities tend to be focal and nonprogressive and occur in
approximately 2% of patients, but result in clinically sig-
nificant cataracts in less than 1% of cases. The develop-
ment of nonvisually significant traumatic lens opacities
appears to be related to surgeon experience. Of the early
lens opacities observed in the US clinical trials, all but one
were among the first seven ICLs implanted by any sur-
geon, suggesting a learning curve for the use of the lens.
ICL removal and reinsertion during surgery or on the
same day of surgery as a result of the ICL being implanted
upside-down has been reported in up to 2% of patients.
The subsequent additional manipulation has been associ-
ated with a higher rate of anterior subcapsular lens opaci-
ty. In the US clinical trial, of the six eyes developing ante-
rior subcapsular opacities after removal and reinsertion,
four (67%) of the opacities were seen within the first post-
operative week and all were first seen within 3 months of
surgery. This highly suggests surgical trauma as the most
likely etiology of the lens opacities.
The time course of first appearance of observed anterior
subcapsular opacities shows that the majority of changes
occur in the first 12 months. Half of them were first seen
by the first postoperative week, 79% by 6 months, 93% by
1 year, and 100% by 2 years postoperatively.
QUALITY OF VISION WITH THE
IMPLANTABLE CONTACT LENS
Patients subjectively rate the quality of visual acuity
with the ICL very highly. Objective comparison of visual
quality by measuring postoperative wavefront aberrations
allows us to compare the image quality due to higher-
order aberrations. In one published study, a comparison of
the measured coma and spherical aberration in postopera-
tive LASIK and ICL eyes demonstrated significantly less of
these higher-order aberrations.22 While the magnitude of
130 Chapter 12
Figure 12-18B. A comparison of the effect on image quality from
induced spherical aberration observed with the ICL vs LASIK.
Figure 12-18A. A comparison of the effect on image quality from
induced spherical aberration observed with the ICL vs LASIK.
aberration is useful for a quantitative comparison of out-
comes, the effect on image quality using image simulations
provides a qualitative comparison that is useful. The results
indicate that spherical aberration and coma are the major
differences between post-LASIK and phakic IOL higher-
order aberrations, and simulated retinal images can be used
to visualize the effects of these differences on vision
(Figure 12-18).
CONCLUSION
The recovery of visual acuity is rapid with the ICL and
commonly the quality of vision is excellent just minutes
after surgery. Many reports documenting the efficacy of
the ICL have been published. Short-term results with the
ICL have been encouraging, and collamer ICLs have been
relatively free of complication. Anterior subcapsular opac-
ities have been reported, primarily in patients with incor-
rectly sized implants, inadequate ICL vault, or silicone
material. Bioptics, which combines LASIK and the ICL for
extreme cases of myopia, has also shown promise.31
Established long-term safety and experience will ultimate-
ly influence the range of correction for which the ICL is
offered. Provided the overall incidence of complications
remains low, it seems likely that the ICL will gain
increased acceptance as an alternative to corneal refractive
procedures.
10. Jimenez-Alfaro I, Benitez del Castillo JM, Garcia-Feijoo J, et
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14. Menezo JL, Peris-Martinez C, Cisneros A, et al. Posterior
chamber phakic intraocular lenses to correct high myopia: a
comparative study between STAAR and Adatomed models.
J Refract Surg. 2001;17(1):32-42.
15. Pesando PM, Ghiringhello MP, Tagliavacche P. Posterior
chamber collamer phakic intraocular lens for myopia and
hyperopia. J Refract Surg. 1999;15(4):415-423.
16. Rosen ES. Phakic intraocular lenses and patient consent.
J Cataract Refract Surg. 1999;25:153-155.
17. Rosen E, Gore C. STAAR Collamer posterior chamber pha-
kic intraocular lens to correct myopia and hyperopia.
J Cataract Refract Surg. 1998;24(5):596-606.
18. Sanders DR. Actual and theoretical risks of visual loss fol-
lowing use of the implantable contact lens (ICL) for moder-
ate to high myopia. J Cataract Refract Surg. In press.
19. Sanders DR, Vukich JA. Comparison of implantable contact
lens (ICL) and laser assisted in-situ keratomileusis (LASIK)
for moderate to high myopia. Cornea. In press.
20. Sanders DR, Brown DC, Martin RG, et al. Implantable con-
tact lens for moderate to high myopia: Phase I FDA clinical
study with 6 month follow-up. J Cataract Refract Surg.
1998;24(5):607-661.
21. Sanders DR, Vukich JA. The Implantable Contact Lens in
Treatment of Myopia (ITM) Study Group. US Food and
Drug Administration clinical trial of the implantable contact
lens for low myopia. J Refract Surg. In press.
22. Sarver EJ, Sanders DR, Vukich JA. Comparison of image
quality for high myopes corrected with laser in-situ ker-
atomileusis and phakic intraocular lens. J Refract Surg. In
press.
23. The Implantable Contact Lens in Treatment of Myopia
(ITM) Study Group. Incidence of lens opacities and clini-
cally significant cataracts with the implantable contact lens
(ICL): comparison of 2 lens designs. J Refract Surg.
2002;18:673-682.
Implantable Contact Lenses 131
24. The Implantable Contact Lens in Treatment of Myopia
(ITM) Study Group. Postoperative inflammation following
implantation of the implantable contact lens. Ophthalmol-
ogy. In press.
25. The Implantable Contact Lens in Treatment of Myopia
(ITM) Study Group. US Food and Drug Administration
clinical trial of the implantable contact lens for moderate to
high myopia. Ophthalmology. 2003;110:255-266.
26. Trindade F, Pereira F. Cataract formation after posterior
chamber phakic intraocular lens implantation. J Cataract
Refract Surg. 1999;24(12):1661-1663.
27. Trindade F, Pereira F. Exchange of a posterior chamber pha-
kic intraocular lens in a highly myopic eye. J Cataract
Refract Surg. 2000;26:773-776.
28. Trindade F, Pereira F, Cronemberger S. Ultrasound biomi-
croscopic imaging of posterior chamber intraocular lens.
J Refract Surg. 1998;14(5):497-503.
29. Uusitalo RJ, Aine E, Sen NH, Laatikainen L. Implantable
contact lens for high myopia (1). J Cataract Refract Surg.
2002;28(1):29-36.
30. Zadok D, Chayet A. Lens opacity after neodymium:YAG
laser iridectomy for phakic intraocular lens implantation.
J Cataract Refract Surg. 1999;25:592-593.
31. Zaldivar R, Davidorf JM, Oscherow S, et al. Combined pos-
terior chamber phakic intraocular lens and laser in-situ ker-
atomileusis: bioptics for extreme myopia. J Refract Surg.
2000;15:299-308.
32. Zaldivar R, Davidorf JM, Oscherow S. Posterior chamber
phakic intraocular lens for myopia of -8 to -19 diopters.
J Refract Surg. 1998;14(3):294-305.
33. Zaldivar R, Rocha G. The current status of phakic intraocu-
lar lenses. Int Ophthalmol Clin. 1996;36:107-111.
34. Zaldivar R, Ricur G, Oscherow S. The phakic intraocular
lens implant: in-depth focus on posterior chamber phakic
IOLs. Curr Opin Ophthalmol. 2000;11(1):22-34.
35. Zaldivar R, Oscherow S, Ricur G. The STAAR posterior
chamber phakic intraocular lens. Int Ophthalmol Clin.
2000;40:237-245.

The Artisan Phakic Intraocular Lens
Maria M. Braun, MD and Edward E. Manche, MD
The Artisan phakic intraocular lens (IOL) (Ophtec BV,
Groningen, Netherlands) was first introduced for the cor-
rection of high myopia. The correction of patients with
high myopia who are unhappy with spectacle or contact
lens correction presents a challenge to refractive surgeons.
Laser in-situ keratomileusis (LASIK) for the correction of
myopia greater than 6 diopters (D) involves several issues.
The accuracy and safety is less for high myopia than for
low myopia. As more tissue is removed and the optical
zone is smaller, glare and halos become more common in
high myopia. Because of excessive corneal thinning,
corneal ectasia has been reported.1 The Artisan phakic
IOL is implanted surgically and is not dependent on
corneal wound healing. Thus, the Artisan lens has the
potential for a more accurate and stable refractive correc-
tion.2 For these reasons, phakic IOLs like the Artisan lens
have presented a new and exciting alternative treatment
for high myopia and hyperopia.
HISTORY
The first iris-claw lens was used in cataract surgery for
the correction of aphakia. It has been implanted in approx-
imately 3000 aphakic eyes worldwide. Fechner and Worst
modified the iris-claw lens in 1986 into a negatively bicon-
cave lens to correct high myopia. The optic design was
changed into a convex-concave model in 1991 and was
known as the Worst myopia claw lens. The optic diameter
was also increased from 4.5 mm to 5 mm, and the some-
what prominent rim of the biconcave lens was lowered.
These changes were made to decrease the risk of damage
13 Chapter
to the endothelium and to reduce the incidence of glare.
In 1998 the name of the Worst claw lens was changed to
the Artisan lens without a change in lens design.
THE ARTISAN LENS
The Artisan phakic lens is an iris-supported IOL. The
lens haptics attach to the midperipheral, immobile iris
through a process called enclavation. In this technique, the
surgeon draws small knuckles of peripheral iris into the
pincer-like haptics. Thus, the optic lies just anterior to the
iris plane.
The Artisan lens is manufactured from Perspex CQ-UV
(ICI, London, England) polymethylmethacrylate
(PMMA). It has a vaulted design (Figure 13-1) to provide
optimal clearance between the IOL and the crystalline lens
and between the IOL and the corneal endothelium. The
overall size of the lens is 8.5 mm in length. The distance
from the edge of the optic to the corneal endothelium is
approximately 1.5 to 2.0 mm, depending on the anterior
chamber depth and the dioptric power.
Several studies have measured the intraocular position
of the Artisan lens using ultrasound biomicroscopy preop-
eratively and postoperatively. In three myopic eyes, the
anterior chamber depth was found to decrease by 28% to
34% and the distance between the crystalline lens and the
posterior surface of the IOL ranged from 0.78 to 0.93
mm.3 In four hyperopic eyes, the anterior chamber depth
ranged from 2.70 to 3.25 mm preoperatively and from
2.03 to 2.54 mm postoperatively, a decrease of about
30%.4 The distance between the anterior lens and the pos-
134 Chapter 13
Figure 13-1. Illu-
stration of the
vaulted design of
the Artisan pha-
kic IOL.
Figure 13-2B. The 5-mm optic Artisan lens (courtesy of
Ophtec USA Inc).
terior surface of the Artisan lens ranges from .35 to .79
mm. Therefore, there is a measurable space between the
crystalline lens and IOL in both hyperopic and myopic
eyes. As well, there is a decrease in the depth of the ante-
rior chamber with implantation of a lens, but the signifi-
cance of this change is not known.
There are two models of the Artisan lens. The 5-mm
lens for myopia is available in -3.0 to -23.0 D (Figure 13-
2). A 6-mm optic lens was introduced in 1997 (Figure 13-
3) and is available in -3.0 to -15.50 D. Since 1997, the
6-mm optic and 5-mm optic lenses have been available in
0.5 D increments. Both lens designs are exactly the same
and differ only in the diameter of the optic. The total
height of either lens does not exceed 0.95 mm. Lenses
with higher powers are thicker than those with lower pow-
ers and, therefore, come closer to the corneal endotheli-
um. To avoid endangering the corneal endothelium, the
6-mm diameter optic lens is made only up to -15.50 D.
Indications
Indications for the Artisan IOL include patients 18 years
or older with stabilized myopia or hyperopia, as demon-
strated by a change of less than or equal to 1.0 D for at least
12 months prior to the preoperative examination. Patients
should be in good general health and without eye disease.
Figure 13-2A. The 5-mm
optic Artisan lens (cour-
tesy of Ophtec USA Inc).
PATIENT SELECTION
The Artisan lens was first used in the treatment of
patients with high myopia. Subsequently, an Artisan lens
for high hyperopia was introduced, followed by a toric
phakic IOL for high myopes and hyperopes with astigma-
tism. These patients may be unhappy with spectacle cor-
rection, as thick lenses are required and can produce mag-
nification or minification of images, aberrations, and limi-
tation of visual field. Contact lenses are also an option, but
there are risks associated with contact lens wear.
Additionally, some patients are contact lens intolerant.
LASIK has been used to successfully treat low and mod-
erate myopia, but in high myopia several complications
have been reported, including corneal ectasia, severe night
glare, and significant loss of best spectacle-corrected visu-
al acuity (BSCVA). Clear lens extraction (CLE) has been
performed. However, eyes with high myopia have an
increased risk of retinal detachment following CLE. Young
patients undergoing CLE lose their ability to accommo-
date. For these reasons, studies have examined the Artisan
lens as an alternative treatment for high myopia, hyper-
opia, and high myopia and hyperopia with astigmatism.
CONTRAINDICATIONS
There are several contraindications to the use of the
Artisan lens, including uveitis, endothelial counts less than
2000 cells/mm2, anterior chamber depth less than 2.6 mm,
and glaucoma (Table 13-1).
PREOPERATIVE EVALUATION
Every patient considering Artisan lens implantation
should have a complete eye examination, including slit
lamp biomicroscopy, manifest and cycloplegic refraction,
gonioscopy, B-scan biometry, tonometry, corneal topog-
raphy and keratometry, and retinal examination. The
physician should look for evidence of glaucoma, uveitis, or
retinal disease. Corneal endothelial cell density should be
calculated.
 The Artisan Phakic Intraocular Lens 135

Figure 13-3B. The 6-mm optic Artisan lens (courtesy of

Ophtec USA Inc).

Figure 13-3A. The 6-mm optic Artisan lens (courtesy of Ophtec

USA Inc).

Table 13-1

RELATIVE CONTRAINDICATIONS TO THE ARTISAN LENS

• Endothelial counts less than 2000 cells/mm2
• Anterior chamber depth less than 2.6 mm
• Acute inflammation
• Glaucoma or family history of glaucoma
• Intraocular pressure >21 mmHg
• Retinal detachment or family history of retinal detachment
• Any form of cataract
• Recurrent or chronic uveitis
• Pre-existing macular degeneration
• Fixed pupil size >4.5 mm
• Abnormal iris
• Abnormal pupil
• Abnormal cornea
• Surgical difficulty at the time of surgery that might increase the potential for complication
• Under 18 years of age

SURGERY
The technique of Artisan implantation is similar to
other types of intraocular surgery. However, the process
of iris enclavation is a unique aspect of the surgery that
requires practice.
Power Calculation
The power of the lens is calculated by the van der
Heijde formula. The measurements used in this formula
are independent of axial length and include the anterior
chamber depth, the corneal curvature, and the refraction.
Power = n + n
[n/k + Ps] [n/k] – d
K is the keratometric value of the cornea (D), Ps is the
equivalent spectacle power of the corneal place (D), d is
the distance (mm) between the IOL plane and the corneal
plane, and n is the refractive index of aqueous (1.336). In
the formula, the anterior chamber depth is the distance
from the anterior corneal surface to the anterior surface of
the IOL. This distance is approximately 0.8 mm in front of
the crystalline lens. It is, therefore, necessary to subtract
136 Chapter 13

Table 13-2

VAN DER H EIJDE N OMOGRAM :

INTRAOCULAR LENS POWER NEEDED FOR EMMETROPIA
Preop Refractive AC 2.0 mm AC 2.5 mm AC 3.0 mm AC 3.5 mm
Error (D) K38 K43 K48 K38 K43 K48 K38 K43 K48 K38 K43 K48
1 1.1 1.1 1.1 1.1 1.1 1.2 1.1 1.2 1.2 1.2 1.2 1.3
2 2.2 2.3 2.3 2.3 2.4 2.4 2.4 2.5 2.5 2.5 2.6 2.6
3 3.5 3.5 3.6 3.6 3.6 3.7 3.7 3.8 3.9 3.8 3.9 4.1
4 4.7 4.8 4.9 4.8 5.0 5.1 5.0 5.1 5.3 5.2 5.3 5.5
5 6.0 6.1 6.2 6.3 6.4 6.4 6.6 6.7 6.6 6.8 7.0 6.8
6 7.3 7.4 7.5 7.5 7.7 7.9 7.8 8.0 8.2 8.1 8.3 8.6
7 8.6 8.8 8.9 8.9 9.1 9.3 9.3 9.5 9.8 9.6 9.9 10.2
8 10.0 10.2 10.4 10.4 10.6 10.8 10.8 11.0 11.3 11.2 11.5 11.9
9 11.5 11.7 11.9 11.9 12.1 12.4 12.3 12.6 13.0 12.8 13.2 13.6
10 13.0 13.2 13.4 13.4 13.7 14.0 13.9 14.3 14.7 14.5 14.9 15.4
11 14.5 14.7 15.0 15.0 15.4 15.7 15.6 16.0 16.4 16.2 16.7 17.2
12 16.1 16.4 16.6 16.7 17.0 17.4 17.3 17.8 18.3 18.0 18.6 19.1
13 17.7 18.0 18.3 18.4 18.8 19.2 19.1 19.6 20.1 19.9 20.5 21.1
14 19.4 19.7 20.1 20.2 20.6 21.0 21.0 21.5 22.1 21.8 22.5 23.2
15 21.2 21.5 21.9 22.0 22.5 23.0 22.9 23.5 24.1 23.8 24.6 25.4
16 23.0 23.4 23.8 23.9 24.4 24.9 24.9 25.5 26.2 25.9 26.7 27.6
17 24.9 25.3 25.7 25.9 26.4 27.0 26.9 27.7 28.4 28.1 29.0 29.9
18 26.8 27.2 27.7 27.9 28.5 29.1 29.1 29.9 30.7 30.4 31.3 32.3
19 28.8 29.3 29.8 30.0 30.7 31.3 31.3 32.2 33.0 32.7 33.8 34.8
20 30.9 31.4 32.0 32.2 32.9 33.6 33.7 34.5 35.2 35.2 36.3 37.5

AC = anterior chamber

0.8 mm from the anterior chamber depth as measured pre-
operatively using ultrasound.
The most commonly used method to calculate the IOL
power is the van der Heijde nomogram (Table 13-2).
Surgical Technique
The pupil should be constricted preoperatively with
1% pilocarpine to reduce pupil size and prevent damage to
the crystalline lens. General, local, or topical anesthesia
may be used. The eye should be prepped with povidone-
iodine solution. Two paracentesis sites are made at the
9:30 and 2:30 positions. These sites are needed to allow an
entry site for enclavation of the iris to secure the lens.
Therefore, the site is directed toward the midperipheral
iris instead of the center of the lens as would be done in
cataract surgery. The anterior chamber is then filled with
viscoelastic.
The axis of astigmatism should be taken into consider-
ation in choosing a wound location. The most common
wound site is superior, but the technique is the same tem-
porally. Several incision types are used: clear corneal, lim-
bal, corneoscleral, and scleral. Good wound construction
will minimize the possibility of induced astigmatism or
wound leak. A 5.0- to 5.5-mm incision is needed for inser-
tion of 5-mm optic lens, and a 6.0- to 6.5-mm incision is
needed for the 6-mm lens. After the wound is made, addi-
tional viscoelastic is instilled. The surgeon should be care-
ful not to dilate the pupil, allow viscoelastic under the iris,
or push the iris too far posteriorly, making enclavation of
the iris difficult.5
The implant is then advanced into the eye using long-
angled forceps and rotated 90 degrees to a horizontal posi-
tion in the center of the anterior chamber with a Sinskey
or Kuglan hook (Katena, Denville, NJ). The lens should be

Figure 13-4. The Artisan enclavation needle (courtesy of Ophtec
USA Inc).
centered on the pupil and held in position with the Artisan
implantation forceps during the enclavation process. An
enclavation needle (Figure 13-4) or fine iris forceps are
then used to catch a small fold of iris and engage it in the
claw of the implant (Figure 13-5). The needle or iris for-
ceps hold the fold of iris while the Artisan lens is depressed
slightly with the implantation forceps so that the claws
will automatically grasp the iris. The second haptic is then
secured to the iris in a similar fashion.
Centration of the optic should be noted. If the lens is
not well-centered, the iris can be released by pushing in
the central portion of the claw with the needle.
Repositioning and enclavation can then be performed.
One advantage of the Artisan lens over angle-fixated or
sulcus-fixated lenses is that it can be centered on the pupil,
even if the pupil is not perfectly centered in relationship to
the limbus.5
A peripheral iridotomy is performed to prevent pupil-
lary block. Alternatively, a neodymium:yttrium-aluminum-
garnet (Nd:YAG) peripheral iridotomy can be performed
postoperatively. The wound is then sutured.
Postoperatively, topical antibiotic is given, as well as
steroid and/or nonsteroidal drops.
RESULTS
Phase III US Food and Drug
Administration Trial for Myopia
The Phase III Interim Report for the Food and Drug
Administration (FDA) trial for the Artisan lens for myopia
was compiled by Ophtec in December 2002.6 This multi-
center FDA trial evaluated data from 536 eyes implanted
with the Artisan lens for myopia.
Study Population
Five hundred thirty-six eyes of 536 patients were
implanted with the Artisan lens for myopia. The mean age
of the patients was 39 years. The anterior chamber depth
ranged from 3.02 to 4.67 mm with a mean of 3.71 mm.
The incision created by the surgeon was approximately
one-third corneal, one-third scleral, and one-third limbal.
Sixty-nine percent of surgeons chose a superior location
for the wound, while 31% chose a temporal approach.
Four hundred sixteen eyes received the 6-mm optic lens,
The Artisan Phakic Intraocular Lens 137
Figure 13-5. The enclava-
tion process. The Artisan
lens is held in place with
lens forceps while the iris
is engaged in the claw of
the haptic (courtesy of
Ophtec USA Inc).
and 120 eyes received the 5-mm optic lens. The power of
the implants used ranged from -5.00 D to -20.0 D with a
mean power of -12.68 D.
Results
Patients were seen postoperatively up to 36 months.
Four hundred sixteen of 536 eyes were seen in follow-up at
6 months postoperatively. Uncorrected visual acuity
(UCVA) at 6 months was 20/40 or better in 86.8% of
patients. Three hundred fifty-seven patients were seen
12 months postoperatively, where 87.3% of eyes had
UCVA of 20/40 or better. At 6 months, 99.8% of eyes had
BSCVA of 20/40 or better, compared to 99.3% preopera-
tively.
Additional Studies
Maloney et al2 published results from patients who
received Artisan implants as part of the Phase I, II, or III
FDA trial (Table 13-3). One hundred fifty-five eyes were
included, with a mean refraction of -12.69
-3.80 D with
a range of -5 D to -22.5 D. At 6 months, 85% of eyes had
UCVA of 20/40 or better, and 90% of eyes were within
1.0 D of intended correction. At 6 months, no eye had lost
two or more lines of BSCVA.
A European multicenter study included data from 518
patients implanted with the Artisan lens for myopia.7 The
mean spherical equivalent preoperatively was -12.95

4.35 D. An UCVA of 20/40 or better was observed in
76.8% of patients. The BSCVA remained the same or
improved in 95.8% of eyes, while three eyes lost two or
more lines of acuity. One eye was due to cataract, and two
involved macular myopic degeneration. In the group with
high myopia (120 eyes, -11 to -15 D), 43.7% gained two
or more lines of BSCVA. In the group with extremely high
myopia (60 eyes, >-15 D), 63.3% or eyes gained two or
more lines of BSCVA.
Menezo et al8 compiled data from 48 eyes receiving the
original biconcave model and 46 eyes receiving the con-
cave-convex model now used. The mean preoperative
spherical equivalent was -14.73
4.31 D. At 3 years post-
operatively, 94.6% of eyes were found to have UCVA of
20/40 or better. No eyes lost two or more lines of BSCVA,
and 81.9% of eyes gained two or more lines of BSCVA. At
 138
Table 13-3

REVIEW OF REPORTED POSTOPERATIVE RESULTS AND COMPLICATIONS

Type of Lens Number Preoperative Follow-Up Percent Change Complications
Chapter 13

Used of Eyes Myopia + 1.00 D in BSCVA

Emmetropia
Menezo et al8 Worst bicon- 94 Mean -14.73 Mean 48.9 79.8 No eyes lost Iritis in three eyes
cave lens and + 4.31 D months two or more Halos 23.4%
convex-con- lines BSCVA Endothelial cell loss
cave lens 17.9% at 5 years

Perez-Santonja Worst bicon- 32 Mean -16.60 Mean 18.3 76.5 BSCVA im- Endothelial cell loss
et al17 cave lens + 6.29 D months proved overall 17.6% at 2 years
Decentration >0.5 mm
43%
Halos 56%

Fechner et al18 Worst bicon- 127 Mean -14.29 6 months to 62.1 BSCVA im- Endothelial cell loss
cave lens + 5.77 D 8 years proved overall 13.4%

Budo et al7 Artisan lens 518 Mean -12.95 6 months to 76.8 Three eyes lost Halos 7.2% to 10%
+ 4.35 D 3 years two or more Endothelial cell loss
lines 7% at 3 years
BSCVA im-
proved overall

Landesz et al9 Artisan lens 67 Mean -14.70 Mean 35 67.2 Three eyes lost Halos 22.2%
+ 4.90 D months two or more Severe anterior cham-
lines ber inflammatory
BSCVA im- reaction 1.4%
proved overall Endothelial cell loss
10.9% at 3 years

(continued)
 Table 13-3 (Continued)
Type of Lens Number Preoperative Follow-Up Percent Change Complications
Used of Eyes Myopia + 1.00 D in BSCVA
Emmetropia
Landesz et al10 Artisan lens 78 Range of -6 Mean 10.7 67.9 Two eyes lost Gain in endothelial
to -28 D months two or more cell counts at each
lines interval
BSCVA im- Halos and glare 12.8%
proved overall Anterior uveitis 3.8%

Phase III Interim Artisan lens 536 Implant power Up to 36 UCVA 20/40 BSCVA im- Glare and halos 9.1%
Results6 mean -12.68 months or better 86% proved overall Anterior chamber flare
+ 2.68 D at 2 years 23% on postoperative
day 1
Corneal endothelial
loss 3.1% at 2 years
The Artisan Phakic Intraocular Lens
139
140 Chapter 13
Figure 13-6A. The Artisan lens for hyperopia (courtesy of Ophtec
USA Inc).
3 years, 79.8% of eyes had a spherical equivalent within
1 D of the attempted correction. Twelve eyes had pre-
sented with myopia greater than -20 D with no IOLs of
such power available. When these were excluded, 91.4%
of eyes were within 1 D of attempted correction.
Landesz et al9 examined 78 eyes implanted with the
Artisan lens, 10 of which received the 6.0-mm optic lens.
Mean follow-up was 10 months. The preoperative spheri-
cal equivalent ranged from -6 to -28 D. A little over 67%
of eyes were within 1 D of emmetropia. UCVA was 20/40
or better in 88.6% of eyes. Two eyes lost two lines of
BSCVA, while most eyes had an improvement in BSCVA.
A group of 67 eyes implanted with the 5-mm optic
Artisan lens and followed for 3 years was analyzed by
Landesz et al10 Preoperative refraction ranged from
-5.40 D to -28.0 D. A little over 67% of eyes had a post-
operative spherical equivalent within 1 D of emmetropia.
UCVA was 20/40 or better in 40.9% of eyes. Change in
BSCVA showed an increase of one line or more in the
majority of eyes. Three eyes lost two or more lines of
BSCVA.
ARTISAN LENS FOR HYPEROPIA
An Artisan hyperopia lens was developed and first
implanted in 1992 (Figure 13-6). The Phase III Interim
Report of the FDA trial revealed data from 59 eyes from 38
subjects.11 All eyes received the 5-mm optic Artisan lens
for hyperopia. The mean implant power was +7.18 D with
a range of +4.0 D to +11.0 D. UCVA was 20/40 or better
in 88.2% of eyes at 6 months and 82.4% of eyes at 2 years.
At 6 months, 1 year, and 2 years, 100% of eyes had
BSCVA of 20/40 or better
Surgery-related complications were observed, such as
flare in 20.4% of eyes on postoperative day 1 but not at 3
months. Glare was reported by one patient at 1 week but
resolved. No significant endothelial cell loss was seen at
Figure 13-6B. The Artisan lens for hyperopia (courtesy of Ophtec
USA Inc).
3 years. Three patients experienced posterior synechiae. It
was found that these eyes did not initially meet the inclu-
sion criteria for the study due to peaked pupils.
Alio et al12 looked at 57 eyes of 32 patients implanted
with the Artisan lens for hyperopia. Twenty-nine of the 57
eyes had primary hyperopia (mean spherical equivalent
+6.06
1.26 D), while 28 eyes had secondary hyperopia
induced or residual following a previous corneal refractive
procedure (mean spherical equivalent +5.99
1.88 D). In
the primary hyperopia group, the mean spherical equiva-
lent postoperatively was +0.10
0.57 D. The mean
UCVA improved to a mean of 20/40. No eye lost two or
more lines of BSCVA. In the secondary hyperopia group,
the mean spherical equivalent postoperatively was +.55

1.49 D. The mean UCVA improved to a mean of 20/50.
One eye lost three lines of BSCVA, and one eye lost two
lines. Of the six eyes that lost one line of BSCVA or more,
three eyes were associated with an increase in irregular
astigmatism and three eyes experienced acute iritis with
pigment deposits on the lens surface. An acute anterior iri-
tis was observed in three eyes, which were successfully
treated with topical corticosteroids. Endothelial cell loss
was measured as 6.8% at 6 months, and 9.4% at 1 year.
Halos and glare were reported in four eyes (7%). Two eyes
showed mild decentration less than 1 mm.
TORIC ARTISAN LENS
An Artisan toric phakic IOL was developed in 1999 for
the correction of myopia or hyperopia with astigmatism
(Figure 13-7). It is available in powers from -3 to -23.5 for
myopia and from +2 to +12 for hyperopia, with cylindri-
cal correction from 1.0 to 7.0 D.
Most surgeons prefer to position the Artisan lens hori-
zontally; therefore, to accommodate this positioning tech-
nique, there are two models of toric Artisan lenses avail-
able. In model A (Figure 13-8), the torus axis runs through
the claw at 0 degrees compared to the torus axis in model
B, which is perpendicular to the line that runs through the
claws.13 For eyes with a preoperative cylinder axis
between 0 and 45 degrees or between 135 and 180
degrees, a toric lens with the axis at 0 (model A) is recom-
mended. For eyes with a cylinder axis between 45 and 135
degrees, model B is recommended. Marking the enclava-
tion sites on the iris with an argon laser before surgery or

Figure 13-7.
The Artisan
toric lens
(courtesy of
Ophtec USA
Inc).
marking the limbus at the site of the incisions to allow
introduction of the enclavation forceps has been recom-
mended.13
Results
A European multicenter study was published with data
on eyes implanted with the toric phakic Artisan IOL.13
Seventy eyes of 53 patients were studied in a prospective
fashion. Two groups were analyzed: Group A with myopia
(average preoperative spherical equivalent of -8.9
4.52
D) and Group B with hyperopia (average preoperative
spherical equivalent of +3.25
1.98 D). At 6 months,
UCVA was 20/40 or better in 88.6% of eyes. No eyes lost
lines of BSCVA. Forty-six eyes (65.7%) gained one or
more lines of BSCVA compared to preoperative BSCVA.
In all eyes, the postoperative spherical equivalent at
6 months was within 1 D of attempted correction.
Complications
Two eyes required a secondary surgery. One eye had a
wound leak, while the other required a repositioning of
the lens because of a deviation of 15 degrees from the tar-
get axis. In one eye, pigment precipitates on the optic
were seen. Four patients reported mild or moderate glare.
Mean endothelial cell loss was 4.5% at 6 months.
COMBINATION OF LASER IN-SITU
KERATOMILEUSIS AND ARTISAN FOR
THE T REATMENT OF H IGH M YOPIA
One of the challenges of correcting high myopia with
LASIK is that it is difficult to maintain a large optical zone
when attempting to correct high myopia because of exces-
sive ablation. The concept of adjustable refractive surgery
combining Artisan lens implantation with LASIK was eval-
uated by Guell et al.14 In this technique, the lamellar cut
for LASIK was made prior to implantation of the Artisan
The Artisan Phakic Intraocular Lens 141
Figure 13-8. The Artisan Toric lens (model A) with torus axis
running through the claw at 0 degrees (courtesy of Ophtec
USA Inc).
lens to avoid any possible contact between the corneal
endothelium and the anterior chamber during the micro-
keratome pass. A standard -15.00 D, 6-mm optic Artisan
lens was used in all patients followed by LASIK with a 6.5-
mm optical zone. LASIK was performed between 2 to 4
months after IOL implantation once all sutures had been
removed and the cylinder power was stable for at least
4 weeks. Twenty-six eyes of 18 patients were enrolled,
with a mean preoperative refractive error of -18.42
2.73
D, ranging from -16.0 to -23.0 Ds.
The mean postoperative spherical equivalent refraction
before LASIK was -3.42
1.62 and after LASIK was -0.38

0.65 D at 12 months. Seventy-seven percent of eyes
achieved UCVA of 20/40 or better at 1 and 2 years. All
eyes were within 1 D of emmetropia at 2 years and 80% of
eyes were within 0.5 D. No eyes lost two or more lines of
BSCVA, and 72% of eyes gained one or more lines of
BSCVA at 1 year. No statistically significant difference in
endothelial cell counts was found throughout the follow-
up period. There were a few flap complications, including
one free cap, one traumatic flap dislocation, and one short
flap. Only two patients reported visual disturbances at
night.
LASER IN-SITU KERATOMILEUSIS
COMPARED TO THE
ARTISAN LENS FOR HIGH MYOPIA
Some investigators have compared the safety and effi-
cacy of LASIK with Artisan lens implantation for the treat-
ment of high myopia. Malecaze et al15 enrolled 25
patients with moderate high myopia ranging from -8 to
-12 D in a prospective trial in which one eye received
142 Chapter 13
LASIK and the other received Artisan IOL implantation.
All eyes that underwent Artisan lens placement received
the 6-mm optic lens. The mean spherical equivalent at
1 year postoperatively was -0.74
0.67 D in the LASIK
treated eyes and -0.95
0.45 D in the Artisan treated
eyes. Sixty-four percent of the LASIK treated eyes and
60% of Artisan treated eyes were within 1 D of intended
correction at 1 year. In the LASIK eyes, the mean cylinder
power was corrected from +0.83
0.75 D to +0.42

0.55 D at 1 year. There was no correction of astigmatism
in the Artisan treated eyes. At 1 year, 80% of the LASIK
treated eyes and 60% of the Artisan treated eyes had
UCVA of 20/40 or better. This difference was not statisti-
cally significant (p = .13). Three eyes treated with LASIK
lost two or more lines of BSCVA, while no Artisan treated
eyes lost two lines. As well, six Artisan cases had improve-
ment of BSCVA, while only two LASIK cases had
improvement. The endothelial cell loss was 0.42

11.95% for LASIK and 1.76
12.05% at 1 year, a differ-
ence that was not statistically significant. No significant
difference was seen in reported halos and glare and in
reported satisfaction level between the two groups.
However, when patients were asked which eye they pre-
ferred, most patients showed a preference for the Artisan
treated eye.
Another study comparing LASIK with Artisan was con-
ducted by El Danasoury et al.16 Ninety-one eyes of 61
patients were prospectively randomized for either LASIK
or an Artisan implant for the correction of myopia ranging
from -9.00 to -19.50 D. In 18 patients, one eye received
Artisan and one eye underwent LASIK. Between months
3 and 6, seven LASIK eyes and one Artisan eye underwent
enhancement procedures. At 1 year, there was no statisti-
cally significant difference between the mean spherical
equivalent of each group: -0.64
0.8 D in Artisan eyes
and -0.87
0.8 D in LASIK eyes. A little over 65% of
Artisan eyes and 58.5% of LASIK eyes were within 1 D of
emmetropia. There was a statistically significant change in
mean refractive cylinder power in the LASIK eyes (1.2

0.87) compared to the Artisan eyes (0.60
0.81). At
1 year, 88.4 % of Artisan eyes and 58.5% of LASIK eyes
had UCVA of 20/40 or better. No Artisan eyes and five
LASIK lost two or more lines of BSCVA. Seven Artisan
eyes and one LASIK eye gained two or more lines of
BSCVA. There was no significant difference in the mean
endothelial cell loss in the two groups (0.7%
1.1 for the
Artisan group and 0.3%
0.9 for the LASIK group).
Fourteen percent of patients reported symptomatic night
glare. One eye in the Artisan group who reported severe
night glare had exchange of a 5-mm optic lens for a 6-mm
optic lens and reported a reduction of the glare. Seven
eyes treated with LASIK reported severe night glare.
The subgroup of 18 patients who had one eye treated
with LASIK and the other with the Artisan lens complet-
ed questionnaires postoperatively with questions regard-
ing satisfaction and preference. Thirteen of 18 (72.2%)
patients preferred the Artisan procedure, and the reason
given was the better quality of vision.
In conclusion, Artisan lens implantation has favorable
results when compared to LASIK for high or moderately
high myopia. No Artisan eyes lost two or more lines of
BSCVA, and more Artisan eyes gained lines in BSCVA.
Though there was no correction for astigmatism with the
Artisan lens for myopia, the patients preferred the eye that
had received the Artisan lens.
COMPLICATIONS
There are several potential complications with implan-
tation of an Artisan lens, including effect on the corneal
endothelium, anterior chamber inflammation, and crys-
talline lens changes.
The Phase III FDA trial data for the Artisan lens for
myopia6 showed that in the early postoperative period,
some eyes experienced complications related to surgically
induced trauma (see Table 13-3). Anterior chamber flare
was seen in 23.7% of eyes on postoperative day 1, but in
only 5.1% at 2 weeks. Corneal edema was seen in 13.5%
of eyes in the immediate postoperative period, but in only
1.4% of eyes at 2 weeks. One eye experienced pupillary
block. No eyes at 6 months showed signs of iritis, second-
ary glaucoma, or iris atrophy. There was a mean change in
endothelial cell counts of -1.11% at 12 months and -3.1%
at 24 months. Thirty-five eyes were seen at 3 years with a
mean change of +0.3%. Glare and halos were reported by
9.1% of patients at 12 months and were attributed by the
authors to decentered lenses or pupils larger than the optic
size in low light conditions.
The European Multicenter Trial7 showed endothelial
cell loss of 4.8% at 6 months, 2.4% at 2 years, and 0.7% at
3 years. Patients reported halos more frequently in the
very high myopia group (10%) compared to the moderate
myopia group (7%). Five eyes (2%) underwent reposition-
ing of a decentered lens, and eight eyes (3.2%) had a lens
exchange performed.
Menezo et al8 reported glare symptoms in 4.25% of
eyes and halos in 23.4% of eyes. Halos were twice as com-
mon in eyes receiving the biconcave model IOL, which is
no longer used. Endothelial cell loss was measured as 5.8%
at 6 months, 7.9% at 1 year, and 10.8% at 2 years. No reti-
nal detachment or cataract was seen. Maloney et al2
reported no change in endothelial cell counts at 6 months
compared to preoperative count. No eyes developed glau-
coma, angle closure, or chronic inflammation.
Landesz et al10 reported mean endothelial cell loss of
5.5 % at 6 months, 7.2% at 1 year, and 9.1% at 2 years.
One lens was recentered due to distorted images. One eye
showed a severe inflammatory reaction in the anterior

chamber, which cleared with medical treatment. One eye
developed a nuclear cataract in both eyes. Twenty-two
percent of patients reported halos.
Landesz et al9 reported a gain in endothelial cell count
postoperatively at each interval follow-up. The authors
attributed this finding to the large variation in measuring
cell density with the specular microscope used. Twelve
percent of eyes experienced halos and glare. Three eyes
were found to have anterior uveitis that resolved with
treatment. Four eyes underwent replacement of lenses: two
due to undercorrection and two due to halos with the
5-mm optic lens.
Perez-Santonja et al17 used a laser flare cell photometer
to show that flare values were significantly higher for eyes
implanted with the biconcave 5-mm lens. Halos were
reported in 56% of eyes. They also showed a decentration
greater than 0.5 mm in 43% of eyes. It is unclear how
much decentration is necessary to be visually significant.
CONCLUSION
There are many advantages of Artisan lens implantation
for high myopia. The lens is removable, and can be
exchanged if needed. The optic of the lens has better pupil
coverage than many eyes that receive LASIK treatment
with less than ideal optical zones. The use of the 6-mm
optic lens has reduced the incidence of glare compared to
patients who received the 5-mm optic lens. However, the
6-mm lens is offered only up to -15.50 D; therefore, resid-
ual myopia will need to be addressed through subsequent
corneal refractive procedures.16 Though surgeons must
currently make a 6.0- to 6.5-mm wound for insertion of
the lens, in the future a foldable Artisan lens, Artiflex, will
be available that will allow a smaller surgical wound for
lens placement.
Patients tend to prefer the quality of the vision that
Artisan implantation affords compared to LASIK and more
eyes gain BSCVA compared to LASIK.15,16 Randomized
trials have shown predictability, safety, stability, and accu-
racy in the correction of myopia by Artisan lens implanta-
tion. Concerns of postoperative loss of endothelial cell
counts and increased incidence of cataract will need to be
addressed in further long-term examination of the Artisan
lens.
REFERENCES
1. Seiler T, Koufala K, Richter G. Iatrogenic keratectasia after
laser in situ keratomileusis. J Refract Surg. 1998;14:312-317.
2. Maloney RK, Nguyen LH, John ME. Artisan phakic intraoc-
ular lens for myopia; short term results of a prospective mul-
ticenter study. Ophthalmology. 2002;109(9):1631-1641.
The Artisan Phakic Intraocular Lens 143
3. Pop M, Mansour M, Payette Y. Ultrasound biomicroscopy
of the iris-claw phakic intraocular lens for high myopia.
J Refract Surg. 1999;15(6):632-635.
4. Pop M, Payette Y, Mansour M. Ultrasound biomicroscopy
of the Artisan phakic intraocular lens in hyperopic eyes.
J Cataract Refract Surg. 2002;28:1799-1803.
5. Hardten DR. Phakic iris-claw artisan intraocular lens for
correction of high myopia and hyperopia. Int Ophthalmol
Clin. 2000;40(3):209-221.
6. 2002 Artisan Myopia Lens Annual Progress Report. Phase III
Interim Report. Groningen, Netherlands: Ophtec; 2002.
7. Budo C, Hessloehl JC, Isak M, et al. Multicenter study of
the Artisan phakic intraocular lens. J Cataract Refract Surg.
2000;26:1163-1171.
8. Menezo JL, Avino JA, Cisneros A, et al. Iris-claw phakic
intraocular lens for high myopia. J Refract Surg. 1997;13:
545-555.
9. Landesz M, van Rij G, Luyten G. Iris-claw phakic intraocu-
lar lens for high myopia. J Refract Surg. 2001;17(6):634-
640.
10. Landesz M, Worst JG, van Rij G. Long-term results of cor-
rection of high myopia with an iris-claw phakic intraocular
lens. J Refract Surg. 2002;16(3):310-316.
11. 2002 Artisan Hyperopia Lens Annual Progress Report.
Phase III Interim Report. Groningen, Netherlands: Ophtec;
2002.
12. Alio JL, Mulet ME, Shalaby AM. Artisan phakic iris-claw
intraocular lens for high primary and secondary hyperopia.
J Refract Surg. 2002;18(6):697-707.
13. Dick HB, Alio J, Bianchetti M, et al. Toric phakic intraocu-
lar lens: European multicenter study. Ophthalmology.
2002;110(1):150-162.
14. Guell JL, Vazquez M, Gris O. Adjustable refractive surgery:
6-mm Artisan lens plus laser in situ keratomileusis for the
correction of high myopia. Ophthalmology. 2001;108(5):
945-951.
15. Malecaze FJ, Hulin H, Bierer P, et al. A randomized paired
eye comparison of two techniques for treating moderately
high myopia: LASIK and Artisan phakic lens.
Ophthalmology. 2002;109(9):1623-1630.
16. El Danasoury MA, El Maghraby A, Gamali TO.
Comparison of iris-fixed Artisan lens implantation with
excimer laser in situ keratomileusis in correcting myopia
between -9.00 and -19.50 Ds. Ophthalmology.
2002;109(5):955-964.
17. Perez-Santonja JJ, Bueno JL, Zato MA. Surgical correction
of high myopia in phakic eyes with Worst-Fechner myopia
intraocular lenses. J Refract Surg. 1997;13:268-284.
18. Fechner PU, Haubitz I, Wichmann W, Wulff K. Worst-
Fechner biconcave minus power phakic iris-claw lens.
J Refract Surg. 1999;15:93-105.

CIBA Vision Phakic Refractive Lens
Gary S. Schwartz, MD and Stephen S. Lane, MD
The Phakic Refractive Lens (PRL) has been in develop-
ment since 1987.1 It was designed and initially manufactured
by Medennium, Inc (Irvine, Calif) and distributed by CIBA
Vision (Duluth, Ga). In February 2003, Medennium, Inc
transferred full ownership of the PRL technology to CIBA
Vision. The PRL is currently going through Phase III clinical
trials for the US Food and Drug Administration (FDA).
The PRL is a plate-haptic style posterior chamber pha-
kic intraocular lens (IOL). It is made of a medical-grade
high-index silicone that is soft, elastic, and hydrophobic.
The refractive index is 1.46. The material, one-piece
design, and manufacturing process are all proprietary
(Figure 14-1).
The lens is designed to float in the posterior chamber
(Figure 14-2). The footplates are not designed to support
the lens by putting pressure on the zonules or ciliary sul-
cus in a way that causes the optic to vault over the crys-
talline lens. Rather, this free-floating lens stays in position
by being gently pushed against the posterior surface of the
iris by hydrostatic forces. In this way, a layer of fluid is
always maintained between the PRL and the crystalline
lens. Pupillary block is avoided by the placement of two
peripheral iridotomies or iridectomies. The lens is self-
centering by the action of the iris sphincter on the periph-
eral ridge of the optic, which is molded onto the anterior
surface of the lens.
Because the PRL floats in the posterior chamber and the
footplates are not anchored in the sulcus, it does not have
to be sized as carefully as other lenses. Currently, only two
sizes exist: one for myopic and one for hyperopic powered
lenses. However, because the lens is not anchored, its
14 Chapter
position is probably not as stable as other posterior cham-
ber phakic IOLs that “vault” over the crystalline lens. The
PRL has been reported to rotate over time. For this reason,
it is possible that this particular lens will not lend itself to
a toric design.
Two models of PRL are being implanted: one for
myopes and one for hyperopes. The myopic PRL is
11.3 mm in length and 6.0 mm in width. The thickness of
the lens is dependent upon the power, with a maximum
thickness of 0.6 mm. The lens power range is -3 diopters
(D) to -20 D in half-diopter steps, which allows for cor-
rection of myopia up to -23.0 D. The optic diameter
ranges from 4.5 mm to 5.0 mm depending on the power.
An older myopic model (PRL 100) had an overall length of
10.8 mm. This model has been discontinued because of
problems related to decentration.1
The hyperopic PRL is 10.6 mm in diameter. The range
of lens power is +3 D to +15 D in half-diopter steps. Using
this lens, hyperopia of up to +11.0 can be corrected. The
optic diameter is 4.5 mm for all hyperopic PRL lenses.
Lens power calculation is based on the Russian method
of converting to the corneal plane from a vertex distance
of 12.0 mm. The PRL does not come in a toric design, and,
therefore, cannot be used to treat astigmatism. In patients
with astigmatism, the spherical equivalent is used in deter-
mining the power of the PRL to be implanted.
PREOPERATIVE CONSIDERATIONS
The range of correction of the PRL is from -23.0 D to
+11 D. Rotation is common because there is no fixation of
146 Chapter 14

Figure 14-2. Slit lamp photograph of the PRL properly posi-

Figure 14-1. Photograph of the CIBA Vision PRL. Note the
tioned. The long axis of the lens is oriented horizontally fol-
curved plate haptic design. The lens is made from a proprietary
lowing implantation through a temporal incision. Note that
soft, elastic, hydrophobic high-index silicone polymer.
the 4.5-mm optic is molded onto the anterior surface of the
6.0-mm wide haptic of this myopic PRL.

this lens, making a toric version of this lens untenable.

Patients with significant astigmatism will, therefore, not
Because of technical difficulties associated with implan-
benefit as much as those without astigmatism if PRL inser-
tation of all phakic IOLs, it is safer to implant the PRL in
tion is performed as a sole procedure. Hoyos et al1
patients with greater anterior chamber depths. Most
described success in alleviating high amounts of toric
patients receiving a PRL are high myopes with increased
refractive error by pairing PRL implantation with astig-
axial lengths; therefore, the majority have anterior cham-
matic laser in-situ keratomileusis (LASIK).
ber depths greater than average. However, high hyperopes
Aside from refractive error, eyes undergoing implanta-
will often have shorter than average eyes and shallower
tion of PRL should have no pathology. As with any patient
than normal anterior chambers. Great care must be taken
undergoing an elective refractive procedure, most clini-
in these patients when inserting a PRL to ensure that dam-
cians agree that surgery should not be recommended on
age to either the crystalline lens or corneal endothelium
patients in whom the best-corrected visual acuity of the
occurs. In order to be enrolled in the FDA Phase III trial,
fellow eye is decreased below 20/40 or so. It is recom-
patients had to have an anterior chamber depth of at least
mended that patients, especially high myopes, should
3.0 mm.
undergo a rigorous peripheral retinal examination, includ-
There is debate over the weight that pupil size should
ing scleral depression, prior to implantation of the lens.
be given when considering implantation of the PRL. The
Any suspicious retinal lesions should be treated with pho-
optic diameter for the myopic PRL ranges from 4.5 to 5.0
tocoagulation or cryotherapy prior to consideration of the
mm, and for the hyperopic PRL, it is 4.5 mm. The over-
PRL procedure.
whelming majority of articles evaluating pupil size in
Patients should not have a history of glaucoma or
refractive surgery patients have looked only at cohorts of
uveitis. They should not have a history of cataract, as there
patients undergoing LASIK or photorefractive keratecto-
is concern that any phakic IOL may lead to increased
my (PRK).3 Because of the nature of corneorefractive tech-
opacification of the crystalline lens. In addition, patients
nology, one would expect these results to be different
should not have significant iris abnormalities, such as
from those seen with phakic IOLs.
aniridia, correctropia, or angle recession.
It is conceivable that patients with high refractive
Corneal thickness and topography have no bearing on
errors, as a group, will have better results with phakic IOLs
either safety or tolerance of the PRL. In fact, phakic IOLs
than LASIK, and it is this group for which the PRL will ini-
such as the PRL are likely the safer choice for patients with
tially be recommended. Many practitioners have stopped
thin corneas or suspicious topography who desire refrac-
performing LASIK for hyperopes with more than 4 D of
tive surgery. There is a concern that these patients have a
hyperopia because of concerns with regression and post-
higher likelihood of developing corneal ectasia following
operative quality of vision. Highly myopic corrections
LASIK.2 Therefore, it may be safer to do surgery that
carry the increased risk of both ectasia secondary to exces-
spares the cornea in patients with thin corneas or topogra-
sive corneal thinning,2 and decreased quality of vision
phy consistent with forme fruste keratoconus.
from increased spherical aberration and abnormally flat

postoperative keratometry. For these reasons, it is likely
that the risk of intraocular surgery will be less than that of
corneal laser refractive procedures for patients with signif-
icantly high refractive errors.
HISTORY
The PRL has been in development since 1987. In 2000,
Dementiev et al presented their results with this lens in
Agarwal’s Refractive Surgery.4 They specifically demon-
strated their good results in implanting the PRL in Russia
and Italy over a 10-year period.
In 2002, Hoyos and coworkers reported their results
implanting the PRL in Spain between 1997 and 2000.1
Two surgeons implanted PRL in a total of 31 eyes of 17
patients. Seventeen eyes were myopic and 14 were hyper-
opic. All patients either had severe refractive errors
(greater than -15.00 or +5.00) or had thin corneas.
Minimal anterior chamber depth for inclusion was set at
2.8 mm.
Six eyes (two myopic and four hyperopic) underwent
additional, planned LASIK because of greater than 2 D of
preoperative cylinder. In these patients, the corneal flap
was created 2 weeks prior to PRL implantation. The flap
was lifted and the laser ablation was performed 1 to 2
months after implantation of the PRL.
All hyperopic eyes received the same model lens (PRL
200). This model is the one described above and has an
overall length of 10.6 mm and an optic diameter of 4.5
mm. Some myopic patients received the PRL 100 model,
which has an overall length of 10.8 mm, while others
received the PRL 101 model, which has an overall length
of 11.3 mm. Three eyes that received the PRL 100 model
lens developed visually significant decentration diagnosed
postoperatively. All three had the PRL 100 exchanged for
PRL 101 and have done well. Because of this, the PRL 100
model is no longer available, and all myopic patients
receive a PRL with an 11.3 mm overall length.
Refractive error improved considerably in this group of
patients. Using log MAR analysis, the mean preoperative
best-corrected visual acuity was 20/32. The mean postop-
erative uncorrected visual acuity was 20/39. A total of
12 eyes gained at least one line of visual acuity, and one
hyperopic eye lost one line of best-corrected visual acuity.
In the myopic group, 53% of eyes were within 0.5 D and
82% were within 1 D of the desired refraction. Of the
hyperopes, 50% were within 0.5 D, and 79% were within
1 D of emmetropia. Of the six patients who had LASIK
following PRL implantation, four were plano, one had a
spherical equivalent of -0.50, and the sixth had a spherical
equivalent of -0.75.
Complications were few and manageable. Two patients
in the hyperopic group developed pupillary block. One of
these occurred in the immediate postoperative period and
CIBA Vision Phakic Refractive Lens 147
was felt to be a result of an incomplete iridectomy. The
second occurred 1.5 years after PRL implantation. The
PRL had rotated 90 degrees and was positioned to block
the single iridectomy. The pupillary block resolved after
two peripheral iridotomies were placed using a neodymi-
um:yttrium-aluminum-garnet (Nd:YAG) laser. One hyper-
opic eye developed pigment dispersion without evidence
of elevated intraocular pressure.
One myopic patient developed steroid-induced elevat-
ed intraocular pressure that subsided after discontinuation
of topical corticosteroids. One eye developed a small ante-
rior subcapsular peripheral opacity in the crystalline lens
that was felt to be secondary to lens touch with the inser-
tion forceps during surgery. This opacity did not progress
during the ensuing 2 years. A total of four patients report-
ed an increase in halos and glare despite well-centered
lenses.
A Phase II US FDA trial evaluated 100 myopic PRLs
implanted by four surgeons. These data have not been
published in the peer-reviewed literature and will not be
discussed in detail here. However, results were similar to
those demonstrated by Hoyos and coworkers in their
work in Spain as described above.1 The Phase III US FDA
trial for this lens is currently underway.
SURGICAL TECHNIQUE
The PRL is made of a soft, foldable, silicone material
that can be implanted through a self-sealing clear corneal
incision. Although the plate haptic shape will be familiar
to many cataract/IOL surgeons, the material is much soft-
er and more pliable than that of standard silicone IOLs.
When handling this lens, the surgeon is reminded more of
a thin, disposable, soft contact lens than of a silicone IOL.
Two peripheral iridectomies (PIs) must be performed
four clock hours apart. In patients in the Spanish study
described above, only one iridectomy was made. It was felt
that the late angle closure that developed in that study
would not have occurred if two PIs had been created
instead of one. For this reason, it is recommended that all
patients receive two PIs. The PIs are positioned at the
10:00 and 2:00 positions. In this way, if the PRL rotates so
as to block one of the PIs, the other one will still be patent.
Some surgeons prefer to make these PIs using a
Nd:YAG laser. In these cases, Nd:YAG peripheral iridoto-
my should be performed at least 1 to 2 weeks prior to the
PRL implantation procedure. Other surgeons prefer to
accomplish this through a surgical peripheral iridectomy.5
In these cases, PIs should be made during the PRL implan-
tation procedure.
Implantation of the PRL should be performed under
retrobulbar anesthesia. Care must be taken in performing
retrobulbar blocks in high myopes, as many of these
patients will have axial lengths of 30 mm or more and are
148 Chapter 14
Figure 14-3. Ultrasound of the PRL positioned in the poste-
rior chamber. Note that that footplates are not anchored in
the ciliary sulcus. The lens is gently pushed anteriorly by the
natural movement of aqueous humor within the eye. The
lens optic is molded onto the anterior surface of the lens
and is centered in the pupil by natural action of the iris
sphincter.
more susceptible to posterior scleral injury from the retrob-
ulbar needle. However, because retrobulbar anesthesia pro-
vides better anesthesia, amaurosis, and akinesia, it is felt that
the benefit of retrobulbar anesthesia overrides the increased
risk.
The patient is dilated per routine cataract surgery proto-
col. After the placement of the retrobulbar block, a honan
balloon is applied at 30 mmHg, and the patient is brought
to an operating room equipped for intraocular surgery.
Standard phacoemulsification and a pseudophakic IOL
should be available in the rare situation that trauma to the
crystalline lens during PRL implantation necessitates emer-
gent cataract extraction and intraocular lens implantation.
The eye is prepped and draped using the usual sterile
fashion for intraocular surgery. A standard 3.0- to 3.5-mm
clear corneal cataract incision is created with a diamond or
metal knife, whichever the surgeon prefers. One millimeter
paracentesis port incisions are made three clock hours to the
left and right of the temporal incision. The anterior chamber
is filled with a mildly cohesive viscoelastic, such as Biolon
(Bio-Technology General Corp, East Brunswick, NJ).
The PRL is then inserted through the temporal incision
(Figure 14-3). A special injector has been developed for
this purpose (Figure 14-4). However, as of the writing of
this text, the injector has not been approved for use in the
FDA Phase III trial. Patients enrolled in the FDA Phase II
trial and those reported by Hoyos and coworkers1 had
implantation of the PRL with Dementiev forceps (Rumex
International, Miami, Fla). These forceps open in an
anteroposterior (vertical) fashion and are designed to
grasp the haptic while avoiding the optic of the PRL. It is
also designed to avoid both the crystalline lens and
corneal epithelium upon opening. Most surgeons agree
that safely and effectively inserting the PRL into the ante-
rior chamber with forceps is the most technically chal-
lenging part of the procedure. The injector should make
this aspect of the surgery significantly easier.
Once the PRL is placed into the anterior chamber, it is
important for the surgeon to ensure that it is not inverted.
Figure 14-4. The PRL injector.
Because the optic is molded onto the anterior surface of
the lens, the surgeon merely has to feel for its edge with a
spatula to ensure that the lens is positioned appropriately.
The four corners of the haptic are then merely tucked
under the iris with a Dementiev PRL spatula (Rumex
International, Miami, Fla) or similar instrument. Great care
must be taken to ensure that neither the crystalline lens
nor the corneal endothelium is damaged during surgical
manipulation.
Once all four corners of the plate haptic are tucked
under the iris, the cohesive viscoelastic is exchanged with
Miochol (CIBA Vision, Duluth, Ga), which is instilled
through a blunt-tipped cannula. Mechanical irrigation-
aspiration normally does not have to be performed. As the
pupil comes down, the surgeon must ensure that the hap-
tics stay posterior to the iris and the optic is centered in
the pupil.
The wounds are tested for water-tightness and can be
hydrated or sutured if any are found to leak. Topical antibi-
otic and corticosteroid are placed on the cornea, and the
patient is given oral acetazolamide 250 mg immediately
postoperatively. A fox shield is taped over the eye for the
first day. The patient takes a second oral acetazolamide 250
mg at bedtime and begins topical antibiotic and corticos-
teroid four times daily on the first postoperative day. The
patient is typically examined at postoperative days 1, 3, and
7, then postoperative months 1, 3, 6, and 12.
SUMMARY
The CIBA Vision PRL is proving itself a safe and effec-
tive alternative to laser vision correction. It is especially
beneficial for patients with high spherical refractive errors
or those who are not suitable candidates for keratorefrac-
tive procedures. Surgeons familiar with techniques of
cataract extraction and posterior chamber lens implanta-
tion will find most techniques associated with implanta-
tion of this lens familiar. The fact that the lens floats in the
posterior chamber makes it easier to size and will possibly
lead to less cases of IOL-induced lens opacification than
other posterior chamber phakic IOLs. However, this
aspect of the lens will hinder the likelihood that a toric
version of this lens will be developed.

As of the writing of this text, the PRL is going through
US FDA Phase III trials. It has been used in Italy, Spain,
and Russia with significant safety and efficacy.
REFERENCES
1. Hoyos JE, Dementiev DD, Cigales M. Phakic refractive lens
experience in Spain. J Cataract Refract Surg.
2002;28(11):1939-1946.
2. Randleman JB, Russell B, Ward MA. Risk factors and prog-
nosis for corneal ectasia after LASIK. Ophthalmology.
2003;110(2):267-275.
CIBA Vision Phakic Refractive Lens 149
3. Haw WW, Manche EE. Effect of preoperative pupil meas-
urements on glare, halos, and visual function after pho-
toastigmatic refractive keratectomy. J Cataract Refract Surg.
2001;27(6):907-916.
4. Dementiev DD, Hoffer KJ, Sborgia G, et al. Phakic refrac-
tive lens for correction of myopia and hyperopia. In:
Agarwal S, Agarwal A, Pallikaris IG, et al, eds. Refractive
Surgery. New Delhi: Jaypee Brothers; 2000:440-461.
5. Hoffer KJ. Pigment vacuum iridectomy for phakic refractive
lens implantation. J Cataract Refract Surg. 2001;27(8):1166-
1168.

Baïkoff’s Foldable Anterior
Chamber Phakic Intraocular Lenses
for Myopia, Hyperopia, and Presbyopia
Georges D. Baïkoff, MD
INTRODUCTION
The 1960s saw the beginning of the development of
implants for phakic eyes. The European pioneers
(Barraquer, Choyce, Stampelli, etc) suggested the use of
intraocular lenses to correct high myopia while preserving
the crystalline lens. At the same time they began to correct
aphakia with intraocular lenses (IOLs).
All of these attempts with phakic IOLs led to serious
anatomical complications, so the techniques were put
aside until 1985 to 1987 when, under the influence of
Fyodorov, Fechner, and Baïkoff, they were once again put
back on the agenda. Each surgeon developed a different
type of fixation: posterior chamber, iris fixated, and angle
supported.
Back in 1986, angle-supported anterior chamber
implants were already being developed by modifying the
characteristics of Kelman’s multiflex lens for the correction
of aphakia (Figures 15-1 to 15-4).
Between 1987 and 1989, the first trials with the ZB 5M
(Bausch & Lomb Surgical, Rochester, NY) implant gave
excellent optical results, but unfortunately, a relatively
high endothelial cell loss was noted during the first 18
months.1-11 This lead to a modification of the lens vault-
ing in order to downsize it and reduce the endothelial
damage at the time of implantation.
Starting in 1990, the ZB 5M implant and then its suc-
cessor, the NuVita implant (Bausch & Lomb Surgical,
Rochester, NY), adopted a profile that maintained a mini-
mum 1.5-mm clearance between corneal endothelium and
the lens edge for the highest powered lenses (ie, the lens-
15 Chapter
es with the thickest edges). By adhering to this secure pro-
file, no serious endothelial cell loss other than the usual
physiological loss has been observed since 1990. The only
complications related to this lens are pupillary ovalization,
most of which is due to oversizing of the lens.
These type of implants have shown that the induced
complications such as cataracts, uveitis, glaucoma, and
corneal decompensation were extremely rare.
INDICATIONS
Today, the indications are directly linked to the limits
of corneal surgery. For the time being, photorefractive ker-
atectomy (PRK) and laser in-situ keratomileusis (LASIK)
predominate the indications for refractive surgery.
However, the optical quality is less satisfactory in higher
corrections. Moreover, the scatter of the results means fre-
quent enhancements.
The creation of an interface during LASIK can bring
about a loss in contrast sensitivity that will penalize the
optical quality despite a satisfactory anatomical and topo-
graphic result. Lastly, LASIK is not without optical or
anatomical complications (eg, diplopia, loss of visual acu-
ity, loss of contrast sensitivity, epithelial ingrowth, flap
shifting, infections).
Nowadays, it can be said that the range for LASIK is
between +3 diopters (D) and -10 D. High myopes and
high hyperopes beyond these limits obtain more satisfac-
tory results with refractive implants. In his everyday prac-
tice, the author systematically proposes a refractive
implant to patients with over -10 D and for patients
152 Chapter 15

Figure 15-1. Image

of an angle-support-
ed IOL in place.

Figure 15-3. First-gen-

eration ZB implant
from 1988.

Figure 15-2. First-generation ZB implant developed in 1986/1987.

between -8 D and -10 D, he gives them the choice. Over

time, new indications have appeared and all suspect
corneas with subtle topographical abnormalities must be
eliminated because it is in this group that post-LASIK
corneal ectasia has been observed.
Therefore, the author systematically proposes today a
refractive implant if at least one of the following condi-
tions is met:
• Corneal thickness less than 500 µm
• Asymmetric astigmatism
• Irregular astigmatism
• Decentration of the corneal apex
• Forme fruste keratoconus
This means that even with a slight myopia of, for exam-
ple, -2 D, if one of the aforementioned abnormalities
exists, the author systematically suggests either a refractive
implant or nothing. While waiting for a transplant, a
refractive implant can be proposed to a patient who has
started to develop keratoconus. The quality of the correc-
tion is almost identical to that of a contact lens, which is
typically poorly tolerated on a clinical basis.
Refractive corneal surgery presents additional limits. The
author believes that it is contraindicated to suggest a PRK or
LASIK for an enhancement if, after radial keratotomy, a
decline of the effect and a return toward myopia or a hyper-
opic shift is observed. Indeed, the evolution of a refractive
disorder is proof of the instability of the cornea and today, it
seems totally illogical to further damage an unstable cornea
with a cut of which the long-term effects are still unknown.
This is why the correction of progressive refractive abnor-
malities following radial keratotomy is an excellent indica-
tion for refractive implants. Moreover, if the refractive
abnormalities continue to progress, it is relatively simple to
Figure 15-4. ZB 5M implant. It went into pro-
duction in 1990.
exchange the implant, especially as these former myopic
eyes generally have a very deep anterior chamber.
Patients suffering from dry eyes, a condition that dete-
riorates after corneal surgery, such as PRK or LASIK, are
also excellent candidates for refractive implants.
DESCRIPTION OF THE
FOLDABLE ANGLE-SUPPORTED
ANTERIOR CHAMBER PHAKIC
IMPLANT (GBR/VIVARTE)
The interest of angle-supported anterior chamber
implants is their simplicity. The lens is perfectly visible in
the anterior segment, and any abnormality is easy to visu-
alize with a slit lamp. Gonioscopy will show the effects the
footplates have on the iridocorneal angle. A correctly
designed lens does not come into contact with the
endothelium and respects the iris and the crystalline lens.
Should a problem arise, it is easy to remove or change the
lens. These angle-supported anterior chamber lenses are of
such interest that nine companies are working in that field
 Baïkoff’s Foldable Anterior Chamber Phakic Intraocular Lenses
Figure 15-5. GBR/Vivarte
implant.
(Alcon, AMO, Bausch & Lomb Surgical, CIBA Vision,
IOLTech, Morcher, O.I.I., Thinoptx, Tekia). It is perfect-
ly logical to insert an implant in the anterior chamber
because that is where the most space is available. It is
important to respect rigorous safety profiles in order to
keep away from fragile structures, such as the corneal
endothelium.
Today, anterior chamber implants with safe designs no
longer cause anterior segment complications (ie, corneal
decompensation, cataract, glaucoma, uveitis). The only
problem noted is a small number of pupillary ovalizations
often due to oversizing of the implant. It is, therefore,
imperative to evaluate the diameter of the anterior seg-
ment before choosing the implant and to use implants with
well-designed footplates.
It is also important to have a stable implant in the ante-
rior chamber to avoid the problem of unwanted lens
mobility and energy dispersion as was observed with
Binkhorst 4 loops implants inserted after intracapsular
cataract extraction (ICCE). It is, therefore, necessary to
have a sufficiently rigid stable haptic with a soft optic as
the risk with a soft haptic is an unstable lens.
The profile of the GBR/Vivarte lens (IOLTechnologie,
La Rochelle, France/CIBA Vision, Duluth, Ga) was
designed to combine a stable haptic made of a material
such as polymethylmethacrylate (PMMA) together with a
soft optic made of an acrylic type of material (Figure 15-
5). The approximate “2” shape of the haptic and the three
footplates enable the haptic to be inserted easily into the
anterior chamber without having to twist or manipulate it
in a complicated way. If a Kelman-type implant with four
support points had been chosen, there would have been
difficulties during the unfolding of the haptic in the ante-
rior chamber. The optic of the GBR/Vivarte lens is round
with a 5.5-mm diameter, which makes it possible to rea-
sonably reduce halos and edge effects. Concerning high
ametropias, there is no technique (PRK, LASIK, or
153
Figure 15-6. Measure of the anterior chamber diameter
with the plastic sizer.
implants) that will completely eliminate nocturnal halos
no matter what the diameter of the pupil. This is only rel-
atively important, as most high myopes normally suffered
from nocturnal vision discomfort before surgery whether
they wore glasses or contact lenses.
MEASUREMENT OF THE
INTERNAL DIAMETER
OF THE A NTERIOR C HAMBER
An angle-supported anterior chamber implant will be
successfully tolerated if it is correctly adapted to the diam-
eter of the anterior chamber. Up until now, the techniques
for evaluating the diameter of the anterior chamber were
based on indirect evaluations of the outside aspect of the
ocular structures: white-to-white measurement with a
compass, a photographic white-to-white evaluation, etc.
These measures were only approximate and required
adding an adaptation factor that was different from one
surgeon to the other or even from one eye to the next.
Therefore, we had the opportunity to evaluate different
techniques that will likely evolve over the next few months
or years.
• Measurement with a plastic sizer at the time of sur-
gery
• Preoperative automatic optical measurement based
on optical or ultrasonic principles
Manual Sizer
The manual sizer is a small plastic ruler that is inserted
into the anterior chamber to measure the internal diameter
(Figure 15-6). The tip rests on the angle opposite the inci-
sion, and the graduations in the middle of this ruler allow an
154 Chapter 15
Figure 15-7. Evaluation of white-to-white diameter meas-
ured with topography.
estimate of their projection on the center of the anterior seg-
ment. The author tried to mark the corneal center and study
its projection on the center of the ruler, but the mark was
very approximate and the estimate subject to parallax errors.
The constant anatomic reference nearest to the anatomical
center of the anterior segment seems to be the middle of the
temporal margin of the pupil. Indeed, the pupil is practically
always decentered toward the nose, and the temporal edge is
the fixed point nearest to the geometric center of the cornea.
The plastic sizer must be used according to the vertical
meridian, 6:00 to 12:00, because the pupil is centered on this
meridian; however, on the horizontal meridian, the pupil is
decentered toward the nose, which means that the sizer must
not be used on the 3:00 to 9:00 axis.
The plastic sizer is inserted at the beginning of surgery
with regards to the vertical meridian in an anterior cham-
ber reformed with viscoelastic. The extremity of the sizer
is pushed into the inferior angle without applying too
much pressure, which would falsely elongate the measure-
ment and lead to insertion of a lens that is too long. This
would cause the iridocorneal angle to move backward and
create pupillary ovalization. It is important to check that
the pupil remains perfectly round at that moment. The iris
plane must be perpendicular to the microscope’s axis to
reduce parallax errors. Finally, the graduations are read
opposite the center of the pupil’s temporal edge. If in
doubt, it is preferable to choose the smaller size to avoid
oversizing of the lens, leading to pupillary ovalization.
This technique has the disadvantage of being done
intraoperatively and means that the surgeon must have at
his or her disposal several lenses of identical power but of
different diameters. It is, therefore, of the utmost impor-
tance to focus on a preoperative measuring technique for
Figure 15-8. Evaluation
of internal diameter of
the anterior chamber
with the IOLTech LED
sizer.
choosing the right lens while avoiding stocks of lenses that
are difficult to manage.
Use of Preoperative Photos of the
Anterior Segment With Topographs
Corneal topographs give calibrated photos of the ante-
rior segment. With a bit of experience, it is possible to
have a correct measurement of the internal horizontal
anterior chamber diameter by taking into consideration
the distance between the external limits of the limbic ves-
sels from their nasal side to their temporal side rather than
clear cornea to clear cornea. The projection of the exter-
nal border of the limbic arch corresponds more or less to
the sinus of the iridocorneal angle. In general, three meas-
urements are taken according to the corneal diameter
apparent in the pupillary area horizontally and slightly
oblique. The average of these three measurements gives us
an evaluation very close to the internal diameter of the
anterior chamber. As the implants are available on a scale
that is in 0.5-mm increments, the implant with the nearest
corresponding diameter will be used. For instance, in
Figure 15-7, the implant chosen will be one with a 12-mm
diameter for a diameter of 11.9 mm.
The LED Sizer
The light emitting diode (LED) sizer (IOLTech)
retroilluminates the anterior segment. If the anterior seg-
ment is illuminated laterally, the cornea is totally transpar-
ent, the sclera behind the uveal tissue insertion is opaque,
and the corneoscleral junction is translucent (Figure 15-8).
A laterally illuminating probe is applied against the eye
and the anterior segment is photographed. The image is
interpreted by a computer that analyzes different diame-
ters at the junction between the translucent zone and the
opaque zone. Theoretically, this opaque-translucent junc-
tion is the exact projection of the angular sinus as it corre-
sponds to the adhesion of the iris root to the sclera.
This process is actually under development and should
be available within the next few months.
 Baïkoff’s Foldable Anterior Chamber Phakic Intraocular Lenses
Figure 15-9. Profile of a presbyopic implant on a phakic eye
(UBM Artemis Ultralink).
Ultra-High Frequency Scanner Study
Ultra-high frequency scanners (over 50 MHz) give a
very good quality image of the anterior chamber. One of
the leaders in this new generation of machines is the
Artemis Ultralink (Ultralink LLC, St. Petersburg, Fla),
which the author has been able to use. The process of test-
ing is fairly lengthy and the scan is done directly through
a water bath. The images are of excellent quality, but to
date, the program does not yet allow for a choice in
corneal diameter. We are still at the point where the esti-
mation of the largest diameter is left to the subjectivity of
the surgeon.
The advantages over the previous generation of ultra-
sound biomicroscopy units is the capacity to produce a
one-shot image of the anterior chamber, thus avoiding
errors due to reconstructing an image from several differ-
ent shots. It is, therefore, very easy to evaluate the differ-
ent biometric data of the anterior segment: AC depth,
corneal thickness, distance of the implant from the cornea,
safety distance between the edge of the implant and the
endothelium and to answer the question—internal diame-
ter of the anterior chamber in vivo and preoperatively.
The equipment is not yet routinely available but should
appear on the market within the next few months (Figure
15-9). The disadvantages of the equipment are mainly its
size, the length of time needed for an examination, and the
existence of a double water chamber in front of the cornea,
making it necessary to balance the pressure of the water
bath and the anterior chamber (as too much pressure in
the water bath would crush the anterior chamber and
modify its biometric data).
Optical Coherence Tomograph Scanner
The last device that might be the most promising is the
Anterior Chamber Optical Coherence Tomograph
Scanner (AC OCT, Zeiss Humphrey) (Figure 15-10).
This technique is derived from the optical coherence
tomograph scanner developed for the posterior segment.
A different wavelength is required, which means that the
equipment for the posterior segment cannot be used for
the anterior segment. With this technique, it is possible to
155
Figure 15-10. Profile of anterior segment measured with
the AC OCT (courtesy of Carl Zeiss Meditec).
rapidly obtain an optical cut of the anterior segment with-
out any contact, which avoids pressure and modifications
of the biometric settings. It is still necessary to define cor-
relation factors to improve the measurements and it is not
always possible to visualize the ciliary body and the sulcus.
However, in eyes with widely dilated irises, the images of
the crystalline lens and the sulcus are better. Because of its
simplicity, rapidity, and precision, this technique will cer-
tainly establish its supremacy as far as anterior chamber
implants are concerned. The image definition is of excel-
lent quality, and different factors or different biometrics
data will be rapidly defined.
ANESTHESIA AND
SURGICAL TECHNIQUE
The surgeon and the patient can choose the type of
anaesthesia: general, local/regional, or topical. The tech-
nique of topical anesthesia is perfectly feasible, as it is
rapid and painless.
A miotic will be instilled preoperatively in order to pro-
tect the crystalline lens during surgery.
Incision
The first step is a corneal or corneoscleral incision. It can
be done either on the vertical meridian, on the horizontal
meridian, or on any other meridian in order to gently con-
trol any astigmatism. The less astigmatism-inducing incision
is a posterior corneoscleral one on the temporal meridian
(Figure 15-11A). If the incision is more anterior in clear
cornea, then the astigmatic effect will be greater than a pos-
terior corneoscleral incision. As the size of the incision is
moderate, the effect on astigmatism will still typically be
limited to between 0.5 and 1 D. Depending on where the
incision is made, astigmatism is typically less than 1 D.
Steel or diamond blades can be used; the dimension of
the incision for a high myopic eye is at most 3.2 mm,
which allows insertion of the implant in a folded configu-
ration. For a presbyopic implant, which is very thin, a 2.8-
mm to 3-mm incision is sufficient.
156 Chapter 15
A B
C D
Figure 15-11. A. 3-mm corneal incision. B. Injection of
viscous substance in the anterior chamber. C. Insertion of
a soft implant in the anterior chamber. D. End of surgery
aspect.
Viscoelastic
After a corneal incision, the anterior chamber is filled
with a viscoelastic substance. Depending on habit, either a
regular or a high viscous substance can be used (Figure 15-
11B).
Paracentesis
Two paracenteses are done on the axis perpendicular to
the main incision. These paracenteses allow the implant to
be manipulated at the end of surgery. We believe that they
should be done systematically. Indeed, it is preferable to
have two paracenteses that will not be needed rather than
doing one at the end of surgery, which will be more diffi-
cult, when the eye has become soft.
Checking the Diameter
of the Anterior Chamber
This is done as described previously.
Folding the Implant
It is important to follow folding instructions because
the simplicity of surgery depends on the quality of the
folding. Folding is basically the only part that requires a
little training beforehand. A folder and a pair of holding
forceps were specially designed for the implant. The fold-
ing forceps are a sort of press in which the implant is
placed. When the jaws of the press are closed, the optical
part is folded into three parts, which allows it to be
grasped by the inserting forceps. The operator has to get
used to coordinating the opening of the press with the
closing of the insertion forceps. Pressure on the folder is
gently released and the optic is firmly grasped with the
forceps. Theoretically, the optic folded into three can be
grasped, while the haptics remain free.
Inserting Into the Anterior Chamber
The knee of the inferior haptic (double haptic) is insert-
ed first, then guided through the anterior chamber hori-
zontally in front of the pupil (Figure 15-11C). Once the
optic is correctly positioned in the anterior chamber, pres-
sure on the optical part is released. The optic will unfold
gently and the forceps are removed. If necessary, vis-
coelastic can be reinjected. Finally, the trailing haptic is
gently pushed inside the anterior chamber.
Repositioning of the Haptics
At the end of surgery, it is very important to reposition
the lower footplates by using the lateral paracentesis. The
footplates are lifted forward slightly with a foam rubber
hook (Leister type). This avoids iris tucking and reduces
the risk of iris distortion. When the implant is correctly
positioned, the roundness of the pupil must be checked
and, if necessary, the correct positioning of the footplates
can be verified with a gonioscope.
Viscoelastic Removal
At the end of surgery, it is essential that all viscoelastic
be removed either with a simple cannula or with a system
of irrigation/aspiration. The anterior chamber is refilled
with balanced salt solution (BSS), and the water-tightness
of the incisions is verified. If the incisions were not per-
fectly water-tight, saline can be injected into the corneal
incision stroma to help sealing or else a 10-0 nylon suture
can be placed (Figure 15-11D).
Iridectomy Problems
With angle-supported anterior chamber implants like
the NuVita or Vivarte/GBR, it is not necessary to perform
an iridectomy because the vaulting is sufficient to avoid a
pupillary block. However, if the surgeon wishes to carry
out an iridectomy or an iridotomy, it can be done either by
laser before or after surgery or during surgery using a sur-
gical procedure. It is preferable to avoid an iridectomy that
is too basal because if the implant’s footplates rotate, they
could go through the iridectomy and come into contact
with the zonules or the crystalline lens.
Postoperative Care
Immediately following surgery, acetazolamide adminis-
tered intravenously is recommended to reduce the risk of
ocular hypertension and a tablet of acetazolamide is pre-
scribed that same evening. By taking these precautions, in
the author’s experience, no postoperative Urrets-Zavalla
syndrome have been observed over the last 15 years.
 Baïkoff’s Foldable Anterior Chamber Phakic Intraocular Lenses
Figure 15-12. GBR/Vivarte implant in place
(courtesy of Norma Allemann).
Antibiotic steroid eye drops are given for 1 month.
Refraction is checked the first day after surgery. In the case
of over- or undersizing or an error in the power of the lens,
the implant can be exchanged quite rapidly.
Bioptics
The bioptics technique (LASIK flap + refractive phakic
implant) is interesting where the optical characteristics of
the implant cannot correct ametropia (eg, in the case of
astigmatism or an optical spherical power not available in
the desired implant range).
With the Vivarte/GBR, the LASIK flap is done immedi-
ately before opening the anterior chamber by using either
a superior or nasal hinge. The IOL surgery is undertaken
in the same manner as in cases not utilizing bioptics.
RESULTS IN MYOPIC PATIENTS
Indications
Myopia was the first indication for refractive implants.
Unfortunately, the Vivarte/GBR implant is only available
today for the correction of myopia or presbyopia. The
manufacturers have not made a simple or toric hyperopic
implant, although this type of implant could be used in a
great number of cases.
The lens is available between -7 D and -20 D and takes
into account the depth of the anterior chamber according
to the different powers. Between -7 D and -13 D the ante-
rior chamber depth must be equal to or more than 3.2 mm.
Between -13 D and -18 D, the depth must be equal to or
more than 3.4 mm, and above -18D it must be equal to or
more than 3.6 mm. This restriction criteria excludes only a
small number of patients and if the anterior chamber is not
sufficiently deep, the Vivarte/GBR implant can be com-
bined with a LASIK flap to correct astigmatism or residual
ametropia.
157
Contraindications
The implant is contraindicated in the case of anterior
segment pathologies and, in particular, endothelial abnor-
malities. Uveitis, cataract, synechia, neovascularization,
and glaucoma are also contraindications. However, it is
much better to propose a refractive implant to a patient
with slight ocular hypertension rather than LASIK;
indeed, LASIK will lower the intraocular pressure meas-
ured with applanation on a reshaped cornea and it will be
difficult to know which baseline value to use for the
tononometric follow-up of that patient. On the other
hand, with a refractive implant, the measuring method is
not modified and the risk of glaucoma is extremely low
except in the case of postoperative steroid-induced hyper-
tension.
Clinical Results
Clinical results with regards to myopic implants are
excellent and are similar to those obtained with all other
type of refractive implants (Figure 15-12).1,2,5-7,10-12
FOLDABLE PRESBYOPIC PHAKIC
INTRAOCULAR LENS (VIVARTE,
PRESBYOPIC, GBR NEWLIFE)
Concept
Using a presbyopic phakic implant is an extrapolation
from pseudophakic multifocal implants. After placing a
multifocal implant for cataract surgery, good results can be
obtained (in 70% of cases) if the patient is emmetropic and
without astigmatism. If the patient is ametropic or has
residual astigmatism, the success rate falls to 30%.
A former study was carried out with Professor Eva
Volkova in BRNO, Czech Republic that allowed us to estab-
lish the feasibility of the concept with emmetropes. The trial
was then extended to cover ametropic patients, and an offi-
cial study was undertaken in France under the “Huriet Law.”
Equipment and Methods
The lens used had the same optics as the Vivarte or the
GBR (PMMA - tripod) (Figure 15-13). The optical part is
made of hydrophilic acrylic and divided into three zones:
central zone for distant vision, intermediate zone for near
vision, and peripheral zone for distant vision. The lens
was, therefore, simply a bifocal one. Optical power avail-
able for distance vision is between -5 D and +5 D.
Addition for near vision is +2.5 D, which is a compromise,
allowing the correction of patients between the ages of 50
and 60. The 50-year-old patient is slightly overcorrected
and the 60-year-old patient is slightly undercorrected.
158 Chapter 15

Figure 15-13. GBR/Vivarte

presbyopic implant.
Results
Forty eyes of 25 patients were operated on between
August 2000 and December 2002. Ages were between 45
and 70 years. There were 16 women and 9 men.
Preoperative refraction was between -5 D and +5 D. Some
patients had LASIK beforehand to correct astigmatism or
an associated ametropia. One patient had radial keratoto-
my. There were five myopic eyes and 35 hyperopic or
emmetropic eyes. The results were excellent, with 75%
obtaining a postoperative visual acuity above 20/30 and
seeing J1/J2 without correction.
One patient suffered loss of visual acuity of greater than
two lines between 3 and 4 months postoperatively. Visual

Table 15-1

COMPARISON OF HYPEROPIC AND MYOPIC EYES

Hyperopic Group Myopic Group
Number of Eyes 35 5
Number of Patients 21 4
Mean Follow-Up 35 weeks (10 to 62) 47 weeks (39 to 49)

Preoperative Postoperative Preoperative Postoperative

Mean Refraction (SE) (D) +1.75 -0.14 -1.9 -0.35
Mean Cylinder (D) -0.17 -0.44 +0.37 -0.66
Percentage of Eyes Within 34% 91% 20% 80%
± 1 D of Emmetropia
Mean UCVA (distant) 0.47 0.8 0.31 0.72
Mean BCVA (distant) 1 0.95 0.98 1
Mean UCVA (near) Parinaud 16 2.2 5 2.2
Mean BCVA (near) Parinaud 2 2 2 2
Average Endothelial Cell Count 2613 2455 2537 2463

Indications fields, fluorescein angiography, and OCT showed no

The eye must be normal, with an anterior chamber
depth above 3.1 mm (calculated from the surface of the
corneal epithelium to the anterior face of the crystalline
lens) and the angle must be open. The minimum required
endothelial density is equal to or above 2000 cells/mm².
There must be no associated anterior segment pathology.
The optical power of the implant is calculated according
to Holladay’s formula.
Surgical Technique
The surgical technique is the same as the one described
earlier.
anomalies. After 3 or 4 months, visual acuity was restored.
Four eyes had complementary LASIK or PRK to treat
residual ametropia. Visual results are shown in Table 15-1.
It must be noted that preoperative mean refraction is
slightly hyperopic and that the postoperative results are
slightly myopic. Preoperative uncorrected visual acuity
(UCVA) is 20/40 and postoperative UCVA is 20/25. The
technique gives a refractive result comparable to other
refractive surgery techniques.
Preoperative best-corrected visual acuity (BCVA) is
20/20; this drops slightly postoperatively due to a loss of
contrast sensitivity. Near BCVA is J1/J2 preoperatively,
near postoperative UCVA is more or less the same.
 Baïkoff’s Foldable Anterior Chamber Phakic Intraocular Lenses
Three implants were exchanged due to power or sizing
errors. No particular problems were encountered.
Postoperative Outcome
LASIK or PRK Enhancement
In four eyes, it was necessary to carry out an enhance-
ment with PRK or LASIK to improve visual acuity.
Removals
Two lenses were removed due to unsatisfactory results.
In one case, the patient had an uncomfortable intermedi-
ate distance visual acuity; in the other case, there was a
reduction in near and distance visual acuity.
Pupillary Ovalization
Five cases of moderate pupillary ovalization were
observed along with synechiae in the angle.
Halos
Four patients out of 25 complained of halos. However,
these halos did not prevent night driving even if driving
was not as fast as before.
Cataracts, Glaucoma, and Corneal Edema
In this series, no cataract, definitive ocular hyperten-
sion, or corneal decompensation was observed.
Corneal Endothelium
After 1 year follow-up, endothelial cell loss was
between 3% and 6%, which is normal following refractive
implant surgery (Table 15-2).
An important loss was observed postoperatively in one
patient because only central endothelial cell density was
measured. After several months, the endothelial cell densi-
ty of these patients returned to normal. It is, therefore, a
159
Table 15-2. Endothelial cell loss observed at
9-months follow-up in hyperopic patients
with presbyopic implants.
central intraoperative trauma, which explains the impor-
tant loss measured at the beginning, cells from the periph-
ery slowly replace cells lost in the center.
Loss of Visual Acuity
An average loss of visual acuity of less than one line was
observed. This corresponds to a decrease in contrast sen-
sitivity, which is easy to understand with a multifocal
implant. It must be remembered that multifocality reduces
light reaching the retina and this is not as accepted with
older patients because with age there is a physiological
reduction of retinal illumination due to a natural loss of
crystalline lens transparency and a reduction of the pupil
diameter.
It is, therefore, important to be very careful with
patients over 60 to 65 years of age who show the begin-
ning of crystalline lens opacity.
CONCLUSIONS
The results of presbyopic phakic implants are satisfac-
tory on the condition that the following contraindications
are taken into account:
• Shallow anterior chamber, below 3.1 mm; rarefied
endothelium below 2000 cells/mm², anterior seg-
ment pathology, anomalies of the posterior pole
• Patients that are too “critical”
• Finally, because of the risk of nocturnal halos, it is
preferable not to do surgery on patients having to
drive at night for professional reasons, such as taxi
drivers
The results are very good in situations in which the
patient is warned that it is an alternative to presbyopic sur-
gery that use of a multifocal implant on a phakic eye is a
compromise between an excellent preoperative vision and
160 Chapter 15
a good postoperative vision. If the patient is too demand-
ing and wishes the same vision after surgery, it is necessary
to persuade him or her against this sort of device.
To conclude, this first series of phakic implants to cor-
rect presbyopia shows that the technique is effective and
that it is reversible because the implant can be removed if
an error has been made or if the patient is not satisfied. In
the future, it can be hoped that optical engineering will be
able to produce better quality optics and that we can per-
haps adjust or exchange the implants used today. In some
cases, unilateral correction was well tolerated if the domi-
nant eye of the emmetropic patient is operated on. With
an ametropic patient, it is necessary to treat the ani-
sometropia by operating on the second eye using either a
conventional refractive surgery technique or with a pres-
byopic implant adapted to his or her refraction.
REFERENCES
1. Baïkoff G, Arne JL, Bokobza Y, et al. Angle-fixated anterior
chamber phakic intraocular lens for myopia of -7 to -19
diopters. J Refract Surg. 1998;14(3):282-293.
2. Baïkoff G. Phakic anterior chamber intraocular lenses. Int
Ophthalmol Clin. 1991;7:277-281.
3. Mimouni F, Colin J, Koffi V, Bonnet P. Damage to the
corneal endothelium from anterior chamber intraocular
lenses in phakic myopic eyes. Refract Corneal Surg. 1991;
7:277-281.
4. Saragoussi JJ, Cotinat J, Renard G, Savoldelli M, Abenhaim
A, Pouliquen Y. Damage to the corneal endothelium by
minus power anterior chamber intraocular lenses. Refract
Corneal Surg. 1991;7:282-285.
5. Baïkoff G, Colin J. Intraocular lenses in phakic patients.
Ophthalmol Clin North Am. 1992;5:789-795.
6. Werblin TP. The long-term endothelial cell loss following
phacoemulsification. Refract Corneal Surgery. 1993;9:29-
35.
7. Baïkoff G, Samaha A. Phakic intraocular lenses. In: Azar D,
ed. Refractive Surgery. Stamford, Conn: Appleton & Lange;
1997:545-560.
8. Baïkoff G. Refractive phakic intraocular lenses. In: Elander
R, Rich L, Robin J, et al, eds. Principles & Practice of
Refractive Surgery. Philadelphia, Pa: WB Saunders &
Company; 1997:435-447.
9. Baïkoff G. Phakic myopic intraocular lenses. In: Serdarevic
O, ed. Refractive Surgery—Current Techniques &
Management. New York, NY: Igaku-Shoin; 1997:165-173.
10. Baïkoff G, David J. Phakic intraocular lenses. In: Azar D, ed.
Intraocular Lenses in Cataract & Refractive Surgery.
Philadelphia, Pa: WB Saunders; 2001:245-255.
11. Baïkoff G. Phakic anterior chamber lenses. In: Gimbel H,
ed. Refractive Surgery: A Manual of Principles and Practice.
Thorofare, NJ: SLACK Incorporated; 2000:218-229.

Angle-Supported Phakic
Intraocular Lenses: The Phakic 6H2
Sujata S. Purohit, MD; Raymund T. Angeles, MD; Alan C. Westeren, MD;
Jay McDonald, MD; Daniel B. Tran, MD; Tom Clinch, MD; and David J. Schanzlin, MD
This publication was supported in part by an unre-
stricted research grant from Research to Prevent Blindness,
New York, NY.
INTRODUCTION
The Phakic 6H2 (Ophthalmic Innovations
International, Ontario, Canada) is the most recent phakic
intraocular lens (IOL) designed for the treatment of mod-
erate to high myopia. The Phakic 6H2 lens has evolved
from the anterior chamber lenses pioneered by
Strampelli,1 Barraquer,2,3 and Choyce4-7 for the treatment
of aphakic refractive error, and further refined by the stud-
ies of Fechner,8,9 Praeger,10 Baïkoff,11-14 and Kelman1 for
the treatment of phakic refractive error.
The evolution of phakic myopic IOL design over the last
several decades has led to the unique Phakic 6H2 lens. The
unique features of the Phakic 6H2 lens include a large 6.0-
mm optic diameter; optic edge thinning to increase corneal
clearance; a forward convex anterior lens face that has an
antireflective coating; and advanced footplate and angular
support features that minimize iris capture, iris irritation,
and compression of the anterior chamber angle.15 The lens-
es are also coated with heparin to reduce inflammation.
In this chapter, we report the initial experience with the
Phakic 6H2 lens in the United States. These cases are part
of the ongoing US Food and Drug Administration (FDA)
clinical trial that was initiated in 2001 to test the safety and
efficacy of this lens for the treatment of myopia. This mul-
ticenter trial was conducted at four clinical sites and
includes 6-month data from 28 patients.
16 Chapter
PATIENTS AND METHODS
Patients were enrolled at four clinical sites according to a
prospective protocol. The multicenter trial was developed
utilizing the guidelines recommended by US FDA for the
investigation of new anterior chamber IOL implants. All
investigational sites obtained Institutional Review Board
(IRB) approval for the study, and all patients gave informed
consent. The investigators for this initial series of patients
included Jay McDonald, MD (Fayetteville, Alaska); Daniel
Tran, MD (Irvine, Calif); Tom Clinch, MD (Washington,
DC); and David J. Schanzlin, MD (San Diego, Calif). The
aim of the study was to show that correction of myopia
(-4.0 diopters [D] to -20 D with up to 3.0 D of astigmatism)
in human phakic eyes with the Phakic 6H2 heparinized
anterior chamber IOL is safe and effective.
INCLUSION CRITERIA
To be enrolled in the study, subjects had to be adults
between the ages of 21 to 55 years old, with myopia rang-
ing from -4 to -20 D and less than 3 D of astigmatism. A
stable correction (within 0.5 D by mean refractive spheri-
cal equivalent [MRSE]) was needed for at least 12 months
prior to surgery. Soft contact lens wearers stopped wearing
lenses 2 to 3 days prior to initial refraction, while hard or
gas permeable lens wearers stopped at least 2 weeks prior
to refraction. The spherical manifest and spherical cyclo-
plegic refractions differed by no more than 0.75 D.
Subjects needed to have two normal, healthy eyes with
best spectacle-corrected vision of 20/40 or better. The
164 Chapter 16
patient’s anterior chamber depth had to be sufficient to
accommodate the IOL, which in general meant that the
anterior chamber depth needed to be greater than 2.9 mm.
The patient’s white-to-white limbal dimensions needed to
be between 11.0 and 13.0 mm. Patients could not have a
history of previous intraocular surgical procedures.
Patients between the ages of 21 and 45 had to have central
endothelial cell count densities of at least 2500 cells/mm2,
while patients over 45 had had to have a minimum central
endothelial cell count density of 2000 cells/mm2. All
patients had to agree to participate in the study and sign
the IRB-approved Phakic 6H2 informed consent form.
EXCLUSION CRITERIA
Patients could not have prior intraocular or corneal sur-
gery in the study eye. Patients with retinal vascular dis-
ease, hypercoagulability, autoimmune disease, connective
tissue disease, diabetes, or an immunocompromised state
were also excluded. Pregnant or nursing women were
excluded from the study. Patients using ocular medications
other than artificial tears or patients using systemic med-
ications with known ocular side effects were also excluded
from entry into the study.
DETERMINATION OF
ANTERIOR CHAMBER LENS POWER
The Phakic 6H2 lens power was calculated using the
formula reported by Holladay.16 The formula is for deter-
mination of intraocular refractive implant power equiva-
lent to the patient’s spectacle correction. The calculation
for emmetropia can be altered to achieve any postopera-
tive refraction. A series of tables that assist in these calcu-
lations may be obtained from the lens manufacturer.15
Definition of Variables:
Diol = Refractive power of IOL (D)
b = Distance between IOL and cornea (mm)
Dc = Refractive power of cornea (D)
a = Distance between cornea and spectacle lens (mm)
Ds = Refractive power of spectacle (D)
Diol =
1336 – 1336
[-b + (1336/[Dc + 1000/(-a +1000/Ds)] (-b + 1336/Dc)
SURGICAL PROCEDURE
One week prior to surgery, one or two laser iridotomies
were performed. Preoperative measures also included
administration of 4% pilocarpine drops to the operative
eye 30 and 15 minutes prior to surgery. Topical anesthesia
was the preferred method, but in select cases a peribulbar
injection was used. Patients were prepped and draped in
the usual sterile manner for ocular surgery and a lid specu-
lum was introduced. A 7-mm corneal incision site was
measured with a caliper and marked. Most cases had a
clear corneal temporal incision. A paracentesis port was
created 90 degrees from the incision site. Miochol was
injected to bring down the pupil, and a small amount of
viscoelastic was injected to maintain a stable anterior
chamber throughout the surgical procedure. Care was
taken not to overfill the anterior chamber nor to inject vis-
coelastic behind the iris. A self-sealing 7-mm corneal inci-
sion was made 0.5 mm inside the limbal margin. A 7-mm
lens glide was then introduced with care to avoid contact
between the lens glide, iris, endothelium, and crystalline
lens. The lens was then introduced into the anterior cham-
ber, using the lens glide as the path for insertion until the
full optic was inside the anterior chamber and only the
trailing haptic protruded from the incision. Then, the lens
glide was gently withdrawn from the anterior chamber
using viscoelastic to maintain the anterior chamber. The
trailing haptic was then positioned into the angle beneath
the corneal shelf using a tapered “pusher.” If an iris tuck
was suspected, the angle was inspected using a Thorpe
gonioprism (Ocular Instruments Inc, Bellevue, Wash). The
incision site was closed with either a 10-0 nylon continu-
ous or interrupted suture(s), and the suture knots were
buried. Finally, continuous irrigation was applied to
remove the viscoelastic. An antibiotic-steroid drop was
applied to the eye at the close of the procedure, and then
the speculum was removed. A clear shield was placed over
the eye and was worn at bedtime for 1 week.15
POSTOPERATIVE PROTOCOL
Patients were examined on day 1, day 7, day 14, month
1, month 3, month 6, month 12, and month 24 according
to the protocol (Figures 16-1 and 16-2). At each visit, an
eye examination and visual testing were performed.
Topical corticosteroid and antibiotic drops were contin-
ued for the first postoperative week. The intraocular pres-
sure was monitored closely, and significant rises in pres-
sure were treated with ocular antihypertensive agents. The
nylon sutures were removed 2 to 6 weeks postoperatively
if they induced postoperative astigmatism.
RESULTS
Demographics
Twenty-eight subjects were enrolled at all four sites as
of December 2002, with 21 (75%) female and 7 (25%)
male. The majority of patients were Caucasian (67.9%).
The right and left eyes were operated on with equal fre-
quency. The age range was 24 to 55 years (mean = 39.3
years) (Table 16-1).
 Angle-Supported Phakic Intraocular Lenses: The Phakic 6H2 165

Figure 16-1. The Phakic Figure 16-2. Intraocu-

6H2 IOL. lar placement of the
Phakic 6H2 lens.

Table 16-1

PHAKIC 6H2 DEMOGRAPHICS

N = 28

Gender Number Percent

Female 21 75
Male 7 25

Race
Caucasian 19 67.9
Other 3 10.6
African American 1 3.6
Asian 4 14.3
DNA 1 3.6

Eye
Right 14 50
Left 14 50

Age (in years)

Average 39.3
Standard deviation 8.9
Minimum 24
Maximum 55

Contact Lens History

None 5 17.9
Soft 17 60.6
Rigid gas permeable 5 17.9
Polymethylmethacrylate 1 3.6
166 Chapter 16

Table 16-2

SUMMARY OF KEY PARAMETERS AS A

FUNCTION OF POSTOPERATIVE TIME-EFFICACY VARIABLES
1 Month 3 Months 6 Months
N = 24 n = 24 N = 22 n = 22 N = 16 n=16

UCVA 20/20 or better 3/24 12.50% 6/22 27.27% 3/16 18.8%

UCVA 20/25 or better 8/24 33.33% 8/22 36.36% 6/16 37.5%
UCVA 20/32 or better 14/24 58.33% 18/22 81.82% 12/16 75.0%
UCVA 20/40 or better 16/24 66.66% 18/22 81.82 14/16 87.5%
N = 24 N = 24 N = 22 N = 22 N = 16 N = 16
Sphere ±0.50 D 14/24 58.33% 14/22 63.64% 12/16 75.0%
Sphere ±1.00 D 20/24 83.33% 17/22 77.27% 14/16 87.5%

MRSE ±0.50 D 9/24 37.5% 13/22 59.1% 12/16 75.0%

MRSE ±1.00 D 18/24 75.0% 19/22 86.36% 15/16 93.8%
Safety Variables N=24 N=22 N=16
Loss of > two lines BCVA 0 0 0
Loss of two lines BCVA 1 0 0
BCVA worse than 20/40 0 0 0
Increase >2 D cylinder 0 0 0
BCVA 20/20 preoperatively N = 14 N = 12 N = 10
BCVA worse than 20/25 if 1 0 0
20/20 or better preoperatively

Visual Acuity Outcomes Maintenance or Loss of Best

At 1 month, 66.7% of patients (16/24) had an uncor-
rected visual acuity (UCVA) of 20/40 or better. At month
3, 82% of patients maintained 20/40 or better (18/22). At
the 6-month visit, 87.5% (14/16) maintained 20/40 or bet-
ter unaided visual acuity. This is above the specified effi-
cacy endpoint of 85% for postoperative UCVA for this
study. At month 1, 12.5% (3/24) of patients were at 20/20.
At month 3, 36.4% (6/22) of patients were at 20/20, while
at month 6, 18.8% were at 20/20 (3/16) (Table 16-2).
At month 1, 37.5% of patients had a MRSE
0.50 D
that increased to 59.1% (13/22) at month 3 and finally to
75.0% (12/16) at month 6. Overall, 93.8% of patients
(15/16) had a MRSE
-1 D at month 6 (see Table 16-2).
These results are also above the specified efficacy end-
point for this criteria (75% of patients have MRSE
1.00
D of intended correction and 50% of patients have MRSE

0.5 D of intended correction) (see Table 16-2).
Spectacle-Corrected Visual Acuity
In terms of safety, no patient lost >2 lines of best spec-
tacle-corrected visual acuity (BSCVA). In addition, no
patient had BSCVA worse than 20/40 or had >2 D of
increased cylinder (see Table 16-2). Safety endpoints
specified in this study for loss of BSCVA <2 lines should
be less than 5%, BSCVA worse than 20/40 was not to
exceed 1%, and increased cylinder of >2 D should be less
than 1%.
Best-corrected visual acuity (BCVA) for distance
showed 41.7% (10/24) of patients at month 1 to have
20/20 acuity. Fifty-nine percent (13/22) of patients at
month 3 had 20/20 acuity, and finally 50% (8/16) main-
tained 20/20 visual acuity (Table 16-3).
One patient exhibited raised intraocular pressure imme-
diately postoperatively that was not seen at the 3 or 6
month visit. No other complications or adverse reactions
were reported in any other study patient.
 Angle-Supported Phakic Intraocular Lenses: The Phakic 6H2 167

Table 16-3

BEST-CORRECTED DISTANCE VISUAL ACUITY

Preoperatively 1 month 3 months 6 months
20/12.5 0 1 2 0
20/16 1 6 2 4
20/20 14 10 13 8
20/25 8 5 4 3
20/32 2 2 1 1
20/40 3 0 0 0
Worse than 20/40 0 0 0 0
Total 28 24 22 16

DISCUSSION months, respectively. This had no clinical significance in

The history of phakic IOLs for the correction of
myopia goes back 50 years. In 1953, Strampelli1 implant-
ed the first anterior chamber IOL in an aphakic eye to cor-
rect myopia. As early as 1959, Barraquer2,3,17 reported on
239 implantations, and Choyce4-7,18 reported his experi-
ence with 12 cases in 1964. Several complications were
reported in these early series, including corneal decom-
pensation. In these early reports, approximately 60% of
the lenses were explanted.19-22
In 1983 to 1984, Kelman introduced his anterior cham-
ber IOL implant design. Although introduced for the cor-
rection of aphakic refractive errors, the design was soon
adapted for myopic correction.1,23 In 1986, Dvali1 report-
ed his experience with the phakic anterior chamber IOL to
correct myopia. Later that year Fechner,8,9 Baïkoff,11-14
and Fyodorov1 became interested in IOLs in the phakic
eye. The ZB implant (Bausch & Lomb Surgical, Rochester,
NY) was born from their work and is considered one of the
first modern refractive implants with angular support.
In 1988, Baïkoff and Joly11-14 presented the initial
results obtained with the ZB phakic anterior chamber lens-
es for high myopia. Though results initially were promis-
ing, severe endothelial cell loss caused by the thick-edged
optic appeared within the first 2 years.11,13 Because of this
complication, the clinical investigation of the ZB lens was
suspended.
In 1990, Baïkoff11-14 introduced the ZB 5M. The ZB
5M myopic IOL had optic dimensions of 5-mm diameter,
an effective optical zone of 4 mm, thinned edges, and
reduced lens curvature produced by moving the optic pos-
terior 0.6 mm. The initial reports of the clinical results
with this lens were good.11-14 With further follow-up,
however, pupillary ovalization was seen in 16.38% to
22.6% of eyes after a mean follow-up of 35.8 and 58.6
the majority of cases but did lead to severe iris atrophy in
one of the eyes. Similarly, later reports11-14 suggested con-
tinued endothelial cell loss as high as 14.8%.
Following the ZB 5M (Bausch & Lomb Surgical,
Rochester, NY), Baïkoff11-14 introduced the NuVita
MA20 (Bausch & Lomb Surgical, Rochester, NY) myopic
implant, which had an effective optical zone of 4.5 mm, a
forward convex anterior lens face of the lens, and antire-
flective edges. The optical results were similar to those of
the ZB implants; however, the pupillary ovalization was
considerably reduced to less than 4% to 5%.
In 1991, Worst introduced the myopia claw lens.24 The
first design had a 4.5-mm optic diameter and a negatively
powered biconcave lens for myopic phakic eyes. Later, the
optic was altered into a convex-concave shape and the
optical diameter increased to 5.0 mm to reduce halos and
glare. In 1998, the lens was renamed the Artisan myopia
lens (Ophtec BV, Groningen, Netherlands)25-29 and the
design changed to a 6-mm optical diameter for all powers
up to -15.50 D.
Alio et al30,31 have helped to summarize the complica-
tions associated with angle-supported phakic anterior
chamber IOL implantation. They prospectively studied
263 eyes of 160 patients implanted with the Baïkoff ZB
5M and the ZSAL-4 (Morcher GmbH, Stuttgart,
Germany). Follow-up was from 1 to 7 years. Postoperative
iritis overall was reported at 4.56%. Night halos and glare
were reported, but the larger optic size with the Phakic
6H2 has substantially reduced this complication. High
intraocular pressure was noted in 7.2% of cases, likely
related to incomplete viscoelastic removal. Perhaps the
most critical factor reported was endothelial cell loss. At
month 3, there was 1.83% cell loss reported. At year 1, it
was 3.86% loss. At 7 years, the total cumulative loss of
central endothelial cells was 8.3%. Pupil ovalization
168 Chapter 16
occurred in 5.9%. Retinal detachment was observed in 3%
of cases.30,31
With respect to endothelial cell loss, earlier models of
both angle-fixated and iris-fixated lenses were associated
with higher endothelial cell loss for reasons previously
mentioned.11,20,21,30-32
The latest design change in the evolution of angle-fix-
ated IOLs for the treatment of myopia is the Phakic 6H2
lens.15 This lens has a 6-mm optic to minimize halos and
glare, and the footplates have a novel “ski tip” design that
helps to prevent iris capture in the angle. In the Phakic
6H2 lens, the haptics are extremely flexible, which pre-
vents the anterior displacement of the lens with peripher-
al compression. It is hoped that these design changes will
significantly reduce the problems seen with anterior cham-
ber phakic myopic lenses. Specifically, the flexible haptic
design and the thinner optic are designed to minimize any
progressive endothelial cell loss. The novel “ski tip” hap-
tics and the heparin coating are designed to minimize the
possibility of iris capture and iris inflammation, both fac-
tors which can lead to pupil ovalization.15
The results from this preliminary study demonstrate the
safety and efficacy of the Phakic 6H2 myopic IOL.
Specifically, we found the nomogram to be accurate. In
addition, there was no prolonged high intraocular pres-
sure, iris inflammation, or pupil ovalization. Further long-
term studies are ongoing and essential to examining the
endothelial cell loss.
SUMMARY
The Phakic 6H2 lens has a design that may reduce the
complications that have plagued previous myopic phakic
IOLs. Phakic anterior chamber lens designs have been suc-
cessively modified, leading to the development of the
Phakic 6H2 design. The results to date are promising, but
further long-term studies are needed to ensure the safety
and efficacy in the moderate to high myopic population.
REFERENCES
1. Werner L, Apple D, Izak A, et al. Phakic anterior chamber
intraocular lenses. Int Ophthalmol Clin. 2001;41(3):133-
151.
2. Barraquer J. Modification of refraction by means of intra-
corneal inclusions. Int Ophthalmol Clin. 1966;6(1):53-78.
3. Drews RC. The Barraquer experience with intraocular lens-
es, 20 years later. Ophthalmology. 1982;89:386-393.
4. Choyce DP. Intraocular lenses and Implants. London: HK
Lewis; 1964:153-155.
5. Choyce DP. Comparison of Choyce lenses. J Cataract
Refract Surg. 1987;13:344-345.
6. Choyce DP. The correction of high myopia. Refractive &
Corneal Surgery. 1992;8(3):242-245.
7. Horgan S, Fraser, S, Choyce, DP. Twelve year follow-up of
unfenestrated polysulfone intracorneal lenses in human
sighted eyes. J Cataract Refract Surg. 1996;22:1045-1051.
8. Fechner P, van der Heijde G, Worst J. The correction of
myopia by lens implantation into phakic eyes. Am J
Ophthalmol. 1989;107:659-663.
9. Fechner P, Strobel J, Wichmann W. Correction of myopia
by implantation of a concave Worst iris-claw lens into pha-
kic eyes. Refractive & Corneal Surgery. 1991;7:286-298.
10. Praeger DL, Momose A, Muroff L. Thirty-six month follow-
up of a contemporary phakic intraocular lens for the surgi-
cal correction of myopia. Ann Ophthalmology. 1991;23:6-
10.
11. Baïkoff G, Colin J. Damage to the corneal endothelium
using anterior chamber intraocular lenses for myopia.
Refractive & Corneal Surgery. 1990;6(5):383.
12. Baïkoff G. Phakic anterior chamber intraocular lenses. Int
Ophthalmol Clin. 1991;31(1):75-86.
13. Baïkoff G, Arne J, Bokobza Y, et al. Angle-fixated anterior
chamber phakic intraocular lens for myopia of -7 to -19
diopters. J Refract Surg. 1998;14(3):282-293.
14. Baïkoff G. Intraocular phakic implants in the anterior cham-
ber. Int Ophthalmol Clin. 2000;40:223-235.
15. Galin MA, Hirschman H. A Surgical Protocol for
Implantation of Phakic 6H2. Ontario, Canada: Ophthalmic
Innovations International, Inc; 2001.
16. Holladay JT. Refractive power calculations for intraocular
lenses in the phakic eye. Am J Ophthalmol. 1993;16:63-66.
17. Werblin TP. Barraquer Lecture 1998. Why should refractive
surgeons be looking beyond the cornea? J Refract Surg.
1999;15(3):357-376.
18. Downing J, Parrish C. Long-term results with Choyce-
Tennant anterior chamber intraocular lens implants.
J Cataract Refract Surg. 1986;12:493-498.
19. Perez-Santonja J, Iradier M. Chronic subclinical inflamma-
tion in phakic eyes with intraocular lenses to correct
myopia. J Cataract Refract Surg. 1996;22:183-187.
20. Perez-Santonja J, Iradier M, et al. Endothelial changes in
phakic eyes with anterior chamber intraocular lenses to cor-
rect high myopia. J Cataract Refract Surg. 1996;22:1017-
1022.
21. Mimouni F, Colin J, Koffi V, et al. Damage to the corneal
endothelium from anterior chamber intraocular lenses in
phakic myopic eyes. Refractive & Corneal Surgery.
1991;7:277-281.
22. Saragoussi JJ, Cotinat J, Renard G, et al. Damage to the
corneal endothelium by minus power anterior chamber
intraocular lenses. Refractive & Corneal Surgery.
1991;7:282-285.
23. Kaufman H, Kaufman SC, Beuerman RW. In defense of
phakic anterior chamber lenses. J Cataract Refract Surg.
1997;23:815-817.
24. Landesz M, Worst J, van Rij G. Long-term results of correc-
tion of high myopia with an iris-claw phakic intraocular
lens. J Refract Surg. 2000;16:310-316.
 Angle-Supported Phakic Intraocular Lenses: The Phakic 6H2
25. Maloney, RK, Nguyen LH, John M. Artisan phakic intraoc-
ular lens for myopia. Ophthalmology. 2002;109(9):1631-
1641.
26. Malecaze F, Hulin H, Pascal B, Fournié P. A randomized
paired eye comparison of two techniques for treating mod-
erately high myopia. Ophthalmology. 2002;109(9):1622-
1630.
27. Perez-Santonja J, Alio J, Jiminez-Alfaro I, Zato M. Surgical
correction of severe myopia with an angle-supported phakic
intraocular lens. J Cataract Refract Surg. 2000;26:1288-
1302.
28. Gimbel H, Ziemba S. Management of myopic astigmatism
with phakic intraocular lens implantation. J Cataract Refract
Surg. 2002;28:883-886.
169
29. O’Brien T, Awwad S. Phakic intraocular lenses and refracto-
ry lensectomy for myopia. Current Opin Ophthalmol.
2002;13:264-270.
30. Alio JL, de la Hoz F, Perez-Santonja JJ, et al. Phakic anteri-
or chamber lenses for the correction of myopia, a 7-year
cumulative analysis of complications in 263 cases.
Ophthalmology. 1999;106(3):458-466.
31. Landesz M, Worst JG, Van Rig G, et al. Long-term results
of correction of high myopia with an iris-claw PCIOL.
J Refract Surg. 2000;16:310-316.
32. Waring, G. Phakic intraocular lenses for the correction of
myopia—where do we go from here? Refractive & Corneal
Surgery. 1991;7:275-276.

Other Types of
Phakic Intraocular Lenses
David Rex Hamilton, MD, MS and Elizabeth A. Davis, MD, FACS
OVERVIEW
In addition to the phakic intraocular lenses (IOLs) dis-
cussed in the previous chapters, several new designs are
currently under investigation. These include the I-CARE
(Corneal, Paris, France), Kelman Duet (Tekia Inc, Irvine,
Calif), and ZSAL-4 Plus (Morcher GmbH, Stuttgart,
Germany) anterior chamber lenses.
I-CARE
This anterior chamber, angle-fixated phakic IOL (cur-
rently undergoing a multicenter trial in Europe) is
designed to correct myopia and hyperopia ranging from
-5.0 to -20.0 diopters (D) for myopia and +3.0 to +10.0 D
for hyperopia D (lens power available in 0.5-D steps). The
lens, made of 26% hydrophilic acrylic with an ultraviolet
(UV) filter, is available in four lengths: 12.0, 12.5, 13.0,
and 13.5 mm. The manufacturer recommends an anterior
chamber depth of at least 3.4 mm and an endothelial cell
density of at least 2000 cells/mm2.
Unique Features
This lens has a 5.75-mm optic and is foldable, allowing
injection through a 3.2-mm incision. The unique haptics
feature a symmetrical design with two 0.9-mm “feet” on
each haptic that evenly distribute forces and minimize
angle occlusion (Figures 17-1 to 17-3). The vaulting is cal-
culated so that the surfaces maintain the maximum possi-
ble distance from both the anterior capsule (0.84 mm) and
the corneal endothelium (2.07 mm to optic center).
17 Chapter
Clinical Results
Ten I-CARE lenses have been implanted at the time of
this writing in patients with myopia ranging from -11.0 to
-17.0 D. With 8 month follow-up, all cases are within 1 D
of intended correction with no significant complications.1
KELMAN DUET IMPLANT
This unique two-piece anterior chamber, angle-fixated
phakic IOL was designed by Charles Kelman, MD and
Tekia Inc to treat myopia from -8.0 to -20.0 D (Figure 17-
4). The polymethylmethacrylate (PMMA) haptics feature
a tripod design that is inserted first, separately from the
optic, through a 1.5-mm incision.
Unique Features
Figures 17-5A to 17-5H show the implantation tech-
nique for the Kelman Duet. Three mm and 1 mm incisions
are made through clear cornea at the 3:00 and 9:00 posi-
tions, respectively (Figure 17-5A). Viscoelastic is intro-
duced into the anterior chamber (Figure 17-5B). The hap-
tic assembly is snaked into the anterior chamber through
the 3-mm incision (Figure 17-5C), and angle placement is
verified with gonioscopy (Figure 17-5D). The silicone
optic is loaded in the injector right side up with the
attachment tabs folded upward (Figure 17-5E). The optic
is injected into the anterior chamber (Figure 17-5F). A
hook is then used to grasp each optic tab and engage it
into its respective haptic (Figures 17-5G and 17-5H). This
design not only allows insertion of an anterior chamber
172 Chapter 17

Figure 17-1. I-CARE phakic IOL features a 5.75-mm optic

and haptics with 0.9 mm “feet,” which minimize angle Figure 17-2. I-CARE phakic IOL demonstrating minimal angle
occlusion but provide good stability (courtesy of touch of haptic foot (arrow) (courtesy of Alessandro Mularoni).
Alessandro Mularoni).

Figure 17-4A. Kelman Duet implant features an asymmetric, tri-

pod-shaped PMMA haptic and a separate 5.5-mm silicone optic
Figure 17-3. I-CARE phakic IOL showing good centration
(courtesy of Tekia Inc).
with dilated pupil (courtesy of Alessandro Mularoni).

Figure 17-4B. The assembled Kelman Duet implant (courtesy of Figure 17-5A. Implantation technique for Kelman Duet implant
Tekia Inc). system. Three-mm and 1-mm incisions are made through clear
cornea at the 3:00 and 9:00 positions, respectively (courtesy of
Tekia Inc).
 Other Types of Phakic Intraocular Lenses 173

Figure 17-5C. Implantation technique for Kelman Duet implant

Figure 17-5B. Implantation technique for Kelman Duet implant system. The haptic assembly is snaked into the anterior chamber
system. Viscoelastic is introduced into the anterior chamber through the 3-mm incision (courtesy of Tekia Inc).
(courtesy of Tekia Inc).

Figure 17-5E. Implantation technique for Kelman Duet implant

Figure 17-5D. Implantation technique for Kelman Duet implant
system. The silicone optic is loaded in the injector right side up
system. Angle placement is verified with gonioscopy (courtesy of
with the attachment tabs folded upward (courtesy of Tekia Inc).
Tekia Inc).

Figure 17-5F. Implantation technique for Kelman Duet implant

system. The optic is injected into the anterior chamber (courtesy Figure 17-5G. Implantation technique for Kelman Duet implant
of Tekia Inc). system. A hook is then used to grasp each optic tab and engage
it into its respective haptic (courtesy of Tekia Inc).
174 Chapter 17
Figure 17-5H. Implantation technique for Kelman Duet implant
system. A hook is then used to grasp each optic tab and engage
it into its respective haptic (courtesy of Tekia Inc).
lens through a small incision, thus minimizing potential
induced astigmatism, but also allows for subsequent
exchange of the optic through the same small incision
should the patient’s refractive error change in later years.
Because this system is designed to treat high myopia, the
ease of optic exchange may make the lens particularly
attractive for young patients.
Clinical Results
European trials are underway, with six lenses placed by
Jorge L. Alio, MD. All patients experienced an improve-
ment in best-corrected visual acuity of one to two Snellen
lines.2 US clinical trials are anticipated to begin in 2003.
ZSAL-4 PLUS
This lens is the fifth generation in an evolving series of
vaulted, conventional, angle-supported anterior chamber
lenses. The precursor to this series was the ZB lens,
designed by Joly et al,3 and consisting of a modified
Kelman 4-point fixation Multiflex lens with a biconcave
optic. This lens was associated with high endothelial cell
loss.4,5 Baïkoff modified the lens by increasing the lens-
corneal space by 0.6 mm. The new lens, the ZB 5M,
reduced the endothelial cell loss but encountered night
vision problems and pupil ovalization.6,7
In an effort to avoid these complications, Perez-
Santonja and Zato developed a vaulted, convex-concave
angle-supported lens. Figure 17-6 describes the first four
iterations of the ZSAL lens design. The first iteration,
ZSAL-1, was a prototype with the lens angulated anterior-
ly 15 degrees. Although the ZSAL-2 and 3 increased the
angulation to 17 and 18 degrees, respectively, the posteri-
or edge of the optic was still too close to the iris. The
Figure 17-6. The first 4 iterations of the ZSAL lens design. A. The
first iteration, ZSAL-1, was a prototype with the lens angulated
anteriorly 15 degrees. B. and C. Although the ZSAL-2 and 3
increased the angulation to 17 and 18 degrees, respectively, the
posterior edge of the optic was still too close to the iris. D. The
fourth generation, ZSAL-4, was changed to a plano-concave
design with a 19-degree anterior angulation (reprinted with per-
mission from Perez-Santonja JJ, Alio JL, Jimenez-Alfaro I, Zato
MA. Surgical correction of severe myopia with an angle-sup-
ported phakic intraocular lens. J Cataract Refract Surg.
2000;26(9):1288-1302).
fourth generation, ZSAL-4, was changed to a plano-con-
cave design with a 19-degree anterior angulation.
Clinical Results
A recent study examined implantation of the ZSAL-4
lens in 23 eyes of 16 patients with a mean preoperative
refractive error of -19.56 D (range: -16.75 to -23.25).8
Postoperatively there was a mean two line improvement in
best corrected acuity. Mean endothelial cell loss was 4.18%
at 24 months. The new design afforded a reduction in night
halos but still suffered from pupil ovalization (Figure 17-7),
IOL rotation, and low-grade postoperative uveitis. These
remaining complications appear to be related to problems
with the haptic-angle interaction. With this in mind, a fifth
generation ZSAL-4 Plus was designed with a thinner con-
necting bridge between the optic and the first footplate and
a thicker connecting bridge between both footplates to
increase haptic flexibility and disperse compression forces
against angle structures. In addition, the ZSAL-4 Plus fea-
tures an effective optical zone enlarged to 5.3 mm from 5.0
mm in the previous version, hopefully affording further
reduction in night time visual disturbances.8
SUMMARY
The IOL implant for cataract surgery underwent many
iterations before optically effective, biocompatible, and
surgically efficient foldable lenses were created. Indeed,
the latest generation of IOLs are pushing the envelope of

Figure 17-7. Pupil ovalization 2 years after implantation of
ZSAL-4 phakic intraocular lens (reprinted with permission
from Perez-Santonja JJ, Alio JL, Jimenez-Alfaro I, Zato MA.
Surgical correction of severe myopia with an angle-sup-
ported phakic intraocular lens. J Cataract Refract Surg.
2000;26(9):1288-1302).
small incisions and new optic designs that correct higher
order aberrations. Similarly, phakic IOL designs are still in
their early generations, with many innovative modifica-
tions that will improve their safety and efficacy to come.
In Chapter 21, we will examine some of these new designs
as well as some innovative ideas for future generations of
refractive IOLs.
Other Types of Phakic Intraocular Lenses 175
REFERENCES
1. Cimberle M. Corneal injectable phakic IOL demonstrates
good stability and visual outcome. Ocular Surgery News
[serial online]. Available at: http://www.osnsupersite.com.
Accessed July 22, 2003.
2. Angelucci D. Innovation Spotlight: Two-piece phakic lens
may correct high myopia. Eye World [serial online].
Available at: http://www.eyeworld.org. Accessed July 22,
2003.
3. Joly P, Baïkoff G, Bonnet P. Mise en place d’un implant neg-
ative de chamber anterieure chez des sujets phakes. Bull Soc
Ophth Fr. 1989;89:727-733.
4. Mimouni F, Colin J, Koffi V, Bonner P. Damage to the
corneal endothelium from anterior chamber intraocular
lenses in phakic myopic eyes. Refract Corneal Surg.
1991;7:277-281.
5. Saragoussi JJ, Cotinat J, Renard G, et al. Damage to the
corneal endothelium by minus power anterior chamber
intraocular lenses. Refract Corneal Surg. 1991;7:282-285.
6. Baïkoff G, Arne JL, Bokobza Y, et al. Angle-fixated anterior
chamber phakic intraocular lens for myopia of -7 to -19
diopters. J Refract Surg. 1998;14:282-293.
7. Alio JL, de la Hoz F, Perez-Santonja JJ, et al. Phakic anteri-
or chamber lenses for the correction of myopia; a 7-year
cumulative analysis of complications in 263 cases.
Ophthalmology. 1999;106:458-466.
8. Perez-Santonja JJ, Alio JL, Jimenez-Alfaro I, Zato MA.
Surgical correction of severe myopia with an angle-support-
ed phakic intraocular lens. J Cataract Refract Surg.
2000;26:1288-1302.

Bioptics
Roberto Zaldivar, MD; Susana Oscherow, MD; and Virginia Piezzi, MD
INTRODUCTION
We began using the technique of bioptics in 1996 and
have continuously adjusted the indications since then
according to our results.
In 1995 we chose to not use anterior chamber lenses
any more and to only employ the phakic posterior cham-
ber intraocular lens (IOL) (Implantable Contact Lens
[ICL]) (STAAR Surgical AG, Nidau, Switzerland) (Figure
18-1). We used to correct residual astigmatism and myopia
with radial keratotomy or arcuate keratotomy. Then we
began to perform ablations with laser in-situ keratomileu-
sis (LASIK) so we also used this to correct residual defects
after ICL.
After these first cases of bioptics, we have widely
expanded the technique. Using a foldable lens implanted
through a 2.8- to 3.0-mm incision, the astigmatism induc-
tion is minimal, so we can propose to the patient a second
procedure to treat the pre-existing astigmatism. Because
we observe visual acuity quality and quantity improvement
in our patients, we often offer bioptics to patients after
their preoperative examination.
Initially, we thought this combined technique was a
very good option for those young patients with extreme
refractive errors, avoiding the complications related to
clear lensectomy.
We have shared our experience in other publications
and congresses, and we have demonstrated that this tech-
nique presents significant advantages. It is essential to
properly select the patients, and careful surgical technique
in experienced hands achieves the desired results.
18 Chapter
INDICATIONS
Bioptics implies two different procedures in two differ-
ent planes of the eye, so patient inclusion criteria depends
on many factors.
• The first procedure, intraocular, is the ICL implanta-
tion
• The second procedure, corneal, is LASIK, laser
epithelial keratomileusis (LASEK), or photorefrac-
tive keratectomy (PRK)
Usually, we perform this surgery in patients who are
older than 19 years of age with refractive stability, exclud-
ing severe general pathologies, such as immunosuppres-
sion or diabetes, vitreoretinal pathologies, cataract, glau-
coma, uveitis, or other intraocular inflammatory disease.
To perform the superficial corneal procedure, it is nec-
essary to have proper pachymetry and to exclude any
patients with severe dry eye; corneal dystrophy; corneal
degenerations, such as keratoconus; and infections, such as
herpes.
We have observed that hyperopic patients achieve
refractive stability at an earlier age than myopic patients.
We utilize this procedure in patients with a spherical
equivalent larger than -10 diopters (D) in myopic eyes and
more than +5.00 D in hyperopic ones.
Although some patients with high myopia (-10 to -15
D) have been corrected with laser surgery, we prefer to
correct patients with high myopia with this double proce-
dure because a laser ablation of this magnitude will result
in a small transition and optical zone. Laser consumes
corneal tissue, and in high corrections can decrease the
178 Chapter 18
Figure 18-1. ICL V4 model.
quality of vision. Some eyes may not have enough corneal
tissue to retreat in the case of undercorrection without a
high risk of inducing iatrogenic ectasia.
When using laser in hyperopic patients with more than
+5.00 D or corneal curvature superior to 48.00 D, we can
generate tear film disruption, changes in stromal architec-
ture, and corneal irregularity that diminishes visual quality
and comfort.
In hyperopic patients we have to keep in mind their age
and the potential degree of their accommodation influenc-
ing the refraction. We always have to perform the refrac-
tion under cycloplegia because young patients usually
have strong accommodation. When accommodation is
significant, we can induce an accommodative myopic
result in cases in which we correct the whole refractive
error. This situation is very uncomfortable for the patient.
In patients with strong accommodation we prefer to use
LASIK to correct only a part of the refractive error based
upon two measurements: subjective and cycloplegic
refraction (see Case Report: Accommodation in a
Hyperopic Patient on p. 179).
The situation mentioned below and results obtained
with new and improved software for laser treatment of
hyperopia have led us to decrease the use of implants in
hyperopic patients. In general, we can satisfy all patient
needs using only LASIK. In the above case we tried to cor-
rect the entire hyperopic error, but the patient continued to
have significant levels of accommodation inducing meas-
ured myopia. Nowadays, in young patients we do not cor-
rect the whole hyperopic defect to prevent this problem.
In this group of patients we have in mind work activity.
In artists or office workers (ie, those who rely on near
vision), residual myopia can be helpful, but in pilots or driv-
ers this myopia can be dangerous and uncomfortable.
It is also very important to not forget the anterior
chamber depth and white-to-white (W-to-W) measure-
ment when we select the surgical procedure. Intraocular
implants are not recommended in patients with shallow
anterior chambers and small eyes.
There are some patients that have special characteris-
tics and that do not meet the parameters mentioned above.
In this group we only implant the ICL and we do not per-
form LASIK. We can classify them as follows:
A. Patients with thin corneas. Within this group we
include patients that primarily present with low
pachymetry and patients with postsurgical reduction
of corneal thickness (eg, eyes previously operated
with laser that present with regression or in which
the initial refraction increases).
B. Forme fruste keratoconus. In this group of patients,
as in keratoconus, we can correct the spherical part
of their refractive defect with the phakic IOL. The
astigmatism cannot be corrected with laser so we
prescribe glasses. This technique allows reduction of
the total defect, which is especially useful in patients
with contact lens intolerance and discomfort with
glasses due to the severity of the refraction.
In situations that are not at risk of corneal ectasia, it
is possible to employ arcuate incisions, adding one
suture 90 degrees away from the incisions to
increase the corrective effect of the incisions.
C. Keratoconus status I or II, stable, or slowly progres-
sive. This group presents the same limitations as
patients with forme fruste keratoconus, but another
option is to put in intracorneal rings to correct resid-
ual astigmatism.
D. Children with high anisometropia and contact lens
intolerance. Although we try to avoid this surgery in
very young patients, this procedure could be an
interesting alternative to prevent amblyopia. In
these cases, if there is a residual defect, the second
part of the surgery (laser) is performed when the
child reaches refractive stability (see Case Report:
Child With Anisometropia on p. 179).
E. Postepikeratophakia. The residual corneal bed after
this technique typically does not allow the use of
laser to correct myopic residual refraction even
though it is typically low.1
Additionally, in patients that have had penetrating ker-
atoplasty we utilize bioptics to correct high residual refrac-
tive defects. In these cases the graft has to be stable with
no signs of rejection. We proceed first with the ICL
implant, having evaluated the corneal endothelium with
specular microscopy and trying to perform a very careful
and quick surgical procedure in order to minimize trauma
to the cornea. We perform the flap 6 months or more after
removing all graft stitches. One month later we measure
the refraction and proceed with the laser ablation. We per-
form LASIK in two steps because the fibrous ring in the
graft-host interface sometimes induces refractive changes,
especially astigmatism.
 Bioptics 179

Case Report: Accommodation in a Hyperopic Patient

Sex: Female
Age: 25 years old
Rx UCVA BCVA Cycloplegia
OD +3.00 +2.00 x 70 degrees 20/80 20/40 +7.75 +2.00 x 70 degrees
OS +2.00 +3.25 x 90 degrees 20/80 20/30 +7.75 +3.25 x 95 degrees
Surgery Date = May 1996
ICL Power
OD +12.5 D OS + 9.50 D
Rx Postimplantation UCVA Postimplantation BCVA Postimplantation
OD -1.50 -2.00 x 160 degrees 20/80 20/40
OS -1.00 +2.50 x 105 degree 20/80 20/40

The patient presented with good near vision and yet she was uncomfortable with her distance vision. We per-
formed LASIK in both eyes. At her last follow up, the measurements were as follows:
Rx UCVA BCVA
OD -1.00 -0.50 x 180 degree 20/40-2 20/40
OS -1.75 x 180 degree 20/50 20/40

At present the patient is still uncomfortable with distance vision and with variable and difficult refraction. In
agreement with the patient, we decided to wait for retreatment with a laser.

Case Report: Child With Anisometropia

Sex: Male
Age: 8 years old (contact lens intolerant)
Rx UCVA BCVA
OD plano -3 x 180 D OD:20/50 OS: 20/800
OS -17.5 -2.5 x 15 OD:20/30 OS: 20/150
OS was implanted 2 years ago with no complications.

Postoperative Results
Rx UCVA: BCVA:
OS: -4.25 -2.25 x 20 20/100 20/60

All parameters are inside normal ranges, and he is wearing glasses to correct residual refraction.

In our experience, no patient has presented corneal
rejection after both procedures.
PREOPERATIVE WORKUP
We first perform UCVA, BCVA, keratometry, corneal
topography (anterior and posterior corneal surface) with
the Orbscan topographer (Orbtek Inc, Salt Lake City,
Utah), ultrasonic and slit lamp pachymetry (CompuScan,
P-Storz Instrument Company, St. Louis, Mo), noncontact
specular microscopy (Konan Noncon Robo, Hiogo,
Japan), ultrasonography and ecometry, biomicroscopy,
applanation tonometry, anterior segment infrared picture
(Anterior Segment Analysis System-EAS 1000, Nidek,
Japan), dilated eye fundus, contrast sensitivity test, and
corneal sensation evaluation. If necessary, gonioscopy and
B-scan ultrasonography can be performed. Prior to the
implant, we also require a routine physical examination
and blood analysis, coagulation, and EKG.
As we said above, it is very important to observe ante-
rior chamber depth and W-to-W measurements in hyper-
opic eyes in order to avoid complications after implanta-
180 Chapter 18
tion, such as anterior chamber crowding, angle occlusion,
or pigment dispersion, that will provoke ocular tension
increases. In cases where we offer the patient a personal-
ized ablation, we perform aberrometry and proceed
according to the higher order aberrations that are found.
In our institute we use two different systems to diag-
nose and treat aberrations. The Bausch & Lomb 217
Zyoptix System (Rochester, NY) combines conventional
laser with a 2-mm spot with another spot of 1 mm; the
shape is a gaussian truncated curve and it also includes a
120 Hz eye tracker. Aberrations are detected with a
Zywave that uses Hartmann-Shack principles.
Topography is taken using Orbscan. All the information is
processed with Zylink software.
The other equipment used is the Nidek Advanced
Vision Excimer Laser System (Navex, Nidek, Japan) com-
bined with the OPD Scan, wavefront aberrometer, Final
Fit software that integrates and makes calculations, and the
excimer laser EC 5000 CX series with multipoint ablation.
This equipment also has an eye tracker system.
SURGICAL TECHNIQUE
Although during the preoperative evaluation we can be
almost sure which technique is going to be used, the defin-
itive decision is made after completing all of the examina-
tions and tests. It is important to explain to the patient the
reasons for the possible change in plan after the initial
exam. This way the patient will be well informed and have
less anxiety about the surgery.
Phakic Implant
We perform the intraocular implantation as the first
step and use the fifth generation of STAAR’s Collamer ICL
V4. The day before surgery we perform two iridotomies
with the neodymium:yttrium-aluminum-garnet (Nd:YAG)
laser. In some cases we apply argon-green laser prior to the
Nd:YAG to prevent iris bleeding. These iridotomies help
to prevent increases in intraocular tension, which is an
important issue related to the surgery. Iridotomy patency
is verified before surgery. When aqueous humor filtration
is not satisfactory, the surgeon is notified so that during
surgery, he or she can perform a surgical iridotomy or iri-
dectomy to avoid pupillary block. We have to remark
upon the difference between both techniques mentioned
above: surgical iridectomy refers to the traditional proce-
dure (ie, cutting and removing a piece of iris). The second
option (ie, surgical iridotomy or iris flap) is performed as
follows.
Once the lens has been placed with a miotic pupil, we
introduce the Zaldivar iridectomy forceps (ASICO,
Westmont, Ill) by paracentesis, grabbing the iris at 1.5 mm
central to its insertion and performing an incomplete cut
with the Zaldivar iridectomy scissors. With the pha-
coemulsification cannula, we elongate one lip of the iris
over the other, obtaining a flap that acts as a valve and cre-
ating an invisible iridotomy. In the same maneuver we
continue suctioning the residual viscoelastic. To confirm
the valve efficacy, we place the cannula in order to check
the liquid flow that raises the flap.
The advantage of the iris flap is to maintain aqueous
humor flow from the anterior to the posterior chamber,
keeping the iris tissue almost untouched. This eliminates
halos or glare produced by conventional iridectomy.
It is very important to decrease the patient’s anxiety
prior to surgery by explaining how it will be performed.
We always recommend oral alprazolam preoperatively.
One hour before surgery, tropicamide 1%, phenylephrine
2.5%, diclofenac, gentamicin, or a fluoroquinolone are
applied serially. Patients are then taken to the preoperative
holding area where they are fitted with a hair net and their
eyes and lids are cleaned and scrubbed with an iodine eye
scrub.
Anesthesia
We use peribulbar or topical anesthesia, depending on
the specifics of each individual case. Peribulbar anesthesia
is frequently used in young and anxious patients because
the anterior chamber collapse and iris extrusion from pos-
itive pressure are more frequent with topical anesthesia
and can be difficult to control. Lidocaine 2%, duracaine
0.5%, and hyaluronidase are used for peribulbar anesthe-
sia. When optimal dilation, anesthesia, and akinesia are
obtained, the patient is taken to the operating room. The
eyelids are prepared with povidone-iodine, the head is
draped with a sterile field, and a lid speculum is placed.
The first step consists of choosing the ICL length. In
myopic patients we add 0.5 mm to the obtained measure-
ment; in hyperopic patients, we use the value without any
addition. Selection of the proper lens length is essential to
achieving an optimum vault and to preventing decentration.
A 2.8-mm temporal clear corneal incision and superior
paracentesis are performed with the Zaldivar anterior pro-
cedure (ZAP) diamond knife (ASICO, Westmont, Ill).
Nonpreserved lidocaine is instilled into the anterior cham-
ber if topical anesthesia is employed. Then hydroxypropyl
methylcellulose is injected. The viscoelastic should have
good cohesive properties and be of low viscosity to facili-
tate its removal following ICL implantation. As in any
other surgery utilizing intraocular maneuvers, corneal
endothelium protection is very important.
Until loading, the ICL should be kept well-hydrated in
a sterile container of balanced salt solution. With the help
of the operating microscope, the IOL is positioned in the
lens injector cartridge. We do not recommend a forceps
insertion because of the possibility of inadvertently dam-

aging the crystalline lens. Within the lens injector car-
tridge, the ICL should be oriented so that its long axis is
aligned with the center of the cartridge and both sides of
the ICL must be completely within the loading area.
Viscoelastic will facilitate these manipulations. In order to
protect the IOL from the injector arm, a 1.0-mm diameter
wedge of Merocel microsurgical sponge (Solan
Ophthalmic Products, Jacksonville, Fla) is cut and placed
behind the cartridge within the lens injector.
The injector tip is then placed within the wound (but
not into the anterior chamber), and the lens is slowly
injected into the anterior chamber anterior to the iris
plane, ensuring proper orientation. During insertion, the
ICL tends to rotate upside down. Current ICL models are
angulated, so proper orientation is very important. As
positioning holes, the ICL has two dimples on the anteri-
or surface. One hole is located next to the distal footplate,
and the second is next to the proximal one. An upside
down lens would show inversion of these positioning
holes. Often, it is difficult to assess ICL orientation while
the lens is inside the injector. Rotating the injector while
inserting the ICL, which maintains correct lens position
throughout the procedure, facilitates proper orientation.
We recommend not repositioning the lens inside the eye
in the case of an inverted ICL. Instead, it should be
removed with forceps and then reinjected in its proper ori-
entation, minimizing the risk of traumatic cataract.2-3
After proper insertion, the ICL should rest anterior to
the iris with the footplates reaching just beyond the pupil
margin. Each ICL footplate has to be positioned inde-
pendently, placing gentle posterior pressure on the lens
with the Zaldivar ICL manipulator (ASICO, Westmont,
Ill). We usually begin positioning the temporal haptic. We
recommend against attempting to lift the iris.
In order to ensure that the iris has not captured the
IOL, acetylcholine is injected into the anterior chamber to
induce miosis. We then remove the remaining viscoelastic
with gentle irrigation and aspiration using the AMO
Prestige phacoemulsification system (Allergan, Irvine,
Calif). To guard against ocular hypertension, it is impor-
tant to remove all remaining viscoelastic.
We never forget to protect corneal endothelium, and
hyperopic eyes that usually present shallower anterior
chambers solicit extra care during phakic IOL insertion.
But, in fact, the surgical maneuvers are identical in myopic
and hyperopic eyes.
At the end of the surgical procedure, topical
tobramycin-dexamethasone, gentamicin, and 500 mg of
oral acetazolamide are given to the patient. Eyes that
receive peribulbar anesthesia are patched. Eyes that
receive topical anesthesia are given protective eye shields
for bedtime use only. Five hours after the surgery we
examine the patient. Postoperative medications include
ciprofloxacin four times a day (qid) for 1 week, lotepred-
Bioptics 181
nol 1% qid for 1 month, brimonidine tartrate 0.2% twice
a day (bid) for 1 month, and oral dexamethasone 4 mg per
day for 1 week.
In bilateral cases, we implant the second eye 48 hours
after the first eye because of the high anisometropia that
occurs when only one eye is implanted.
ICL Follow-up
We evaluate UCVA, BCVA, manifest refraction, bio-
microscopy, intraocular tension, anterior chamber depth,
ICL position, vault, pigment dispersion, and iridectomy
permeability at all postsurgical follow-up visits as well as
pre- and post-LASIK.
LASIK Procedure
As a second step to complete myopic, hyperopic,
and/or astigmatism correction, we perform LASIK 4 weeks
or longer after ICL implantation. LASIK itself is a highly
predictable technique in low to moderate myopic and
hyperopic cases with or without astigmatism.4-8 Other
colleagues perform an automated lamellar keratoplasty
prior to intraocular surgery in a similar manner, especially
when an anterior chamber IOL is used.9 We prefer the
sequence of the ICL first followed by the LASIK (as
detailed in this chapter) because the ICL is located in the
posterior chamber and the risk of endothelial damage dur-
ing the flap dissection does not exist. Another reason to
perform LASIK after the ICL is the increased incidence of
epithelial ingrowth caused by the repeated manipulation
of the flap.
We perform LASIK using conventional parameters and,
as explained above, in personalized ablation cases, we per-
form special preoperative studies relating to this proce-
dure. At the current time we have performed personalized
ablations in 17 patients (25 eyes). Results obtained with
this new method of treatment are better than convention-
al bioptics with respect to safety and outcomes.
Furthermore, none of these eyes lost lines of BCVA.
The procedure is similar in unilateral or bilateral cases.
In bilateral cases we perform LASIK simultaneously a
month after the first surgery. The patient is prepared for
surgery once in the preoperative theater. The lids, eye-
brows, and eyelashes are cleaned and disinfected using
povidone-iodine solution. Antibiotic and anesthetic drops
are instilled. We do not use pilocarpine drops, and we
avoid dilation for surgery in order to minimize difficulties
on ablation centration.
In bilateral cases we always start with the right eye, but
according to the equipment with which we have decided
to work, the patient will or will not be transferred from
one piece of equipment to the other. The patient is taken
to the excimer laser bed and placed in the position in order
to begin presurgical steps consisting of lid and field drape
182 Chapter 18
placement (especially isolating the eyelashes). In the eye
that will be operated on second, we instill artificial tears
and close it in order to allow better fixation for the eye
that will be operated on first.
Once positioned, we mark the cornea using gentian
violet. We place the suction ring and activate the vacuum,
testing the IOP increase by the pupil movement and then
digitally. The flap is created and its size depends on the
procedure selected for the patient. When we release the
suction, the microkeratome is removed. We lift the flap,
check eye position and fixation, and proceed to the abla-
tion. During the session we control the tissue humidity,
drying it with a surgical sponge if necessary. The flap is
protected with the same sponge so the surgeon does not
need to change it during the ablation.
Once finished, the flap is repositioned, the interface is
carefully cleaned, and a soft flow of oxygen is used to dry
the corneal surface. Tobramycin, ketorolac, and artificial
tears of hyaluronic acid are then instilled. The lid specu-
lum is removed and proper flap position is checked again.
If we proceed with the other eye, the first one is occluded
with adhesive tape, and the contralateral eye is uncovered,
and we proceed in the same manner as the first eye.
Bioptics in Pseudophakic Patients
Bioptics technique, initially performed on phakic
patients only, has extended in our institute and in other
ophthalmologic centers to other group of patients, includ-
ing pseudophakic patients. Residual defects or previous
astigmatism can be treated as in phakic eyes.
Patients with cataract and astigmatism have two
options depending on the refractive error: phacoemulsifi-
cation plus limbal relaxing incisions or, if the astigmatism
is greater than -2.00 D, we prefer LASIK.
One to 3 months after phacoemulsification we perform
LASIK according to conventional techniques. It is impor-
tant for us to mention that no complication has occurred
in our practice that is associated with these procedures,
even in extremely myopic cases. Furthermore, comparing
phakic and pseudophakic eyes, we did not find more com-
plications after LASIK in the pseudophakic group, as we
would expect because of their age.
Retinal complications related to suction did not occur in
these patients either, even though we had performed a pos-
terior capsulotomy in three eyes before performing LASIK.
The refraction in these eyes has been stable over a 4-year
time period. In the pseudophakic group UCVA and BCVA
improved postoperatively, with 100% of the patients reach-
ing their maximal visual acuity during the first month.
LASIK FOLLOW-UP
Patients treated with LASIK are examined approxi-
mately 30 minutes after surgery. After this first examina-
tion, patients can leave the center and go home. They
were already instructed preoperatively to keep their eyes
closed for a period of 2 hours.
Patients must come in for a follow-up examination 24
hours after surgery. At this examination we measure
UCVA, BCVA, automated refraction, keratometry, subjec-
tive refraction, and biomicroscopy. We perform follow-
ups at 1 month, 6 months, 1 year, and once a year there-
after. It is very important to check flap conditions and
characteristics (eg, proper apposition, foreign body in the
interface, folds, diffuse lamellar keratitis, and dry eye). We
must always keep in mind that these patients have had two
different surgical procedures, and we must check all
parameters related to both surgeries.
COMPLICATIONS
We will study complications separately for each tech-
nique because we have not found complications associated
with bioptics.
ICL Implantation
Intraoperative Complications
In order to obtain a correct IOL implantation behind
the iris, we need a large pupil diameter. Maneuvers must
be gentle, avoiding crystalline lens anterior surface touch.
We also have to control pupillary edge during miosis to
prevent the IOL from hitching. Viscoelastic has to be
removed carefully in order to avoid increases in intraocu-
lar tension and viscoelastic retention between lens and ICL
that provoke anterior capsule transparency loss.
In hyperopic patients that usually present with narrow
anterior chambers, we have to use extreme caution while
making surgical maneuvers to avoid corneal endothelial
damage.
Early Postoperative Complications
We examine patients 6 hours after surgery, checking
anterior chamber depth, pupillary diameter, iridotomy
patency, and intraocular tension. The most feared compli-
cation is pupillary block, but we can manage this situation
with iridotomies and by choosing a correct IOL length
that creates a proper vault. Large IOLs can provoke pupil-
lary block even with patent iridotomies. We can avoid this
complication by measuring W-to-W carefully. In this peri-
od we also have to take special care to prevent infections.
Late Postoperative Complications
Since we began using posterior chamber implants in
phakic patients (1993), we have gained experience in pre-
vention and management of possible complications relat-
ed to this surgical procedure.
The management of the complication is chosen based
upon the refractive results, stability, and severity of the
complication. When offering any kind of treatment to the

Figure 18-2. Pha-
kic anterior IOL
complications—
pupillary elonga-
tion and iris atro-
phy. The pupil-
lary elongation
and iris atrophy
were resolved
after the IOL was
rotated.
Figure 18-4. Vault classification: vault type 2 and vault type 3.
patient, we must be able to solve all possible complications.
The surgeon and his team have to know the way to manage
complications in order to perform a safe procedure.
The most difficult complications that we must prevent
are corneal decompensation from endothelial damage, iris
atrophy, pupillary elongation, cataract induction, and
intraocular pressure (IOP) increase (Figure 18-2). The first
four situations are clearly related to anterior chamber
implants, so we decided to use retroiridian IOLs because
the eye can not recover to the preoperative status after suf-
fering these severe complications. It is very important to
have experience with posterior chamber implants in order
to prevent other complications.
Anterior subcapsular cataract induction was a complica-
tion we observed between 1996 and 1998. All of these
patients had third- and fourth-generation implants, they
were highly myopic eyes (more than -16 D), and the vault
(ie, the space between implant and lens) was small or
absent. Cataracts were clinically evident 6 to 12 months
after the implant. It was annular and coincident with the
IOL optical zone. This observation suggested some type
of metabolic disorder or oxygen decrease in the lens ante-
rior surface provoked by disturbed aqueous humor circula-
tion.
Bioptics 183
Figure 18-3. Vault classification: vault type 0 and vault type 1.
We analyzed our patients by taking slit lamp photo-
graphs with EAS 1000 equipment, and we could demon-
strate the importance of vault in cataract genesis. Because
these observations were done, we classified vault as follows.
Vault Classification
• Vault type 0 (T0): no space between the ICL and the
lens
• Vault type 1 (T1): small central space, with periph-
eral touch of the lens
• Vault type 2 (T2): small space across the ICL
• Vault type 3 (T3): significant space across the entire
ICL (Figures 18-3 and 18-4)
First and second generations of the ICL had an excel-
lent vault; in fact, no case developed anterior subcapsular
cataract. After our experience, we began using a maximum
power of -15.50, ICL V4 model and we paid special atten-
tion to IOL length calculated according to W-to-W meas-
urement. In our experience we know that a patient with an
appropriate vault (ie, T2 to T3) will not develop an ante-
rior subcapsular cataract (Figures 18-5 and 18-6). We have
observed that no hyperopic patient has developed anteri-
or subcapsular cataract. All implanted eyes have had prop-
er vault (Figure 18-7).
Intraocular Tension
As a late postoperative complication, intraocular ten-
sion increase is related to pigment dispersion.
Some situations alone or together cause dispersion.
Some of them are as followed:
• Laser Nd:YAG preoperative iridotomies
• Surgical maneuvers
• Iris posterior face touch with ICL
In postoperative follow-up we always evaluate pigment
dispersion. In our patients, including those in which the
implant was inserted with a rotational technique, we did
not find any case presenting with pigmentary glaucoma
associated with the implant.
184 Chapter 18
Figures 18-5. Mini Case Report: Extreme myopic patient with
bioptics in both eyes. Note the difference in ICL length selection
and resulting vault. The patient developed a typical cataract in
OD.
Figure 18-7. Hyperopic ICL implantation at 8-year follow-
up. Lens densitometry. Proper vault. Cataract absence.
Although we are talking about late complications, we
want to mention that two eyes had to be explanted
because of abnormal pigment dispersion in the early post-
operative period that provoked pupillary block by iridoto-
my occlusion. One was a hyperopic patient.10 The other
one was a myopic patient with a similar implant in the
contralateral eye without complications (see Case Report:
Abnormal Pigment Dispersion on p. 185).
We have observed that in all cases pigment dispersion
did not increase in time or else it diminished by aqueous
washing.
LASIK Complications
LASIK has been revolutionary in refractive surgery. It
presents many advantages, such as performing it in both
eyes simultaneously, even in bioptics patients. This tech-
nique was widely accepted by surgeons and patients
because there are few complaints and patients have fast
visual recovery if seen early in the postoperative period.
Otherwise, it requires more training on equipment man-
agement, especially with the microkeratome, which is an
essential tool for this surgical procedure.
Figures 18-6. Mini Case Report: Extreme myopic patient with
bioptics in both eyes. Note the difference in ICL length selection
and resulting vault. The patient developed a typical cataract in
OD.
Corneal anterior surface topography, posterior surface
evaluation, and pachymetry are keys to deciding which
surgical technique should be used in order to properly cal-
culate the ablation depth, thus avoiding corneal ectasia.
In order to prevent complications and obtain desired
visual quality, the flap construction and manipulation is
also critical.
We classify complications as follows:
• Intraoperative: Related to flap construction and
related to ablation
• Postoperative
Intraoperative Complications
It is very important to control the surgical environment,
especially with regard to humidity and temperature, in
order to have the equipment to function properly. For pre-
dictable and exact results, these parameters have to be
kept stable.
Before beginning LASIK, calibration, alignment, beam
profiles, and other parameters have to be checked accord-
ing to each equipment’s recommendations.
Epithelial Care
It is very important to take care of it because, due to its
high sensitivity, any erosion or excessive dehydration will
produce pain. Anesthesia and dye used to mark the cornea
before the procedure must be handled carefully to avoid
chemical epithelial damage. As we perform bilateral
LASIK, our principle issue relates to keeping the epitheli-
um moist.
Flap Construction
During this stage some complications can appear, lead-
ing to stopping the flap construction short, which in some
cases can leave corneal scars that decrease the quality and
quantity of visual acuity.
To create a flap without complications we have to cor-
rectly assemble the microkeratome (MK) and pass the ker-
 Bioptics 185

Case Report: Abnormal Pigment Dispersion

Sex: Female
Age: 42 years old
Rx UCVA BCVA
OD -27.00 Count fingers Count fingers
OS -25.00 20/60 20/50

Implant Date 11/1999

ICL Power OS: -15.50 D, Size 12.5 mm, Vault Type 3, IOP 14 mmHg, Pigment ±
ICL Power OD: -15.00 D, Size 12.5mm, 24 Hour follow up, Vault Type 4, IOP 45mm Hg, Pigment ++++
The pupil measured 4.5 mm and was not reactive. Slightly open iridotomies. We prescribed medical treatment
for glaucoma without relief, so we performed a surgical iridectomy and ICL explantation because of the large amount
of pigment dispersion. The other eye did not present any complication. Four months later we decided to perform a
phacoemulsification with IOL in order to correct the refractive error. At present time the IOP is normal without
medical treatment and UCVA is 20/40.

atome without obstacles and with adequate suction. If the
IOP does not increase as needed, it is necessary to remove
the suction and check the ring, observe the conjunctival
status to make sure it is not excessively boggy, and pro-
ceed again. The eyelash protection with adhesive tape will
help to avoid problems related to the suction ring or with
the MK passage.11 In our patients we have not observed
retinal complications associated with the IOP increase that
occurs with the suction.12
Button Hole
Possible causes for this situation are poor suction dur-
ing flap performance, patients that present with steep
corneas, blade-related problems, or MK malfunction. In
this case we act the same way, aborting the surgery, trying
to reposition the flap in order to avoid abnormal epithelial
ingrowth that would add complications to the case, and
perform a new keratectomy 3 or 4 months later.
Irregular Bed
Irregular MK passage provokes this special case. The
consequence can be visual acuity loss in quality and quan-
tity. This normally happens because of dull areas in the
blade or loss of suction. In order to avoid this complica-
tion, it is important to check the equipment and handle
blades properly.
We suggest that the ablation not be performed and to
construct a new flap with a new surgery 3 or 4 months
later.
Free Cap
The complete flap cut can happen for many reasons,
such as MK stop failure, flap thinness, loss of suction, flat
cornea, etc. If this situation occurs, we have to keep the
cap wet with the epithelium side down on the conjuncti-
va, proceed with the ablation, and then reposition it cor-
rectly. It is very important to use clear marks before per-
forming the flap, a maneuver that will help to put the cap
in the right place. We have to check the flap adhesion in
order to avoid displacement or loss in the postoperative
period. If the adherence is not achieved, it is necessary to
suture the flap and remove the stitches as soon as possible.
We place a therapeutic contact lens and occlude the eye
with adhesive tape in order to prevent this severe compli-
cation.12
Ablation Complications
Decentered Ablations
Before starting the ablation, we have to check that the
laser beam is lined up with the pupillary center and control
its position during the entire session. Some anxious
patients are not able to cooperate with fixation, so the cen-
tration can be lost. This also happens in very long proce-
dures. The latest eye tracker generations used with per-
sonalized ablation equipment are highly reliable, however.
Symptoms associated with decentration could be visual
disturbances around lights, glare, monocular diplopia, etc.
The treatment consists basically in preventing this compli-
cation, but in cases where it still occurs we can prescribe
dilute pilocarpine in order to diminish the symptoms.
Irregular astigmatism can be induced if decentration is sig-
nificant. In these cases we suggest the use of glasses but in
some cases we can only provide some comfort to the
patient prescribing flexible or rigid contact lenses.
Central Island
This serious problem is due to an irregular ablation in
the center of the cornea, provoking a clearly detectable
“step” in the topography. There are many probable and
186 Chapter 18
proved causes that can provoke central islands. We can
mention liquid accumulation during the ablation caused by
insufficient drying. Another theory is vortex fog, which
interferes with the laser beam in the corneal center. Some
equipment has a vacuum system that prevents vortex fog.
Another cause is the shock wave that generates liquid
accumulation in the center of the surgical bed. This situa-
tion is more frequent with the broad beam lasers compared
with scanning systems that produce less intense acoustic
shocks. Equipment manufacturers are aware of this condi-
tion, so they have added a central island treatment pro-
gram in order to prevent this kind of complication.
Clinically, this situation provokes bad quality vision,
visual acuity loss, ghosting, etc. Diagnosis is based on clin-
ical examination and topography that shows a central step
in the ablation zone.
The best treatment for this complication is prevention.
Spontaneous resolution of central islands induced by
LASIK takes a long time. When performing the ablation,
it can be interrupted as many times as necessary to dry the
area to reduce the incidence of this complication.
Differential diagnosis must be done to distinguish this
from ectasia. Topographically, ectasia is bigger and is pro-
gressive, and visual damage is usually worse with ectasia.
Modern lasers, such as flying spot beam lasers and rotating
slit beam lasers, do not create central islands. In order to
avoid this complication, broad beam lasers have currently
improved their software.
Postoperative Complications
In early visits after surgery the most frequent complica-
tions are dry eye or folds in the flap. Concerning folds, we
can divide them into two groups: those related to the abla-
tion and displacements folds. The first group is caused by
deep ablations when corrections performed are very high
(exceptional in cases of bioptics).13 One of the reasons we
utilize bioptics is to prevent these microfolds, which alter
visual quantity and quality. These folds have no concrete
solution. The second group is produced by flap displace-
ment and has to be treated immediately. The treatment
consists of lifting the flap, refloating it into place, and
repositioning it properly.
Epithelial Ingrowth
This complication appears more frequently in retreated
patients when the previous flap is lifted. We can also
observe this complication in a primary procedure where it
is caused by cells brought centrally by the MK.
The abnormal ingrowth is provoked by the presence of
cells in the surgical bed that stay connected with flap bor-
der cells. By carefully manipulating the epithelium, we
prevent damaged areas that can provide an entrance for
epithelial cells to implant in the interface.
Clinically, a few weeks after LASIK, epithelial ingrowth
can be observed as an interface transparency loss followed
by cystic lesions and a variable size and amount of epithe-
lial pearls.
Tear film changes, foreign body sensation, and irregu-
lar astigmatism can appear if those lesions are central or
keep on growing. Instead, if they are small and peripheral
and symptoms are not present, then they can be observed
and do not require treatment.
Treatment consists of lifting the flap to clean the surgi-
cal bed and interface with a surgical sponge and trying to
remove the deposits and membranes. You must always
move the deposits and membranes toward the periphery.
A cleaning of the interface plus phototherapeutic kera-
tectomy may be needed in cases that do not improve after
the first procedure. The laser kills epithelial cells, avoiding
posterior ingrowth.
Sometimes epithelial ingrowth can become a melt with
flap tissue destruction. This situation is clearly severe,
leading to great vision disturbances, dry eye, etc. Cases
presenting with a melt must be strongly and carefully
treated in order to avoid greater flap damage or associated
infections. The flap has to be lifted to clean the whole
necrotic tissue. After repositioning the flap, we place a
contact lens and patch the eye to assure that there are no
flap displacements. We also prescribe antibiotics and
hydrating drops.
Our best recommendation is to prevent complications.
The surgeon learning curve in flap management, especial-
ly in retreatment, dramatically diminishes the appearance
of complications.
Nonspecific Diffuse Intralamellar Keratitis
Smith and Maloney14 described this complication in
1998 in patients who had LASIK.
There are many theories about this nonspecific inflam-
mation that appears in the early postoperative period.
Probable causes could be toxic, immunologic, or reactive
to the presence of foreign elements, such as red cells, mei-
bomian secretion, microkeratome oil residues, etc.
When the infiltration is intense, the patient presents in
the early postoperative period with variable pain, blurry
vision, red eye, epiphora, photophobia, etc.
Microscopically, there is a diffuse intralamellar infiltration
of different grades. In a few days it becomes concentric,
leaving a central scar similar to haze with central micro-
folds. This situation finally induces a hyperopic shift.
Apparently, the most severe infiltrates are those caused
by microkeratome oil, so to prevent this complication it is
very important to practice proper instrument care and
maintenance. We believe that these deposits cause intense
and severe diffuse intralamellar keratitis (DIK). Other less
important infiltrates are those caused by nonspecific and
nontoxic agents, and they resolve without consequences.

We recommend augmenting the dose of topical
steroids and antibiotic prophylaxis for treatment. In some
extreme cases it can be useful to lift and wash the interface.
Interface Fluid and Corneal Edema
Many authors have described this complication recently
after a DIK.15-17 It can appear in many situations and if not
recognized, the situation can become worse. The patient
presents with a progressive decrease in visual acuity.
Biomicroscopically, liquid accumulation in the interface can
be observed. Applanation tension measured over the flap
seems to be normal, but if taken peripheral to it or digitally,
it will appear elevated. The cause for this accumulation is not
clear; the endothelial cell function is normal and there is no
presence of cells or deposits attracting liquid. It is proven
that the syndrome disappears with clinical and microscopic
improvement when the ocular tension decreases.17
CONCLUSIONS
Our results show that bioptics is a safe, predictable, and
stable technique. Proper patient selection is very impor-
tant, as is evaluating not only the refraction but also pre-
operative studies.
Bioptics by itself improves UCVA and BCVA, and by
adding custom ablation, we can ameliorate their visual
symptoms even better, keeping in mind that this group of
patients usually present with only fair preoperative BCVA.
As bioptics has extended, we have also observed good
results in other groups of cases, such as pseudophakic eyes.
In these patients, no additional complications associated
with age or previous capsulotomy have been detected.
An important topic to consider is the low rate of com-
plications related to both techniques, and the negligible
incidence associated with their combination. We have not
observed any phakic or pseudophakic patient with an inci-
sion that opens nor IOL luxation into the anterior cham-
ber after the suction.
Although the majority of patients present with high
myopia, we have not observed an increased incidence of
retinal detachment or other retinal diseases.
We believe that using a proper technique, ICL power
lower than -15.5 D, V4 model, and a careful follow-up, we
can almost assure excellent results for patients that present
with a real difficulty in their lives, related to high refractive
defects.
Bioptics 187
REFERENCES
1. Zaldivar R, Oscherow S, Ricur S. Implantable contact lens.
In: Fine H, ed. Clear Corneal Lens Surgery. Thorofare, NJ:
SLACK Incorporated; 1998:286-324.
2. Zaldivar R, Davidorf J, Oscherow S, et al. Combined poste-
rior chamber phakic intraocular lens and laser in situ ker-
atomileusis: bioptics for extreme myopia. J Refract Surg.
1999;15:299-308.
3. Zaldivar R, Davidorf JM, Oscherow S. Posterior chamber
phakic intraocular lens implantation for extreme myopia.
J Refract Surg. 1998;14:294-305.
4. Machat JJ. Excimer Laser Refractive Surgery: Practice, and
Principles. Thorofare, NJ: SLACK Incorporated; 1996.
5. Guell JL, Muller A. Laser in situ keratomileusis (LASIK) for
myopia from -7 D to -18D. J Refract Surg. 1996;12:222-228.
6. Salah T, Waring GO, El Maghraby A, Moadel K, Grimm SB.
Excimer laser in situ keratomileusis under corneal flap for
myopia of 2 to 20 D. Am J Ophthalmol. 1996;121:143-155.
7. Zaldivar R, Davidorf JM, Oscherow S. Laser in situ ker-
atomileusis for myopia from -5.50 to -11.00 D with astig-
matism. J Refract Surg. 1998;14:19-25.
8. Zaldivar R, Davidorf JM, Shultz MC, Oscherow S. LASIK
for low myopia and astigmatism with a scanning spot
excimer laser. J Refract Surg. 1997;13(7):614-619.
9. Guell J. The adjustable refractive surgery concept (ARS).
J Refract Surg. 1998;14:271.
10. Zaldivar R. Personal LASIK technique. In: Machat J, Slade,
Probst L, eds. The Art of LASIK. Thorofare, NJ: SLACK
Incorporated; 1999:217-222.
11. Ambrosio R, Wilson, S. Complications of laser in situ ker-
atomileusis: etiology, prevention and treatment. J Refract
Surg. 2001;17(3):350-379.
12. Zaldivar R, Oscherow S, Ricur G. Complex postoperative
flap problems. In: Probst L, ed. Complex Cases with LASIK.
Thorofare, NJ: SLACK Incorporated; 2000:339.
13. Zaldivar R, Oscherow S, Ricur G. Bioptics. In: Probst L, ed.
Complex Cases with LASIK. Thorofare, NJ: SLACK
Incorporated; 2000:504-507.
14. Smith RJ, Maloney RK. Diffuse lamellar keratitis.
Ophthalmology. 1998;105:1721-1726.
15. Lyle W, Jin G. Interface fluid associated with diffuse lamel-
lar keratitis and epithelial ingrowth after laser in situ ker-
atomileusis. J Cataract Refract Surg. 1999;25:1009-1012.
16. Rehany U, Bersudsky V, Rumelt S. Paradoxical hypotony
after laser in situ keratomileusis. J Cataract Refract Surg.
2000;26(12):1823-1826.
17. Porterllina W, Kuchenbuk M, Nakano K. Interface fluid and
diffuse corneal edema after LASIK. J Refract Surg.
2001;17:192-195.

Refractive Lens Exchange
Mark Packer, MD; Richard S. Hoffman, MD; and I. Howard Fine, MD
Refractive lens exchange is becoming a more popular
method of refractive surgery in the presbyopic patient.
The limitations of keratorefractive surgery have led to a
resurgence of lens exchange surgery for patients with pre-
scriptions outside the limits of corneal refractive proce-
dures in addition to patients with routine refractive errors
requesting a surgical procedure to achieve emmetropia and
also address presbyopia. Phakic intraocular lenses (IOLs)
do not stop the process of presbyopia, the increase in
lenticular spherical aberration, or the development of lens
opacities. In patients who already demonstrate early lens
changes, refractive lens exchange can address both the
refractive error and the natural lens-induced aberrations.
Attention to detail in regards to proper patient selection,
preoperative measurements, intraoperative technique, and
postoperative management will ultimately result in excel-
lent outcomes and improved patient acceptance of this
effective technique.
As the outcomes of cataract surgery continue to
improve, the use of lens surgery as a refractive modality in
patients without cataracts has increased in popularity. The
removal of the crystalline lens and replacement with a
pseudophakic lens for the purposes of reducing or elimi-
nating refractive errors has been labeled with many titles.
These titles include clear lensectomy,1,2 clear lens pha-
coemulsification,3 clear lens replacement, clear lens
extraction,4-12 clear lens exchange, presbyopic lens
exchange, and refractive lens exchange. The term refrac-
tive lens exchange appears to best describe the technique
of removing the crystalline lens and replacing it with a
pseudophakic lens in a patient of any age for the purpose
19 Chapter
of reducing or eliminating refractive errors, optical aberra-
tions, and/or addressing presbyopia.
MULTIFOCAL LENSES
Perhaps the greatest catalyst for the resurgence of
refractive lens exchange has been the development of mul-
tifocal lens technology. Historically, multifocal IOLs have
been developed and investigated for decades. One of the
first multifocal IOL designs to be investigated in the
United States was the center-surround IOL, now under the
name NuVue (Bausch & Lomb Surgical, Rochester, NY).
This lens had a central near add surrounded by a distance-
powered periphery. Other IOL designs include the 3M
diffractive multifocal IOL (3M Corporation, St. Paul,
Minn), which has been acquired, redesigned, and format-
ted for the foldable AcrySof acrylic IOL (Alcon
Laboratories, Dallas, Tex) (Figure 19-1). Pharmacia has
also designed a diffractive multifocal IOL, the CeeOn
811E (Groningen, Netherlands), that has been implanted
extensively outside of the United States. Alcon,
Pharmacia, and Storz have also investigated three-zone
refractive multifocal IOLs that have a central distant com-
ponent surrounded at various distances by a near annu-
lus.13
The only multifocal IOL approved for general use in
the United States is the Array (Advanced Medical Optics
[AMO], Irvine, Calif). The Array is a zonal progressive
IOL with five concentric zones on the anterior surface
(Figure 19-2). Zones 1, 3, and 5 are distance dominant
zones, while zones 2 and 4 are near dominant. The lens
190 Chapter 19
Figure 19-1. The Alcon sin-
gle-piece ReSTOR (photo
courtesy of Alcon, Inc).
Figure 19-2B. The AMO Array foldable silicone multifocal
IOL (courtesy of Advanced Medical Optics).
has an aspherical component and thus each zone repeats
the entire refractive sequence corresponding to distance,
intermediate, and near foci. This results in vision over a
range of distances. The lens uses 100% of the incoming
available light and is weighted for optimum light distribu-
tion. With typical pupil sizes, approximately half of the
light is distributed for distance, one-third for near vision,
and the remainder for intermediate vision. The lens uti-
lizes continuous surface construction and consequently,
there is no loss of light through diffraction and no degra-
dation of image quality as a result of surface discontinu-
ities.14 The lens has a foldable silicone optic that is 6.0 mm
in diameter with haptics made of polymethylmethacrylate
and a haptic diameter of 13 mm. The lens can be inserted
through a clear corneal or scleral tunnel incision that is 2.8
mm wide, utilizing the Unfolder injector system manufac-
tured by AMO.
Figure 19-2A. The AMO
Array foldable silicone multi-
focal IOL (courtesy of
Advanced Medical Optics).
CLINICAL RESULTS
The efficacy of zonal progressive multifocal technolo-
gy has been documented in many clinical studies. Early
studies of the one-piece Array documented a larger per-
centage of patients who were able to read J2 print after
undergoing multifocal lens implantation compared to
patients with monofocal implants.15-17 Similar results have
been documented for the foldable Array.18 Clinical trials
comparing multifocal lens implantation compared to
monofocal lens implantation in the same patient also
revealed improved intermediate and near vision in the
multifocal eye compared to the monofocal eye.19,20
CONTRAST SENSITIVITY
Many studies have evaluated both the objective and
subjective qualities of contrast sensitivity, stereoacuity,
glare disability, and photic phenomena following implan-
tation of multifocal IOLs. Refractive multifocal IOLs, such
as the Array, have been found to be superior to diffractive
multifocal IOLs by demonstrating better contrast sensitiv-
ity and less glare disability.21 However, more recent
reports comparing refractive and diffractive IOLs have
revealed similar qualities for distance vision evaluated by
modulation transfer functions but superior near vision for
the diffractive lens.22
In regards to contrast sensitivity testing, the Array has
been shown to produce a small amount of contrast sensi-
tivity loss equivalent to the loss of one line of visual acuity
at the 11% contrast level using Regan contrast sensitivity
charts.16 This loss of contrast sensitivity at low levels of
contrast was only present when the Array was placed
monocularly and was not demonstrated with bilateral

Figure 19-3A. Clinical results of bilateral Array implantation fol-
lowing refractive lens exchange.
placement and binocular testing.23 Regan testing is per-
haps not as reliable as sine wave grating tests, which eval-
uate a broader range of spatial frequencies. Utilizing sine
wave grating testing, reduced contrast sensitivity was
found in eyes implanted with the Array in the lower spa-
tial frequencies compared to monofocal lenses when a
halogen glare source was absent. When a moderate glare
source was introduced, no significant difference in con-
trast sensitivity between the multifocal or monofocal lens-
es was observed.24 However, recent reports have demon-
strated a reduction in tritan color contrast sensitivity func-
tion in refractive multifocal IOLs compared to monofocal
lenses under conditions of glare. These differences were
significant for distance vision in the lower spatial frequen-
cies and for near in the low and middle spatial frequen-
cies.25 A new aspheric multifocal IOL, the Progress 3
(Domilens Laboratories, Lyon, France), also demonstrated
significantly lower mean contrast sensitivity with the Pelli-
Robson chart compared to monofocal IOLs.26
Ultimately, these contrast sensitivity tests reveal that,
in order to deliver multiple foci on the retina, there is
always some loss of efficiency with multifocal IOLs when
compared to monofocal IOLs. However, contrast sensitiv-
ity loss, random-dot stereopsis, and aniseikonia can be
improved when multifocal IOLs are placed bilaterally
compared to unilateral implants.27 A recent publication
evaluating a three-zone refractive multifocal IOL demon-
strated improved stereopsis, less aniseikonia, and greater
likelihood for spectacle independence with bilateral
implantation compared to unilateral implantation.28
PHOTIC PHENOMENA
One of the potential drawbacks of the Array multifocal
lens has been the potential for an appreciation of halos
Refractive Lens Exchange 191
Figure 19-3B. Clinical results of bilateral Array implantation fol-
lowing refractive lens exchange.
around point sources of light at night in the early weeks
and months following surgery.29-31 Most patients will
learn to disregard these halos with time, and bilateral
implantation appears to improve these subjective symp-
toms. Concerns about the visual function of patients at
night have been allayed by a driving simulation study in
which bilateral Array multifocal patients performed only
slightly worse than patients with bilateral monofocal
IOLs. The results indicated no consistent difference in
driving performance and safety between the two groups.32
In a study by Javitt et al, 41% percent of bilateral Array
subjects were found to never require spectacles compared
to 11.7% of monofocal controls. Overall, subjects with
bilateral Array IOLs reported better overall vision, less
limitation in visual function, and less use of spectacles than
monofocal controls.33
REFRACTIVE LENS EXCHANGE
A recent study reviewed the clinical results of bilateral-
ly implanted Array multifocal lens implants in refractive
lens exchange patients.34 A total of 68 eyes were evaluat-
ed, comprising 32 bilateral and 4 unilateral Array implan-
tations. One hundred percent of patients undergoing bilat-
eral refractive lens exchange achieved binocular visual acu-
ity of 20/40 and J5 or better, measured 1 to 3 months post-
operatively. Over 90% achieved uncorrected binocular
visual acuity of 20/30 and J4 or better, and nearly 60%
achieved uncorrected binocular visual acuity of 20/25 and
J3 or better (Figure 19-3). This study included patients
with preoperative spherical equivalents between 7 diopters
(D) of myopia and 7 D of hyperopia with the majority of
patients having preoperative spherical equivalents
between plano and +2.50. Excellent lens power determi-
nations and refractive results were achieved (Figure 19-4).
192 Chapter 19
Figure 19-4. Scattergram demonstrating
reduction of spherical equivalent in refrac-
tive lens exchange eyes.
PATIENT SELECTION
Specific guidelines with respect to the selection of can-
didates and surgical strategies that enhance outcomes with
this IOL have been developed. AMO recommends using
the Array multifocal IOL for bilateral cataract patients
whose surgery is uncomplicated and whose personality is
such that they are not likely to fixate on the presence of
minor visual aberrations, such as halos around lights.
There is obviously a broad range of patients who would be
acceptable candidates. Relative or absolute contraindica-
tions include the presence of ocular pathologies, other
than cataracts, that may degrade image formation or may
be associated with less than adequate visual function post-
operatively despite visual improvement following surgery.
Pre-existing ocular pathologies, which are frequently
looked upon as relative contraindications, include age-
related macular degeneration, uncontrolled diabetes or
diabetic retinopathy, uncontrolled glaucoma, recurrent
inflammatory eye disease, retinal detachment risk, corneal
disease, or previous keratorefractive surgery. However, a
recent study has revealed comparable distance acuity out-
comes in Array and monofocal patients with concurrent
eye disease, such as macular degeneration, glaucoma, and
diabetic retinopathy.35
Utilization of these lenses in patients who complain
excessively, are highly introspective, or obsess over body
image and symptoms should be avoided. In addition, con-
servative use of this lens is recommended when evaluating
patients with occupations that include frequent night driv-
ing and occupations that put high demands on vision and
near work, such as engineers and architects. Such patients
need to demonstrate a strong desire for relative spectacle
independence in order to be considered for a refractive
lens exchange with Array implantation. Recent publica-
tions have found multifocal lens implantation to be a cost-
effective option for low-income patients and patients in
developing countries where the added expense of near
vision spectacles would be prohibitive.36,37 Additionally,
multifocal IOL implantation was found to be a viable
option for pediatric cataract patients, thus eliminating
spectacle dependence in this susceptible group of
patients.38
Finally, the patient’s axial length and risk for retinal
detachment or other retinal complications should be con-
sidered. Although there have been many publications doc-
umenting a low rate of complications in highly myopic
clear lens extractions,1,3,8-10 others have warned of signif-
icant long-term risks of retinal complications despite pro-
phylactic treatment.39,40 With this in mind, other phakic
refractive modalities should be considered in extremely
high myopes. If refractive lens exchange is performed in
these patients, extensive informed consent regarding the
long-term risks for retinal complications should naturally
occur preoperatively.
PREOPERATIVE MEASUREMENTS
The most important assessment for successful multifo-
cal lens use, other than patient selection, involves precise
preoperative measurements of axial length in addition to
accurate lens power calculations. There are some practi-
tioners who feel that immersion biometry is necessary for
accurate axial length determination. However, applana-
tion techniques in combination with the Holladay 2 for-
mula yield accurate and consistent results with greater
patient convenience and less technician time. A newer
device now available, the Zeiss IOLMaster (Carl Zeiss
Meditec, Dublin, Calif), is a combined biometry instru-
ment for noncontact optical measurements of axial length,

corneal curvature, and anterior chamber depth that yields
extremely accurate and efficient measurements with mini-
mal patient inconvenience. The axial length measurement
is based on an interference-optical method termed partial
coherence interferometry and measurements are claimed
to be compatible with acoustic immersion measurements
and accurate to within 30 ␮m. Regardless of the technique
being used to measure axial length, it is important that the
surgeon use biometry that he or she feels yields the most
consistent and accurate results.
When determining lens power calculations, the
Holladay 2 formula takes into account disparities in ante-
rior segment and axial lengths by adding the white-to-
white corneal diameter and lens thickness into the formu-
la. Addition of these variables helps predict the exact posi-
tion of the IOL in the eye and has improved refractive pre-
dictability. The SRK T formula can be used as a final check
in the lens power assessment. For eyes with less than
22 mm of axial length, the Hoffer Q formula should be uti-
lized for comparative purposes.
SURGICAL TECHNIQUE
The multifocal Array works best when the final postop-
erative refraction has less than 1 D of astigmatism. Thus, it
is very important that incision construction be appropriate
with respect to size and location. A clear corneal incision
at the temporal periphery that is 3 mm or less in width and
2 mm long is highly recommended.41 The surgeon must
also be able to utilize one of the many modalities for
addressing preoperative astigmatism. Although both T and
arcuate keratotomies at the 7 mm optical zone can be uti-
lized, there is an increasing trend favoring 600 ␮m deep
limbal relaxing incisions for the reduction or elimination
of pre-existing astigmatism.42,43
In preparation for phacoemulsification, hydrodelin-
eation and cortical cleaving hydrodissection are important
because they facilitate lens disassembly and complete cor-
tical cleanup.44 Complete and fastidious cortical cleanup
will hopefully reduce the incidence of posterior capsule
opacification whose presence, even in very small amounts,
will inordinately degrade the visual acuity in Array patients.
It is because of this phenomenon that patients implanted
with Array lenses will require neodymium:yttrium-alu-
minum-garnet (Nd:YAG) laser posterior capsulotomies ear-
lier than patients implanted with monofocal IOLs.
COMPLICATIONS MANAGEMENT
When intraoperative complications develop, they must
be handled precisely and appropriately. In situations in
which the first eye has already had an Array implanted,
complications management must be directed toward find-
ing any possible means of implanting an Array in the sec-
Refractive Lens Exchange 193
ond eye. Under most circumstances, capsule rupture will
still allow for implantation of an Array as long as there is
an intact capsulorrhexis. Under these circumstances, the
lens haptics are implanted in the sulcus and the optic is
prolapsed posteriorly through the anterior capsulorrhexis.
This is facilitated by a capsulorrhexis that is slightly small-
er than the diameter of the optic in order to capture the
optic in essentially an “in-the-bag” location.
It is important to avoid iris trauma because the pupil
size and shape may impact the visual function of a multi-
focal IOL postoperatively. If the pupil is less than 2.5 mm,
there may be an impairment of near visual acuity due to
the location of the rings serving near visual acuity.45 For
patients with small postoperative pupil diameters affecting
near vision, a mydriatic pupilloplasty can be successfully
performed with the Argon laser.46 Enlargement of the
pupil will expose the near dominant rings of the multifocal
IOL and restore near vision in most patients.
POSTOPERATIVE COURSE
If patients are unduly bothered by photic phenomena,
such as halos and glare, these symptoms can be alleviated
with various techniques. Weak pilocarpine at a concentra-
tion of 0.125% or weaker will constrict the pupil to a diam-
eter that will usually lessen the severity of halos without sig-
nificantly affecting near visual acuity. Similarly, brimoni-
dine tartrate ophthalmic solution 0.2% has been shown to
reduce pupil size under scotopic conditions47 and can also
be administered in an attempt to reduce halo and glare
symptoms. Another approach involves the use of over-
minused spectacles in order to push the secondary focal
point behind the retina and thus lessen the effect of image
blur from multiple images in front of the retina.48 Polarized
lenses have also been found to be helpful in reducing phot-
ic phenomena. Perhaps the most important technique is the
implantation of bilateral Array lenses as close in time as pos-
sible in order to allow patients the ability to use the lenses
together, which appears to allow for improved binocular
distance and near vision compared to monocular acuity.
Finally, most patients report that halos improve or disappear
with the passage of several weeks to months.
ACCOMMODATIVE
INTRAOCULAR LENSES
The inspiration for an IOL with axial movement began
with several observations made during the 1980s. In 1986,
Spencer Thornton published evidence of anterior move-
ment of a three-piece loop lens. With the administration
of pilocarpine, the lens moved 0.5 mm forward when com-
pared to its position under atropine.49 At about the same
time, Jackson Coleman demonstrated increased intravitre-
194 Chapter 19
Figure 19-5. The C & C
Vision CrystaLens (cour-
tesy of C & C Vision).
al pressure and decreased anterior chamber pressure during
electrical stimulation of the ciliary body in primates, sug-
gesting that a pressure differential occurs concomitantly
with axial movement of the lens during accommodation.50
Coleman’s observation provided a potential explanation
for the occurrence of axial movement of an IOL during
accommodative effort. Meanwhile, Stuart Cumming inves-
tigated the ability of some patients to read well through
plate haptic IOLs with their distance correction in dim
light. He showed an average of 0.7 mm of anterior move-
ment of plate haptic IOLs with pilocarpine compared to a
cycloplegic agent. Thus, he began the development of an
IOL designed to maximize axial movement and restore
accommodation to the pseudophakic patient.
Over 9 years, Cumming, while working with Jochen
Kammann in Dortmund, Germany, investigated seven
IOL designs. While the first six designs all demonstrated
evidence of axial movement, they also tended to dislocate
anteriorly. The second design, for example, displayed
average accommodative amplitude of 2.06 D at 25
months. Two of 24 lenses implanted subsequently dislo-
cated. This design also demonstrated retention of accom-
modation after Nd:YAG capsulotomy.
The seventh and current design of this axial movement
IOL is the AT-45 CrystaLens, produced by C & C Vision
(Mission Viejo, Calif). The lens features hinged haptics
with a 4.5-mm silicone optic and a 12.5-mm overall diam-
eter. Polyamide loops adhere to the capsule and prevent
dislocation (Figure 19-5).
The Oregon Eye Institute has participated in the US
Food and Drug Administration (FDA) monitored clinical
investigation of the CrystaLens in the United States. Since
May 2000, we have implanted a total of 96 eyes, nearly a
quarter of all eyes implanted in the study. We have found
overall excellent results and present here data from 82
patients who are at least 1 month postoperative.
Briefly, our preoperative evaluation has included immer-
sion A-scan ultrasonography with the Quantel Axis II
(Quantel Medical, Bozeman, Mont) and Prager shell (ESI
Inc, Plymouth, Minn), as well as partial coherence interfer-
ometry with the IOLMaster. We have employed computer-
ized corneal topography to improve keratometry values and
the Holladay II, SRKT, and Hoffer Q IOL calculation for-
mulae. Patients with greater than 1.00 D corneal astigmatism
have been excluded from the study. For bilateral implanta-
tion we have targeted -0.50 D spherical equivalent in the first
eye and planospherical equivalent in the second eye.
Key elements of our surgical technique include a
2.5-mm temporal clear corneal incision, which is enlarged
to 3.5 mm for implantation. A round, centered 4.0-mm
capsulorrhexis insures in-the-bag fixation of the IOL optic.
Atropine 1% solution is administered at the conclusion of
the case and at the first postoperative visit to insure that
the IOL will settle posteriorly in the capsule.
In reporting results we use the terms distance-corrected
near vision and distance-corrected intermediate vision.
Distance-corrected near vision is the visual acuity meas-
ured with the ETDRS reading card at 16 inches, using the
best spectacle correction for distance as measured by man-
ifest refraction. Distance-corrected intermediate vision is
measured in a similar manner at 32 inches.
With 100% of 82 eyes demonstrating best-corrected
distance acuity of 20/40 or better and 91.5% enjoying
uncorrected distance acuity of 20/40 or better, 86.6%
exhibit uncorrected near vision of J3 or better. Even a
greater percentage, 92.7%, exhibit distance-corrected near
vision of J3 or better. For 27 eyes measured 11 to 15
months postoperatively, 85.0% demonstrate uncorrected
distance vision of 20/40 or better. At the same time, 92.5%
demonstrate J3 or better uncorrected near vision, and
96.3% demonstrate J3 or better distance-corrected near
vision.
One of the striking features of this data—the improve-
ment of near vision with distance correction—demon-
strates the accommodative nature of this IOL technology.
Distance correction effectively removes corneal astigma-
tism and myopia as possible pseudoaccommodative mech-
anisms. As a historical comparison, published data have
demonstrated that only 48% of patients with a monofocal
IOL can read J3 or better with best distance correction.51
When binocularity is taken into account, the visual
results appear even more impressive. One hundred percent
of 24 patients with binocular implantation achieved 20/30
or better at distance without correction. One hundred per-
cent also read J3 or better at near with or without distance
correction. The distance corrected intermediate vision is
generally better than the distance-corrected near vision.
For these patients, 100% read J2 at 32 inches with their
distance correction.

Figure 19-6. Binocular uncorrected distance, intermediate, and
near visual acuity with the C & C Vision CrystaLens.
When uncorrected distance, intermediate, and near
visual acuity are measured, we find that 100% of these
patients can read 20/30 and J3, while 83% can read 20/25
and J2 and 70.8% can read 20/20 and J1 (Figure 19-6). As
a historical comparison, our series of refractive lens
exchange patients implanted with a multifocal IOL
demonstrated 59.3% uncorrected binocular visual acuity
of 20/25 and J3, while 90.6% demonstrate uncorrected
binocular visual acuity of 20/30 and J4.52
Contrast sensitivity testing has shown that the AT-45
CrystaLens exhibits quality of vision comparable to stan-
dard monofocal IOLs. We have not found any increase in
patient complaints about glare and unwanted optical
effects with the CrystaLens as compared to standard
monofocal IOLs. Although initially the 4.5-mm optic
caused some concerns about quality of vision, these con-
cerns have been eliminated as we have gained experience
using this IOL. Also, in the few patients who have under-
gone Nd:YAG laser capsulotomy, we have found that the
ability to see well at both distance and near has been
retained.
We have found the CrystaLens accommodative IOL to
represent exciting new technology with immediate bene-
fits for both patients and surgeons. The high proportion of
patients with excellent uncorrected distance, intermediate,
and near vision means increased spectacle independence
and improved quality of life. Accommodating IOL tech-
nology offers a new option for refractive lens exchange.
Careful preoperative evaluation, including accurate biom-
etry and lens power calculation, remains critical to this
success. New technology always demands more from the
surgeon. In this case, the benefits well repay the extra
effort.
Refractive Lens Exchange 195
CONCLUSIONS
Thanks to the success of the excimer laser, refractive
surgery is increasing in popularity throughout the world.
Corneal refractive surgery, however, has its limitations.
Patients with severe degrees of myopia and hyperopia are
poor candidates for excimer laser surgery, and presbyopes
must contend with reading glasses or monovision to
address their near visual needs. Phakic IOLs are limited to
patients with deep anterior chambers, which makes them
of limited utility in hyperopes. Additionally, patients in
the presbyopic age range or those developing early
cataracts may be better served with the one-step process of
refractive lens exchange. The rapid recovery and astigmat-
ically neutral incisions currently being utilized for modern
cataract surgery have allowed this procedure to be used
with greater predictability for refractive lens exchanges in
patients who are otherwise not suffering from visually sig-
nificant cataracts.
Successful integration of refractive lens exchanges into
the general ophthalmologist’s practice is fairly straight for-
ward since most surgeons are currently performing small
incision cataract surgery for their cataract patients.
Although any style of foldable IOL can be used for lens
exchanges, multifocal IOLs currently offer the best option
for addressing both the elimination of refractive errors and
presbyopia. Refractive lens exchange with multifocal lens
technology is not for every patient considering refractive
surgery but does offer substantial benefits, especially in
high hyperopes, presbyopes, and patients with borderline
or soon to be clinically significant cataracts who are
requesting refractive surgery.
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9. Lyle WA, Jin GJ. Clear lens extraction to correct hyperopia.
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12. Lyle WA, Jin GJ. Clear lens extraction for the correction of
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domized, double-masked comparison of a zonal-progressive
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17. Negishi K, Nagamoto T, Hara E, et al. Clinical evaluation
of a five-zone refractive multifocal intraocular lens.
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18. Brydon KW, Tokarewicz AC, Nichols BD. AMO Array
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19. Vaquero-Ruano M, Encinas JL, Millan I, et al. AMO Array
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20. Steinert RF, Aker BL, Trentacost DJ, et al. A prospective
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cone intraocular lens and a monofocal intraocular lens.
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22. Pieh S, Marvan P, Lackner B, et al. Quantitative perform-
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23. Arens B, Freudenthaler N, Quentin CD. Binocular function
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24. Schmitz S, Dick HB, Krummenauer F, et al. Contrast sensi-
tivity and glare disability by halogen light after monofocal
and multifocal lens implantation. Br J Ophthalmol.
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25. Pieh S, Hanselmayer G, Lackner B, et al. Tritan colour con-
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26. Kamlesh S, Dadeya S, Kaushik S. Contrast sensitivity and
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197-201.
27. Haring G, Gronemeyer A, Hedderich J, et al. Stereoacuity
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28. Shoji N, Shimizu K. Binocular function of the patient with
the refractive multifocal intraocular lens. J Cataract Refract
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29. Dick HB, Krummenauer F, Schwenn O, et al. Objective and
subjective evaluation of photic phenomena after monofocal
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30. Haring G, Dick HB, Krummenauer F, et al. Subjective phot-
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33. Javitt JC, Wang F, Trentacost DJ, et al. Outcomes of
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34. Packer M, Fine IH, Hoffman RS. Refractive lens exchange
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35. Kamath GG, Prasas S, Danson A, et al. Visual outcome with
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36. Sedgewick JH, Orillac R, Link C. Array multifocal intraoc-
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37. Kaushik S, Kamlesh S. A clinical evaluation of an aspheric
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38. Jacobi PC, Dietlein TS, Konen W. Multifocal intraocular
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40. Ripandelli G, Billi B, Fedeli R, et al. Retinal detachment after
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41. Fine IH: Corneal tunnel incision with a temporal approach.
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44. Fine IH. Cortical cleaving hydrodissection. J Cataract
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45. Hayashi K, Hayashi H, Nakao F, et al. Correlation between
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Refractive Lens Exchange 197
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51. Steinert RF, Aker BL, Trentacost DJ, Smith PJ, Tarantino N.
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Surg. 2002;28:421-424.

Use of Phakic Intraocular
Lenses in Pseudophakic Eyes
Patricia Sierra Wilkinson, MD and David R. Hardten, MD, FACS
Cataract surgery is the most commonly performed
refractive procedure in the world today.1 It has evolved to
the point where high levels of safety and efficacy are
expected. Due to the improved intraocular lens (IOL) cal-
culation formulas, modern cataract extraction, and IOL
implantation techniques, many of the difficulties and com-
plications faced by surgeons of previous eras no longer
occur. With improved techniques, the patient and sur-
geon’s expectations have also increased, and emmetropia
has become an integral goal of modern cataract surgery.
With the escalating popularity of corneal refractive sur-
gery and laser in-situ keratomileusis (LASIK) over the last
25 years, miscalculation of IOL power in patients who
have undergone previous refractive surgery has become a
concern among cataract surgeons. The frequency of
cataract surgery in these patients will continue to increase.
Experience with eyes after myopic refractive procedures
indicates that use of postoperative average standard ker-
atometric readings into standard IOL power predictive
formulas frequently results in substantial refractive errors,
hyperopia being the unexpected surprise in patients who
undergo myopic refractive procedures and myopia in
those undergoing hyperopic procedures.2-4
Anisometropia and residual refractive errors after
cataract surgery can be frustrating problems that conflict
with the patient’s high expectations and can cause signifi-
cant visual disturbances. These can occur as a result of
inaccurate biometry; manufacturing or calculation errors;
coexisting ocular pathology, such as staphyloma; or varia-
tions in the IOL position. Various techniques can be con-
sidered in order to approach these problems. Traditional
therapies for the management of pseudophakic ani-
20 Chapter
sometropia include glasses, contact lenses, addition of a
piggyback IOL, IOL exchange, or corneal refractive sur-
gery.5,6 Patients with unilateral pseudophakia have the
option of cataract surgery in the fellow eye, although this
technique may be undesirable if the lens is clear, accom-
modation is still present, or the first eye has an undesirable
refractive error.
Contact lenses offer a noninvasive approach; however,
some patients find them intolerable or are unable or
unwilling to use them. Corneal refractive surgery for the
correction of refractive errors and anisometropia includes
radial keratotomy (RK), photorefractive keratectomy
(PRK), LASIK, or conductive keratoplasty.7-10 Despite
excellent results obtained with some of these techniques,
there are still possible complications. Potential serious
complications after RK include loss of best-corrected visu-
al acuity, perforation of the cornea, infection, overcorrec-
tion, hyperopic shift, and potential rupture of the globe
with blunt trauma.11 PRK can induce corneal haze and
scarring, predominantly in patients with high refractive
errors. LASIK can be associated with flap and ablation
complications.12-14 Refractive corneal procedures also
have the disadvantage of irreversibly affecting the corneal
refractive power.
IOL exchange can be a challenging procedure, espe-
cially if performed after capsular contraction when the lens
is adherent to the capsular bag or the iris. If the posterior
capsule was torn during the original cataract surgery or if
a capsulotomy was subsequently performed, a capsular
tear, vitreous loss, retinal tears or detachment, and cystoid
macular edema can complicate the procedure itself.5,15-18
200 Chapter 20
Figure 20-1. STAAR Surgical ICL (reprinted with permission
from Zaldivar R, Oscherow S, Ricur G. The STAAR posterior
chamber phakic intraocular lens. Int Ophthalmol Clin. 2000;
40(3):237-244).
Implantation of supplementary lenses is another alterna-
tive for the treatment of high refractive errors as well as
pseudophakic ametropia. Gayton was the first to describe a
technique of implanting two IOLs in a microphthalmic eye
in 1993.19 Since then, the piggyback method of implanting
two IOLs in one eye has expanded to address pseudophakic
refractive error in normal eyes and eyes that have under-
gone postpenetrating keratoplasty. Piggyback implantation
has been combined with the use of minus-power lenses to
provide appropriate power for a cataract patient with kera-
toconus, as well as to correct pseudophakic myopia.20,21
Despite its success, the late complication of interlenticular
cellular growth with resultant hyperopic shift, opacification,
and loss of vision has recently become a concern.22,23
In search of a better alternative for the treatment of
pseudophakic ametropia, the use of phakic IOLs in
pseudophakic patients has been recently described. Chiou
et al24 reported the use of a posterior chamber phakic
Implantable Contact Lens (ICL) (STAAR Surgical AG,
Nidau, Switzerland) in patients who had developed
ametropia and anisometropia after unilateral phacoemulsi-
fication and in the bag IOL implantation. The STAAR
Surgical ICL was originally designed for the correction of
myopia and hyperopia in phakic patients (Figure 20-1).
The ICL is constructed of a hydrophilic collagen/hydrox-
yethyl methacrylate copolymer collamer with a refractive
index of 1.45 at body temperature. It is highly flexible and
only 60 µm thick, which is approximately 10 to 20 times
thinner than traditional IOLs (depending on the refractive
index and power). It has the same advantages of successful
IOL piggybacking, but is minimally invasive and may
avoid interface opacities.18,25
In their report, Chiou et al treated two patients who
had undergone traditional cataract phacoemulsification
and in the bag IOL placement who subsequently com-
plained of intolerable anisometropia.24 The manifest
Figure 20-2. Baïkoff or NuVita anterior chamber lens (reprinted
with permission from Baïkoff G. Intraocular phakic implants in
the anterior chamber. Int Ophthalmol Clin. 2000;40(3):223-
235).
refraction was - 6.00 - 0.50 x 50 in the first patient and
+4.50 -1.00 x 15 in the second. Postoperatively, after ICL
implantation in the ciliary sulcus, uncorrected visual acuity
had improved from 20/400 to 20/30 in the first patient and
from 20/200 to 20/40 in the second with manifest refrac-
tions of - 0.50 - 0.75 x 55 and + 1.50 - 1.50 x 30, respec-
tively, after 1 year. They reported no complications.
Hsuan et al obtained similar results after implantation
of the ICL in six eyes of pseudophakic patients to correct
anisometropia. The preoperative range of anisometropia
was 2.0 to 7.9 diopters (D). This was reduced to 0.0 to 3.5
D, with symptomatic resolution of the anisometropia in all
patients.18
Currently, there are several different types of phakic
IOLs for the treatment of myopia and hyperopia in clini-
cal use: anterior chamber angle-fixated IOLs, posterior
chamber sulcus-fixated IOLs, posterior chamber free-float-
ing IOLs, and iris-supported IOLs. Anterior chamber lens-
es such as the Baïkoff or NuVita lens (Figure 20-2) (Bausch
& Lomb Surgical, Rochester, NY),26 offer the advantage of
easy insertion using a technique with which most cataract
surgeons are familiar. Potential disadvantages include
pupillary ovalization from fibrosis around the footplate in
the anterior chamber angle or chronic compromise of the
anterior chamber angle, leading to glaucoma.26-28
Posterior chamber sulcus-fixated IOLs, such as the ICL
and the phakic refractive lens (PRL) (CIBA Vision, Duluth,
Ga),29,30 which are foldable, offering the advantage of
insertion through a small incision. They are placed far
from the anterior chamber angle and the corneal endothe-
lium. Potential disadvantages include angle closure from
forward displacement of the iris, pigment dispersion from
chafing, and cataract because of contact with the crys-
 Use of Phakic Intraocular Lenses in Pseudophakic Eyes
Figure 20-3. The Artisan phakic IOL (courtesy of Ophtec,
Groningen, Netherlands).
talline lens.31 The third category of phakic IOL includes
the anterior chamber iris-fixated lens or Worst-Fechner
claw lens. This lens attaches to the peripheral iris through
two pincer-like haptics. The only commercially available
lens in the United States is the Artisan phakic IOL
(Ophtec BV, Groningen, Netherlands) (Figure 20-3).32-34
To date, there have been no published reports of the
placement of other phakic IOLs in pseudophakic eyes.
Given the excellent outcomes of the Artisan lens in the
treatment of high myopia in phakic eyes,34 we could spec-
ulate that this would be a reasonable alternative in those
patients with pseudophakic ametropia. In theory, the risk of
endothelial cell loss might be decreased considering the
increased anterior chamber depth (ACD) in pseudophakic
eyes. Placement of an anterior chamber-supported phakic
IOL, such as the Baïkoff lens, might also be an alternative in
the treatment of pseudophakic ametropia. Even though
some reports of iris retraction and long-term endothelial
loss have been reported with the Artisan lens, this lens may
be promising as an alternative in the treatment of
pseudophakic ametropia, especially with the newer foldable
version that avoids the larger incision of the rigid style.35,36
As compared to other phakic IOLs, the ICL might offer
several advantages. Because it was originally designed for
use in phakic patients, it has a vaulted optic, which may
decrease axial touch and reduce the incidence of interface
opacities when used in piggyback implantation. In the
pseudophakic eye, there is obviously no risk of cataract
formation, which is the greatest risk in the phakic eye. Its
posterior chamber position minimizes endothelial cell loss
and trauma to the iris while preserving the advantage of the
smallest possible incision.18 The ICL also offers the advan-
tage of being reversible and not affecting the corneal
refractive power. Sanders et al37 reported the predictabili-
ty of the final refraction as well as the uncorrected and
best-corrected visual acuities to be better in a series of
myopic phakic patients given an ICL than in those treated
201
with PRK or LASIK. Despite its advantages, the ICL has
other known risks, including the development of pupillary
block (from inadequate iridectomies), increased intraocular
pressure, and case reports of neovascularization of the
angle and pigment deposition.38,39 Safe use of ICL requires
the formation of patent iridotomies as well as correct sizing
of the ICL based on the white-to-white distance.
Phakic IOLs may also have a role in the management of
other eye conditions. Eyes with poor capsular support
after phacoemulsification may benefit from the placement
of angle- or iris-supported IOLs offering a technically less
demanding and time-consuming surgery than sutured sul-
cus fixated IOLs. Gabor obtained good results in 15 eyes
of 12 patients with subluxated lenses in whom he implant-
ed an Artisan lens after phacoemulsification.40
In pseudophakic eyes with high astigmatism and unsatis-
factory correction with spectacles or contact lenses for med-
ical, professional, or personal requirements, the new toric
phakic IOLs may become a future alternative in addition to
the current surgical options of keratorefractive procedures
such as LASIK, PRK, or astigmatic keratotomy.41-43 In a
recent European 6-month clinical trial by Dick et al,44 the
implantation of the Artisan toric phakic IOL was demon-
strated to be safe, predictable, and effective in reducing or
eliminating high ametropia and astigmatism with one pro-
cedure in phakic patients.
SUMMARY
The use of phakic IOLs in pseudophakic patients may
be a safe and effective alternative in the management of
pseudophakic anisometropia. This technique may offer the
advantage of a minimally invasive and reversible proce-
dure. It may also be useful in introducing multifocal optics
into the pseudophakic eye for correction of presbyopia.
Only reports using the ICL are presently available. Similar
success may be obtained with the use of other phakic
intraocular lenses.
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 Use of Phakic Intraocular Lenses in Pseudophakic Eyes 203

40. Gobor R. Artisan IOL after phacoemulsification in subluxat-
ed lenses. J Cataract Refract Surg. 2002;28(11):2064.
41. Davis EA, Lindstrom RL. Astigmatism management: abla-
tion patterns. Curr Opin Ophthalmol. 2001;12(4):300-303.
42. Lindstrom RL, Agapitos PJ, Koch DD. Cataract surgery and
astigmatic keratotomy. Int Ophthalmol Clin. 1994;34(2):
145-164.
43. The surgical correction of astigmatism: a clinician’s perspec-
tive. Refract Corneal Surg. 1990;6(6):441-454.
44. Dick HB, Alio J, Bianchetti M, et al. Toric phakic intraocu-
lar lens: European multicenter study. Ophthalmology.
2003;110(1):150-162.
 21 Chapter

The Future of
Phakic Intraocular Lenses
David Rex Hamilton, MD, MS; David R. Hardten, MD, FACS;
Elizabeth A. Davis, MD, FACS; and Richard L. Lindstrom, MD

INTRODUCTION NEW APPLICATION:

Future developments in phakic intraocular lenses ANISOMETROPIC AMBLYOPIA
(IOLs) will focus on optimizing lens designs to decrease
Anisometropia is a significant risk factor for the devel-
long-term anterior segment complications; afford easier,
opment of amblyopia, particularly in high unilateral
less invasive surgical techniques; and expand clinical indi-
myopia. In addition, the condition is difficult to treat using
cations. We have already seen some of the design
the conventional technique of spectacle or contact lens
improvements in angle-fixated anterior chamber phakic
correction with occlusion, particularly when the ani-
IOLs to decrease endothelial cell loss and improve visual
sometropia is greater than 3.00 diopters (D).4,5 Refractive
function (see Chapter 17). Similar design improvements
surgery has been used recently to treat anisometropic
will likely be required to reduce incidence of cataract for-
amblyopia with encouraging results.6-9 The healing
mation from implant/natural lens touch with posterior
process of the pediatric cornea, however, is not well-
chamber phakic IOLs.1,2 A recent report by Sanders et al
understood, as evidenced by higher incidence of postop-
compares the incidence of anterior subcapsular opacities,
erative haze in these studies, even in cases in which laser
poor lens vault, and clinically significant cataracts between
in-situ keratomileusis (LASIK) was used. In addition, the
the now discontinued V3 design (87 eyes) and the newer
refractive status of the pediatric patient changes frequent-
V4 design (523 eyes) of the Implantable Contact Lens
ly. Techniques that remove corneal tissue may be subopti-
(ICL) (STAAR Surgical, Nidau, Switzerland). The V4
mal under such dynamic circumstances, ultimately limiting
design has an additional 0.13 to 0.21 mm of anterior vault,
future enhanceability. Lastly, very young pediatric
depending on the dioptric power of the lens (Figure 21-1).
patients may not be able to cooperate with the fixation
The study reports a statistically significant reduction in the
required during keratorefractive procedures.
incidence of late anterior subcapsular opacities (9.2% V3
The use of phakic IOLs may afford a more appropriate
vs 0.6% V4) and clinically significant cataracts (9.2% V3
solution for the treatment of anisometropic amblyopia.10
vs 0.8% V4).3
A recent study by Lesueur and Arne examined the use of
This chapter will examine foldable, toric anterior cham-
the ICL and postoperative patching to treat 12 eyes in
ber phakic IOLs, ultrathin lenses, light-adjustable IOLs,
patients ranging from age 3 to 16 with high myopic
and the exciting new frontier of accommodative IOLs. In
amblyopia (preoperative mean spherical equivalent: -12.70
addition to new lens designs, this chapter will discuss a
D, range: -8.00 to -18.00 D).11 With a mean follow-up of
new indication for IOLs: the treatment of severe ani-
20.5 months, all eyes except one gained lines of best cor-
sometropic amblyopia.
rected acuity with 70% of eyes gaining more than two
206 Chapter 21
Figure 21-1. Schematic demonstrating the difference in vaulting
characteristics between the V3 and V4 designs of the ICL. In this
-14.50 D ICL sectioned along its long axis, the V4 design demon-
strates 0.17 mm more vault compared to the V3 design (reprint-
ed with permission from Sanders DR, Vukich JA, ICL in
Treatment of Myopia Study Group. Incidence of lens opacities
and clinically significant cataracts with the ICL: comparison of
two designs. J Refract Surg. 2002;18:674).
lines of best corrected acuity. A trend toward lower
increase in axial length of operated eyes compared to
unoperated eyes was noted. Strabismus improved in all
patients following surgery, with four exotropic patients
recovering orthophoria postoperatively without strabis-
mus surgery and six patients recovering binocular vision.
There were significant gains in the quality of life reported
among all patients. No significant complications were
reported.
TORIC PHAKIC INTRAOCULAR LENSES
While the intraocular correction of astigmatism in the
phakic eye is currently in its infancy, there may be distinct
advantages of this method over keratorefractive tech-
niques. Current LASIK and surface ablation techniques
alter the corneal curvature from the ideal prolate shape to a
less optically ideal oblate shape. A toric phakic IOL, by
contrast, maintains natural corneal asphericity. In addition,
IOL implantation is reversible while ablative keratorefrac-
tive techniques are “enhanceable” but not truly reversible,
as corneal tissue is removed with each treatment.
The Toric Implantable Contact Lens
At the time of publication, there are several phakic
IOLs being investigated for the treatment of myopic astig-
matism. The first toric posterior chamber phakic IOL was
implanted by Thomas Neuhann, MD in Munich, Germany
in 1999 (unpublished data). The first implantation in
North America, a toric version of the STAAR ICL, was
recently reported by Gimbel and Ziemba.12 The 48-year-
old patient had a manifest refraction of -11.50 +2.25
x 008. Preoperative laser peripheral iridotomies were per-
formed at 11:00, 12:00, and 1:00 positions. The ICL
(-16.00 +3.50 x 002) was implanted through a 3.0-mm
Figure 21-2. Artisan phakic toric intraocular lens (courtesy
of Ophtec).
clear corneal temporal incision and rotated to align with a
mark at 180 degrees placed on the sclera preoperatively at
the slit lamp. Uncorrected visual acuity was 20/15-3 at 1
day and 20/15 at 5 months with a manifest refraction of
plano +0.25 x 150. There were no early or late complica-
tions seen. The STAAR toric ICL, based on the V4 design,
recently received marketing approval in Europe after
demonstrating rotational stability in eyes followed for
1 year.13 Clinical trials are ongoing in the United States.
The PRL does not have a toric version implanted to date,
as there is no rotational fixation of this posterior chamber
phakic IOL.
The Artisan Phakic
Toric Intraocular Lens
Artisan phakic toric IOLs, currently custom made by
Ophtec BV (Groningen, Netherlands), are designed for
the correction of regular astigmatism in combination with
myopia or hyperopia. Ophtec provides a recommendation
for the lens power and a special drawing indicating the
proper axes in which the lens should be implanted for each
individual case. The one-piece compression molded pha-
kic toric IOL is made of polymethylmethacrylate (PMMA)
and benzotriazole featuring a 5.0-mm, convex-concave
optic and overall length of 8.5 mm (Figure 21-2). The
anterior surface is spherical while the posterior surface is
spherocylindrical. The lenses are available from -3.0 to
-23.5 D for myopia and from +2 to +12 D for hyperopia
with cylindrical correction from 1.0 to 7.0 D.
Most surgeons implanting the spherical Artisan lens
prefer to position the IOL horizontally through a 12:00
incision. In keeping with this surgical technique, the
Artisan phakic toric IOL has been designed in two models
to allow the lens to be positioned in an oblique horizontal
position, regardless of the axis of astigmatism (Figure 21-

Figure 21-3A. Two models of Artisan phakic toric IOL.
Model A has the torus axis oriented along the long axis of
the lens and is designed for eyes with refractive astigmatic
axis from 0 to 45 degrees or 135 to 180 degrees. In this
example, the lens is enclavated 15 degrees counterclock-
wise from the horizontal to treat -15.0 -5.0 x 015 (courtesy
of Ophtec).
3). Model A is a negative cylinder lens that has the torus
axis running through the horizontal axis (ie, at 0 degrees).
It is intended for implantation in eyes with astigmatic axes
between 0 and 45 degrees or between 135 and 180
degrees. Model B is a negative cylinder lens that has the
torus axis running through the vertical axis (ie, 90 degrees
from the long axis of the lens). It is intended for implanta-
tion in eyes with astigmatic axes between 45 and 135
degrees. Positive and negative cylinder lenses are avail-
able. The axis of enclavation has to be exact.
Consequently, marking the axis on the iris with argon laser
or on the sclera at the slit lamp preoperatively is essential.
The results of a large prospective, multicentral trial from
15 centers examining the efficacy and safety of the Artisan
phakic toric IOL in 70 eyes of 53 patients with 6-month
follow-up was recently reported.14 The study looked at
both myopic astigmatism (group A: N = 48, mean preoper-
ative spherical equivalent [SE] = -8.90 D) and hyperopic
astigmatism (group B: N = 22, mean preop SE = +3.25 D)
with an overall range of SE from +6.50 to -21.25 D and
cylinder ranging from 1.50 to 7.50 D. Safety results were
excellent at 6 months with no eye losing a line of best cor-
rected acuity. Sixty-nine percent and 59% of myopic and
hyperopic eyes, respectively, gained at least one line of
best corrected acuity. Eighty-five percent and 96% of
myopic and hyperopic eyes, respectively, had uncorrected
acuity of 20/40 or better 6 months postoperatively. All eyes
in both groups were within ⫾ 1.0 D of the desired refrac-
tion at 6 months. There was a 4.5% mean endothelial cell
loss during the 6-month follow-up, the majority of which
The Future of Phakic Intraocular Lenses 207
Figure 21-3B. Two models of Artisan phakic toric IOL.
Model B has the torus axis oriented along the vertical axis
of the lens and is designed for eyes with refractive astig-
matic axis between 45 and 135 degrees. In this example,
the lens is enclavated 10 degrees clockwise from the hor-
izontal to treat +4.0 -6.0 x 080 (courtesy of Ophtec).
appeared at the 1 week visit. Subjective patient satisfaction
was very high, with a mean rating of 9.0 out of 10.0 at
6 months. Overall, this lens may offer an excellent option
to selected patients with high myopia or hyperopia with
astigmatism vs bioptics, which carries with it risks associat-
ed with the flap, including epithelial ingrowth (see Chapter
18).15 Careful patient selection, including accurate meas-
urement of anterior chamber depth (Dick et al14 recom-
mend anterior chamber depth >3.0 mm) and pupil size
(scotopic pupil ideally less than optic size), precise refrac-
tion, preoperative determination, and marking of the cylin-
der axis are essential for a successful result. Decentration of
the lens in hyperopic eyes may be necessary, as the visual
axis may not lie in the middle of the pupil.
This lens may also provide an efficacious option for the
correction of phakic, postpenetrating keratoplasty
ametropia with astigmatism. A recent case series of 12 eyes
reports a two or more line improvement of best-corrected
visual acuity in 50% of eyes.16
FOLDABLE PHAKIC
INTRAOCULAR LENSES
The major posterior chamber phakic IOLs (ie, ICL and
PRL [Medennium, Irvine, Calif]) are already foldable and,
as a result, may be inserted through small, clear corneal
incisions (see Chapters 12 and 14). Bausch & Lomb
Surgical (Rochester, NY) is testing a foldable version of
the NuVita anterior chamber, angle-fixated phakic IOL.
208 Chapter 21
Figure 21-4. Artiflex flexible phakic IOL. The silicone optic flex-
es along its long axis and may be inserted through a 3.6-mm
incision using the specially designed lens insertion system
shown (courtesy of Ophtec).
Figure 21-6. ThinOptx Ultrachoice 1.0 lens
optic design. The lens power is determined
by the difference in curvature of the anteri-
or and posterior surfaces. While one sur-
face retains a continuous curvature, the
second surface is lathe cut to maintain
optical power while minimizing thickness.
Each step or ring on the second surface has
a different curvature so as to minimize
spherical aberration and maintain a single
focal point (courtesy of ThinOptx, Inc).
This foldable lens features an optic made of hydrogel that
will go through a 3-mm incision, approximately half the
size of the incision required for the current NuVita MA20
that is popular in Europe, Asia, and South America (see
Chapter 15).
The Foldable Artisan
Phakic Intraocular Lens (Artiflex)
A foldable version of the major iris-fixated anterior
chamber phakic IOL (the Artisan, which is to be marketed
as the Verisyse in the United States [Advanced Medical
Optics, Irvine, Calif]) has recently been introduced and is
undergoing clinical trials in Europe. The rigid optic of the
original design has been replaced by a flexible silicone
optic, while the PMMA haptic design remains. The lens
“flexes” along its long axis and may be inserted through a
3.6-mm incision using a specially designed insertion sys-
Figure 21-5. ThinOptx
Ultrachoice 1.0 IOL. A.
Packaged, rolled up
form. B. Unrolled, plate
form (courtesy of Thin-
Optx, Inc).
A.
B.
tem (Figure 21-4). Once inside the anterior chamber, the
claw fixation mechanism is spread open with a double arm
grasping technique or with a single arm fixation forceps.17
Early trials have shown promising results.18
ULTRATHIN INTRAOCULAR LENSES
The size of clear corneal incisions has continually
decreased since the introduction of phacoemulsification.
Recent advances in surgical technology, including laser
and low energy, pulsed phaco techniques coupled with
bimanual instruments, have allowed incision sizes to
decrease below 1.5 mm. The inability to insert a lens
through such a small incision, however, has limited the use
of these new techniques. Several new ultrathin lenses that
may provide additional options for the phakic IOL patient
are now on the horizon.
ThinOptx Ultrathin Intraocular Lenses
The Ultrachoice 1.0 lens (ThinOptx, Abingdon, Va),
manufactured using nano-scale precision technology, is an
ultrathin, rollable IOL with dioptric powers ranging from
-25 D to +30 D in 0.125 D increments and lens thickness
ranging from 30 to 350 ␮m, depending on dioptric power
(Figure 21-5). The posterior surface of the optic is one
continuous curve, while the anterior surface is lathe cut
with a series of steps, 50 ␮m in height, in a concentric pat-
tern (Figure 21-6). This design allows the lens to remain
extremely thin, even with large dioptric powers. Unlike a
Fresnel lens, in which each concentric section has a differ-
ent focal point, each concentric section in the Ultrachoice
1.0 has a different radius of curvature to create one focal
point for the entire lens, thus reducing spherical aberration
(Figure 21-7). The lens may be inserted through a 1.5-mm
incision in a rolled configuration (Figure 21-8). The lens
then unrolls into a posteriorly vaulted plate configuration
 The Future of Phakic Intraocular Lenses 209

Figure 21-8. Implant-

ation of the Ultrachoice
1.0 Thin lens. A. The
lens is inserted in rolled
up form through a sub-
2.0-mm clear corneal
incision. B. The lens is
inserted into the capsu-
Figure 21-7. Ultrachoice 1.0 thin lens is lar bag (courtesy of
not a Fresnel lens. A Fresnel lens (left) has A. ThinOptx, Inc).
multiple focal points. The Ultrachoice lens
is designed such that all light rays focus at
a single point (courtesy of ThinOptx, Inc).

Figure 21-9. Ultrachoice

1.0 thin lens in-vivo
configuration. A. The
lens unfolds in the cap-
sular bag into a plate
configuration. B. Eyelets
in the plate haptic
should point in a clock-
wise direction, ensuring
B.
A. proper front/back orien-
tation. In-vivo, the lens
rests in a posterior vault- Figure 21-10. ThinOptx
ed orientation as shown angle-supported anterior
(courtesy of ThinOptx, chamber phakic IOL
Inc). (courtesy of ThinOptx,
Inc).

The Vision Membrane

B. This 200-␮m thick, angle-fixated, anterior chamber
lens (Vision Membrane Technologies, Carlsbad, Calif)
makes use of diffractive optics to correct myopia from -
2.00 to -15.00 D and hyperopia from +2.00 to +6.00 D.
and fixates in the capsular bag (Figure 21-9). ThinOptx
The foldable lens may be implanted through a sub-2.0 mm
has also developed an anterior chamber, angle-fixated
incision. In addition to its extremely thin design, which
phakic version of the Ultrachoice 1.0 featuring the same
may offer advantages with regard to endothelial cell loss,
type of ultrathin optic (Figure 21-10). A high-resolution
intraocular inflammation, and cataract formation, the lens
ultrasound shows the position of the phakic IOL relative
features a large 6.5-mm optic. Particularly with myopic
to the corneal endothelium and natural lens (Figure 21-
patients, this large optic size may be more forgiving rela-
11). Eight implants have been placed with good efficacy
tive to decentration and subsequent aberrations with large
and safety to date.19
210 Chapter 21
Figure 21-11. High resolution ultrasound image of an implanted
ThinOptx phakic IOL. Note large corneal/lens distance due to
thin lens thickness (courtesy of ThinOptx, Inc).
pupils than other anterior chamber lenses with smaller
optics. The company plans to offer a bifocal version to
address the presbyopic market. Several lenses have been
implanted outside the United States with good success.
European and US trials may begin during the third and
fourth quarter 2003.20
LIGHT ADJUSTABLE
INTRAOCULAR LENSES
Ametropia following phakic IOL implantation will
inevitably occur as these lenses become integrated into the
surgical armamentarium of refractive surgeons. The Van
der Heijde formula, used to calculate dioptric power of
phakic IOL, does not use the axial length, removing one
possible source of measurement error present in standard
IOL calculations.21 However, it does make use of an esti-
mation of the distance between the corneal plane and the
IOL plane, the anterior chamber depth, as well as the
patient’s subjective refraction. While lens exchange or
bioptics are certainly options for the patient with signifi-
cant ametropia following phakic IOL implantation, a
much less invasive approach may be available in the future.
A Light Adjustable Lens (LAL) (Calhoun Vision, Inc,
Pasadena, Calif) is currently under development.22,23 This
technology is designed to provide noninvasive adjustment
and correction of residual postimplantation refractive
errors following cataract surgery by applying near-ultravi-
olet light to an IOL composed of a cross-linked silicone
polymer matrix, a guest macromer, and a photoinitiator.
The application of the appropriate wavelength of light
onto the central optical portion of the LAL polymerizes
the macromer in the exposed region, thereby producing a
difference in the chemical potential between the irradiat-
ed and nonirradiated regions. To re-establish thermody-
namic equilibrium, unreacted macromer and photoinitia-
tor diffuse into the irradiated region. As a consequence of
the diffusion process and the material properties of the
Figure 21-12. LAL: mechanism of action. Schematic illustrating
the proposed mechanism of swelling. A. Selective irradiation of
the central zone of the IOL polymerizes macromer, creating a
chemical potential between the irradiated and nonirradiated
regions. B. To re-establish equilibrium, excess macromer diffus-
es into the irradiated region, causing swelling. C. Irradiation of
the entire IOL “locks” the macromer and the shape change
(courtesy of Calhoun Vision, Inc).
host silicone matrix, the LAL will swell, producing a con-
comitant decrease in the radius of curvature of the lens and
a corresponding increase in lens power (Figure 21-12).
This process may be repeated if the surgeon wants further
refractive change in the lens. The surgeon may then irra-
diate the entire lens, consuming the remaining, unreacted
macromer and photoinitiator. This action effectively locks
in the refractive power of the lens. The surgeon may
induce a myopic change by irradiating the edges of the
LAL to effectively drive macromer and photoinitiator out
of the lens’ central region, thereby increasing the radius of
curvature and decreasing the power. Animal studies in rab-
bits have found no significant inflammation or signs of
toxicity, including no corneal changes, following maxi-
mum light exposure.24 Initial human trials are set to begin
this year. The company plans to develop the technology
for phakic IOLs in the future.
ACCOMMODATIVE MULTIFOCAL
INTRAOCULAR LENSES
The primary stimulus for the development of phakic
IOLs was to avoid the loss of natural accommodation
resulting from clear lens extraction in young, prepresby-
opic eyes. Another concern, particularly in highly myopic
eyes, is the risk of retinal detachment, either as a result of
surgical manipulation during lenticular surgery and/or
from the anatomically altered pseudophakic lens/cap-
sule/zonule/ciliary body apparatus. Multifocal IOLs have
been used in cataract surgery for a number of years, pro-
viding adequate pseudoaccommodative results for some
elderly patients who have long since lost natural accom-
modation and who are tolerant of compromised near and
distance visual function.

Figure 21-13. Array
multifocal silicone lens
(courtesy of Advanced
Medical Optics).
Array Multifocal Intraocular Lens
The Array lens (Advanced Medical Optics, Irvine,
Calif) received US Food and Drug Administration (FDA)
approval in September 1997 and is the most commonly
implanted multifocal lens in the United States (Figure 21-
13). This silicone lens has a 6.0-mm optic that is a “zonal
progressive” design in that it incorporates five blended
aspheric zones of power on the anterior surface. The cen-
tral 2.1 mm is dedicated to distance vision while the ring
from 2.1 to 3.4 mm is for near vision. There are three more
peripheral zones for distance and near. The Array lens is
“distance dominant” because 50% of the light transmission
is assigned to distance, 13% to intermediate, and 37% to
near vision. A large, multi-center, prospective study by
Steinert et al examining the Array lens in 400 subjects with
1-year follow-up found 77% of eyes had both 20/40 or
better uncorrected distance vision and J3 or better near
vision, compared with only 46% of eyes implanted with a
conventional, monofocal lens.25 The study also found that
a significantly higher percentage of subjects implanted
bilaterally with the Array lens reported they could func-
tion comfortably without glasses at near compared with
those subjects implanted with one Array and one multifo-
cal lens (81% vs 56%, p <0.001). Subjects receiving the
multifocal lens lost about one Snellen line of low-contrast
visual acuity compared to those receiving the monofocal
implant and also reported more glare and halos. Smaller
studies have reported similar findings,26-28 including some
decrease in simulated driving performance.29 Effective
patient selection is paramount when deciding who will
benefit from multifocal lens implantation. Patient charac-
teristics that may suggest good candidacy for multifocal
lens implantation include high motivation for spectacle
independence, willingness and ability to have bilateral
implantation, minimal or easily treatable corneal astigma-
tism, hyperopia, Alzheimer’s patients (often lose specta-
The Future of Phakic Intraocular Lenses 211
cles), certain occupations (mechanics, musicians, librari-
ans), and certain sports enthusiasts (tennis, golf, shooting
sports).30 Many of these patients will be quite happy with
the results of multifocal lens implantation.
The ThinOptx ultrathin lens was recently found to
produce good near vision, even through distance correc-
tion.31 Since this lens is not a true multifocal design, any
“accommodation” must result from anterior movement of
the lens. Ultrasound studies of the ThinOptx lens in vivo
have shown some anterior movement up to the third post-
operative month. The mechanism whereby the lens (natu-
ral or implant) moves forward to provide near vision has
been extensively investigated and utilized in the develop-
ment of true accommodative IOLs.
True Accommodative
Intraocular Lenses
The functional results of pseudoaccommodation from
multifocal lenses do not compare to that afforded by the
natural lens. As a result, multifocal lenses do not offer a
viable option for young prepresbyopic patients. A truly
accommodative IOL would be a unifocal design that,
through mechanical deformation or movement, alters that
unifocality to a near focal point in response to an accom-
modative stimulus. The development of an effective, sta-
ble, safe, and truly accommodative IOL would not only
revolutionize cataract surgery but would also likely sup-
plant the position of phakic IOLs in the armamentarium of
refractive surgeons.
History
In 1955, Busacca observed that the ciliary muscle mass
encroached on the vitreous cavity during chemically
induced ciliary muscle constriction in an aniridic patient.32
He also observed that the zonular insertions on the lens
moved anteriorly during ciliary muscle constriction. In
1986, Coleman directly measured a simultaneous increase
in vitreous cavity pressure and decrease in anterior cham-
ber pressure following stimulation of the ciliary muscle in
10 primate eyes.33 Subsequently, Cumming noticed that
some pseudophakic patients with plate haptic lenses were
able to read J2 and J3 through best distance correction,
having removed factors that might improve near vision,
such as uncorrected myopia and with-the-rule astigma-
tism. Using A-scan ultrasonography, Cumming observed a
forward shift in posterior chamber IOL position by an
average of 0.7 mm in 10 patients between installation of
pilocarpine and a cycloplegic.34 With previous historical
information and his own experience, Cumming set out to
design a hinged-plate haptic IOL that would move for-
ward with accommodative effort due to increased vitreous
pressure on the optic (Figure 21-14). The first design con-
sisted of a hinged-plate haptic with a 4.5-mm optic, the
212 Chapter 21
Figure 21-14. Increased vitreous pressure from ciliary muscle
contraction may push lens forward, increasing lens power dur-
ing accommodation (courtesy of C & C Vision).
optic diameter reduced to provide a longer lever arm of
the hinged haptic mechanism, affording a larger anterior
movement of the optic. The first lens was implanted in an
85-year-old patient in 1991. Four months postoperatively,
the lens movement was analyzed by A-scan ultrasonogra-
phy. After instillation of pilocarpine, the anterior chamber
depth (cornea to anterior surface of lens) was noted to
decrease by 2.5 mm while the vitreous cavity length was
noted to increase by 2.5 mm, confirming good efficacy of
the hinged-plate haptic design. Unfortunately, the lens
had a tendency to dislocate into the ciliary sulcus.
CrystaLens: Silicone
Accommodative Intraocular Lens
Over the next 7 years, Cumming and Kammann revised
the design of the lens multiple times to reduce the incidence
of anterior dislocation into the ciliary sulcus. The final
design, known as the AT-45, to be marketed as CrystaLens
(C&C Vision, Aliso Viejo, Calif), is shown in Figure 21-15.
The lens is a modified three-piece plate haptic design made
from a third generation, high refractive index silicone mate-
rial containing an ultraviolet filter. The lens features hinges
located adjacent to the biconvex 4.5-mm optic, running
across the plates, to decrease resistance to forward motion.
Fixation within the bag is ensured by small, T-shaped
polyamide haptics at the end of the plates. The overall
length of the lens is 10.5 mm. The lens may be folded and
inserted through a 3.0-mm incision.35-37 Atropine is given
at the end of the case and the following day to stabilize the
lens during the initial period of fibrosis.
Results of clinical trials of the CrystaLens have demon-
strated excellent safety and improved efficacy over multi-
Figure 21-15. CrystaLens silicone accommodative IOL featuring
a 4.5-mm optic and hinged haptics, each with two polyamide
feet (courtesy of C & C Vision).
focal and conventional IOLs with regard to uncorrected
distance, intermediate, and near vision.38 One-year results
from the FDA Phase I trial on 369 eyes and 124 bilateral-
ly implanted patients were recently presented.39 Figure 21-
16 highlights the efficacy data. Bilateral results were some-
what better than unilateral results, underscoring an impor-
tant factor for patient counseling when considering an
accommodative implant. One hundred percent of bilater-
ally implanted patients saw 20/40 or better at near and
intermediate through distance correction. These results
represent a new level of efficacy in pseudophakic near
vision when compared to previous conventional monofo-
cal implants (Table 21-1).25,40 The study also reports dis-
tance-corrected near acuity results on 56 eyes after
neodymium:yttrium-aluminum-garnet (Nd:YAG) capsulo-
tomy. Significant improvements were seen at 20/25, 0/32,
and 20/40. Pre-Nd:YAG percentages were 17.6%, 29.4%,
and 76.5%, respectively. Post-Nd:YAG percentages were
29.4%, 61.8%, and 94.1%, respectively. Zaldivar reports a
larger improvement in uncorrected near acuity following
large versus small capsulotomy.37 Four-year data on six
bilaterally implanted patients has been reported.41. One
hundred percent have near visual acuity of 20/40 or better
through distance correction. The small optic size of 4.5
mm may not cause scotopic vision problems due to the
posterior position the lens assumes in the unaccommodat-
ed state. Because of its hinges, the CrystaLens sits very
posterior in the capsule. As a result, the lens is closer to the
nodal point of the eye where all the light rays converge to
a single point, limiting the diameter through which light
enters the lens. Contrast sensitivity also appears to be
excellent. A study by Colvard found no difference in con-
trast sensitivity between the CrystaLens and a convention-
al intraocular lens.42
 The Future of Phakic Intraocular Lenses 213

Figure 21-16A. One-year postoperative results of CrystaLens US Figure 21-16B. One-year postoperative results of CrystaLens US
FDA Trial. Uncorrected distance visual acuity (reprinted with FDA Trial. Uncorrected near visual acuity (reprinted with per-
permission of C & C Vision). mission of C & C Vision).

Figure 21-16C. One-year postoperative results of CrystaLens US Figure 21-16D. One-year postoperative results of CrystaLens US
FDA Trial. Distance-corrected near visual acuity (reprinted with FDA Trial. Distance corrected intermediate visual acuity (reprint-
permission of C & C Vision). ed with permission of C & C Vision).

Table 21-1

COMPARISON OF NEAR VISUAL ACUITY RESULTS BETWEEN

CRYSTALENS AND PREVIOUS MONOFOCAL INTRAOCULAR LENSES
Accommodative IOL Conventional Monofocal IOL
CrystaLens US FDA Trial Steinert et al25 Lindstrom40
Number of eyes 369 102 205
UCNVA 20/40 or better 89% 49% 38%
DCNVA 20/40 or better 91% 48% 37%

UNCVA = uncorrected near visual acuity

DCNVA = distance-corrected near visual acuity

1CU: Acrylic AG, Erlangen, Germany) posterior chamber accommoda-

Accommodative Intraocular Lens
Based on finite element computer models that simulate
changes of the ciliary body-zonule-lens apparatus, KD
Hanna and colleagues developed the 1CU (HumanOptics
tive IOL (Figure 21-17). This hydrophobic acrylic lens
features a 5.5-mm optic attached to four hinged haptics
that allow anterior movement of the optic during accom-
modation (Figure 21-18). A standard 3.2-mm clear-corneal
incision may be used to inject the lens into the capsular
214 Chapter 21
Figure 21-17A. 1CU acrylic accommodative IOL
(courtesy of HumanOptics AG).
Figure 21-18A. 1CU lens in unaccommodated
state, haptics unflexed, zonules tight (courtesy of
HumanOptics AG).
bag. The capsulorrhexis must be 5.5 mm or less to com-
pletely overlap the edge of the optic so the hinged mech-
anism can work properly (Figure 21-19). The lens haptics
should be placed at the 12:00, 3:00, 6:00, and 9:00 posi-
tions and care should be taken to fully remove all vis-
coelastic material from behind the lens optic.
Postoperative medications are similar to standard cataract
surgery with the addition of a short acting mydriatic that
is continued twice daily for 4 weeks. As a result, near
vision does not begin to improve until after discontinua-
tion of the mydriatic.
As of October 2002, the lens had been implanted in over
120 eyes as part of a large 16 center study in Germany, Italy,
and Japan. A recent study by Kuchle et al reported efficacy
and safety results on 20 eyes implanted with the 1CU com-
pared to 20 age-matched controls implanted with a conven-
tional intraocular lens.43,44 Monocular mean near acuity
(measured at 35 cm) through best distance correction was
Figure 21-17B. 1CU lens features a 5.5-mm optic with four
hinged haptics (courtesy of HumanOptics AG).
Figure 21-18B. 1CU in accommodated state,
haptics flexed, zonules loose, optic anteriorly
displaced (courtesy of HumanOptics AG).
20/60 in the 1CU eyes compared to 20/150 in the conven-
tional implant eyes (p = 0.001). Simoma reported a direct
comparison between the 1CU (18 eyes) and the CrystaLens
(14 eyes).45 The mean near acuity through best distance cor-
rection was 20/60 for both groups. Reports of post-Nd:YAG
capsulotomy distance-corrected near acuity are not available.
Long-term follow-up on a large cohort of patients will be
required to assess how the efficacy and longevity of restored
accommodation with this lens compares to that established
by the CrystaLens US FDA trial data.
SmartLens Accommodative
Intraocular Lens
The young, natural lens has a remarkable ability to
accommodate. If the properties of the young lens could be
duplicated in a synthetic device that could be introduced
into the capsular bag in such as way as to restore the natu-
ral ciliary muscle-zonule-lens capsule relationship, accom-
modation would likely be restored. For many years,
researchers have investigated this concept through the

Figure 21-19. Transillumination image of 1CU lens in the
capsular bag 1 year after surgery. Note small size of capsu-
lorrhexis necessary to overlap 5.5-mm optic (courtesy of
HumanOptics AG).
Figure 21-20B. SmartLens in-vivo dimensions. Thickness
varies from 2.0 to 4.0 mm depending on dioptric power;
average thickness = 3.5 mm (courtesy of Medennium, Inc).
development of liquid or flexible polymer materials that
could be injected into the empty capsular bag.46-49
Multiple difficulties have been encountered: containing the
liquid within the capsule without leakage; using balloons50;
implanting a full size, flexible polymer lens through a small
incision if it is not liquid, preventing capsular opacification
from occurring;51 and controlling the shape and, ultimate-
ly the accommodative amplitude of the liquid or flexible
polymer-filled bag.52 Ultimately, the advances in cataract
surgical instrumentation and small incision, capsulorrhexis
techniques have reduced the problem to one of material
science and biocompatibility. Early attempts examined the
safety of in-vivo polymerization of a liquid monomer con-
trolled by light exposure.53,54 Silicone polymeric gels were
also used with some success in primates, only to be foiled
by lens epithelial cell proliferation and subsequent posteri-
or capsular opacification.55,56 While none of these proto-
types were ever developed into a commercial product, both
Nishi and Haefliger independently showed that accommo-
dation could be restored in primate eyes by removing the
native, presbyopic lens and refilling the capsular bag with a
soft gel lens.47,56
The Future of Phakic Intraocular Lenses 215
Figure 21-20A. SmartLens in-vivo dimensions. Diameter =
9.5 mm (courtesy of Medennium, Inc).
A recently developed lens technology may have the
answer to many of these previously unconquered chal-
lenges. The SmartLens (Medennium, Inc, Irvine, Calif) is
made of a thermodynamic, hydrophobic acrylic material.
At body temperature, the biconvex lens is 9.5 mm in diam-
eter and from 2 to 4 mm thick, depending on the specific
dioptric power requirements to which it was manufactured
(Figure 21-20). The lens is highly flexible and completely
elastic, returning to its original shape when deforming
forces are released (Figure 21-21). The lens is packaged as
a 30-mm long, 2-mm wide cylinder at room temperature
(Figure 21-22). Once injected into the capsular bag
through a sub-3-mm incision, the thermodynamic,
hydrophobic material is transformed by exposure to body
temperature and assumes the precise shape for the dioptric
power “imprinted” earlier during the manufacturing
process (Figure 21-23). The transformation process from
the rod into the biconvex, flexible lens that completely
fills the capsular bag takes about 30 seconds (Figure 21-
24). After this transformation process, the lens is dimen-
sionally and optically stable.
Several other useful properties have been engineered
into this novel material. The hydrophobic acrylic has a
high tackiness that will adhere closely to the capsule, min-
imizing lens epithelial cell migration and virtually elimi-
nating mechanical stability and decentration concerns.
The material also has a high index of refraction that should
provide significant accommodative effect from only small
changes in lens shape or position. The lens is in its early
stages of development, currently undergoing toxicity and
optical bench studies with initial clinical implantation pro-
jected for 2005.
Many issues remain to be resolved regarding true
accommodative IOLs, particularly with regard to use in
prepresbyopic eyes. First and foremost, a reproducible
amplitude of accommodation of at least 3.0 D will be
required before such a lens would be considered an appro-
priate replacement for the natural lens in a prepresbyopic
216 Chapter 21
A.
Figure 21-21. SmartLens flexibility. The highly flexible polymer (A) has perfect elasticity, returning completely to its uncompressed
shape when compressive force is removed (B) (courtesy of Medennium, Inc).
Figure 21-22. SmartLens cylinder configuration. The lens is
packaged as a 30-mm long, 2-mm wide cylinder at room
temperature (courtesy of Medennium, Inc).
patient. Secondly, it stands to reason that the accommo-
dation afforded by these lenses will depend on the power
of the lens implanted: for the same shift in lens position, a
lens of high power would afford a larger amplitude of
accommodation when compared with a lens of lower
power. This issue, relevant mainly to lens designs requir-
ing an axial shift of a nondeformable optic to provide a
power change (eg, CrystaLens and 1CU designs), may be
a significant issue in high myopes who typically require a
very low power lens implant to achieve emmetropia.
Finally, a surgeon must feel comfortable that the risk of
retinal detachment is sufficiently low to justify invading
the natural lens/capsule/zonule/ciliary body apparatus.
Until such time that these issues are sufficiently resolved,
phakic IOLs will play a significant role in the treatment of
highly ametropic eyes.
Many of the complex issues involved with phakic IOL
design have been resolved with the latest generation lens-
es. As FDA trials near completion for several lens designs,
upcoming years will provide an exponential increase in
clinical experience with phakic IOLs, undoubtedly uncov-
ering unforeseen benefits and difficulties. The develop-
B.
Figure 21-23. SmartLens implantation. Once injected into the
capsular bag through a sub-3-mm incision, the thermodynamic,
hydrophobic material is transformed by exposure to body tem-
perature and assumes the precise shape for the dioptric power
“imprinted” earlier during the manufacturing process (courtesy
of Medennium, Inc).
ment of safe, effective keratorefractive techniques over the
last decade and the promising advancements afforded by
wavefront technology in recent years are truly remarkable
for ophthalmology. It may be the addition of phakic IOLs,
however, that will augment the armamentarium of the
refractive surgeon to a point where no refractive challenge
will be left unconquered.
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 Index

ablation complications, 185-187 anesthesia and surgical techniques, 155-157

accommodative IOLs, 194-194, 210-216 clinical outcomes in myopic patients, 157-159
ametropia, 107 design, 152-153
angle crowding, 108 historical perspectives, 16, 17, 151
angle-supported phakic IOLs indications, 151-152
anterior chamber lens power, 164 measurements, 153-155
clinical outcomes, 164-167 in pseudophakic eyes, 200
complications, 81-84 Barraquer, Joaquin, 13, 167
historical perspectives, 163, 167-168 Barraquer lens, 15
patient selection, 163-164 Bausch & Lomb Surgical/Chiron Vision Model NuVita
postoperative care, 164 MA20 lens, 16
surgical techniques, 164 best-corrected visual acuity (BCVA), 24, 70, 73, 102, 117,
anisometropia, 199-200, 205-206 166-167. See also UCVA
anterior chamber angle-supported phakic IOLs, 81-84 biconvex disc, 13
anterior chamber depth (ACD), 81-82, 85, 93-94, 122, 201 biometry, 40
anterior chamber iris-fixated lenses, 18 bioptics
Anterior Chamber Optical Coherence Tomograph astigmatism management, 63-64, 68-69
Scanner, 155 case study, 179
aphakia, 15 complications, 182-187
Array multifocal IOL, 211 considerations, 177
Artesian lens, 17 corneal incisions, 73
Artisan phakic IOL indications, 177-179
anesthesia techniques, 47-48 LASIK follow-up, 182
Artiflex, 208 lens power calculations, 42-43
clinical outcomes, 137-140 preoperative evaluation, 179-180
complications, 142-143 surgical techniques, 157, 180-182
contraindications, 134-135 BSCVA (best spectacle-corrected visual acuity, 134, 166.
design, 108-109 See also UCVA
development, 133-134 BSS (balanced salt solution), 99
historical perspectives, 133 button hole, 185
for hyperopia, 140
for myopia, 141-142 cataract formation, 81, 84, 89, 90-91, 159
patient selection, 134 cataract surgery, 189, 199. See also refractive lens ex-
preoperative evaluation, 134-135 change
surgical techniques, 100-102, 135-137 central corneal refractive power, 40
toric model, 109, 113, 140-141, 206-207 central island, 185-186
visual acuity, 4 Choyce, Peter, 13, 167
A-scan units, 40, 211 chronic inflammation, 82, 86
astigmatism management, 5, 58, 59-64 clear lens extraction. See refractive lens exchange
axial length, 40 cocaine, 48-49
Cogan Boberg-Ans fenestrated lens, 14
Baïkoff, G., 167 Coleman, Jackson, 193-194
Baïkoff’s foldable anterior chamber phakic IOL conductive keratoplasty (CK), 2, 6-7, 21, 64, 199
222 Index

contrast sensitivity, 3, 26, 38, 190-191, 194 Phase III trial for the hyperopic iris-claw phakic IOL,
corneal asphericity, 3, 5 85, 109, 137, 142, 146-147
corneal edema, 159, 187 free cap, 185
corneal endothelium, 29-30, 159 Fyodorov, Svyatoslov, 17-18, 167
corneal guttata, 30
corneal neovascularization, 21 gas permeable contact lenses, 30
corneal refractive surgery. See also hyperopia; myopia GBR lens, 110, 152-153, 157
clinical outcomes, 72-74 general anesthesia, 52-53
complications, 73-76 glare
contraindications, 69-70 with AC phakic IOLs, 83, 89, 94
enhancement procedures, 72 with Artisan phakic IOL, 117
future developments, 37, 76-77 edge glare, 39
indications, 69 following LASIK, 3, 24
myopic, 6 pupil size and, 26
postoperative course, 72 glaucoma, 83-84, 89, 91-93, 159
range of correction, 67-69 globe perforation, 50
surgical techniques, 72 gonioscopy, 152
corneal steepening, 5 Greenbaum cannula, 51
corneal thickness, 4
corneal topography, 58 halos
crystalline lens, 37, 212-213 with AC phakic IOLs, 83, 89, 94
Cumming, Stuart, 194 with Artisan phakic IOL, 117
following LASIK, 3, 24
Dannheim lens, 15 night vision, 159
decentered ablations, 185 pupil size and, 26
decentration, 93, 117 haptics, repositioning, 156
diffuse intralamellar keratitis (DIK), 186-187 Hartmann-Shack principles, 180
dry eye, 75, 152 haze, 4-5, 21
Hoffer Q formula, 193
effective lens position (ELP), 40, 42 Hollis, Stephen, 58
edge glare, 39 horizontal corneal diameter, 40
emmetropia, 7, 136 “Hurriet Law”, 157
endophthalmitis, 71 hyaluronidase, 49-50
endothelial cell counts, 29-32, 134 hyperopia. See also CK; high hyperopia; LASIK; myopia;
endothelial cell loss, 81-82, 85, 93-94, 117 PRK; refractive lens exchange
Epi-LASEK, 5 Baïkoff’s foldable anterior chamber phakic IOL for,
epinephrine, 50 151-159
epithelial flap, 5 with bioptics, 184
epithelial ingrowth, 185-186 CK surgical outcomes, 21
ETDRS reading card, 194 compared to myopia, 157
Euler’s theorem, 59 current practice patterns, 8
European Multicenter Trials, 108, 142 definitions, 2
excimer laser technology, 6, 21 high hyperopia, 8
extracapsular cataract extraction (ECCE), 13 phakic IOLs for, 43
prevalence, 2, 3
Fine-Thornton fixation ring, 60 PRL for, 145
foldable phakic IOLs, 47, 108, 151-159, 177, 207-208. refractive outcomes, 113
See also ICL surgical procedures, 6-8
folded ICL, 123 W-to-W length, 121
Food and Drug Administration (FDA) hyphema, 89
Array lens approval, 211 hypoxia, 21
clinical trial for myopia, 117
investigation of the CrystaLens, 194 iatrogenic keratectasia, 5
phakic IOL designs under consideration, 22 I-CARE lens, 171-172
 Index 223

intracorneal ring segments (ICRs), 5, 21 with excimer laser technology, 6

Implantable Contact Lens (ICL) for hyperopia, 6
clinical outcomes, 42 for low and moderate myopia, 1
complications, 17, 39, 182-187 for low hyperopia, 2
considerations, 47 with PRL, 146
design, 100-101 regression rates, 21
efficacy, 127-128 lens deposits, 82, 85
ICL V4 lens, 178, 180, 205 Lens Opacity Classification System (LOCS), 103
insertion of, 72-73 lenticular astigmatism, 58
lens opacity analysis, 129 lidocaine, 48-49, 122
lens preparation, 122-124 light adjustable IOLs, 210
patient satisfaction, 128-129 light emitting diode (LED) sizer, 154
preoperative planning, 121-122 limbal relaxing incisions (LRIs), 58
refractive outcomes, 107-108
STARR posterior phakic IOL, 200 malignant hyperthermia, 53
surgical techniques, 124-128 mean refractive spherical equivalent (MRSE), 163
toric lens, 206 modulation transfer function (MTF), 38
visual acuity, 129-130 multifocal IOLs, 5, 189-190
interface fluid, 187 myopia. See also astigmatism; high myopia; hyperopia
International Society of Refractive Surgery (ISRS), 6 Baïkoff’s foldable anterior chamber phakic IOL for,
intracapsular cataract extraction (ICCE), 13, 153 151-159
intraocular lenses (IOLs), 13, 32, 87, 93. See also phakic with bioptics, 184
IOL (intraocular lens); specific types of lenses clinical trials, 117
intraocular lens rotation, 82-83 compared to hyperopia, 157
intraocular pressure (IOP), 92-93, 99, 167, 183, 183-184 current practice patterns, 6
iridectomy, 156, 180 definitions, 1
iridocyclitis, 117 high myopia. see also phakic IOL (intraocular lens)
iridotomy, 137, 164, 180 anterior chamber evaluation, 25
iris retraction, 82 complications, 15
iris-claw lens, 15-16, 18, 31, 70, 85-87 excimer laser procedures, 21
iris-fixated anterior chamber phakic IOLs, 84-89, 108-109 LASIK and Artisan lens for, 141-142
ischemia of the optic nerve and retina, 39 reducing subepithelial haze, 5
refractive surgery, 1
Kammann, Jochen, 194 risk factors, 146
Kelman, Charles, 171 surgical treatment, 89-90
Kelman-type implant, 15, 110, 167 LASIK for, 75
keratectasia, 4, 21 prevalence, 1-2, 3
keratitis, 69 refractive outcomes, 110-113
keratoconus, 5, 70
keratorefractive surgery, 39, 189 “NAPA” nomogram, 59
k-readings, 40 neodymium:yttrium-aluminum-garnet (Nd:YAG), 137, 147,
180
laser-assisted subepithelial keratectomy (LASEK), 5, 21 Nichamin Modified Fine-Thornton fixation ring, 60
laser flare-cell meter, 31 Nidek Advanced Vision Excimer Laser System, 180
laser in-situ keratomileusis (LASIK). See also corneal night vision, 159, 174
refractive surgery; ICL noncontact specular microscopy, 31
advantages, 26 NuVita MA20 lens, 109, 117, 167, 200
with bioptics, 181-182
challenges, 133 1CU acrylic accommodative IOL, 213-214
complications, 75-76 optic nerve, ischemia, 39
contraindications, 71 optical coherence tomograph scanner, 155
for correcting refractive errors, 199 optical quality, 37-39
efficacy, 3-4, 39 orbital blocks, 49-52
enhancement procedures, 159 Orbscan analysis, 23, 70
224 Index

parabulbar anesthesia, 51-52 bioptics, 42-43

paracentesis, 125-126, 136, 156 clinical outcomes, 42
peribulbar anesthesia, 50-51 necessary measurements, 39-42
peripheral iridectomy, 101-102, 122 wavefront technology, 37
phacoemulsification, 32 preoperative diagnostic testing
phakic IOL (intraocular lens). See also corneal refractive effect on corneal endothelium, 31-32
surgery endothelial cell counts, 29-32
advantages, 39 phacoemulsification and IOLs, 32
as an alternative to keratorefractive surgery, 39 sulcus measurements, 32-33
anesthesia techniques in pseudophakic eyes, 182, 199-201
considerations, 47-48 refractive outcomes
general anesthesia, 52-53 comparison of IOL designs, 107-113, 213
orbital blocks, 49-52 complications, 113-118
topical/intracameral, 48-49 risk factors, 84
anterior chamber angle-supported, 81-84 phakic refractive lens (PRL), 39, 47, 92-93, 108, 145-148,
Artisan phakic IOL, 4 145-148. See also ICL
astigmatism management photic phenomena, 191
patient selection, 58 photorefractive keratectomy (PRK). See also LASEK
treatment options, 5, 59-64 complications, 69
complications, 26, 81, 199 for correcting refractive errors, 199
contraindications, 24 enhancement procedures, 159
future developments with excimer laser technology, 6
accommodative IOLs, 210-216 for hyperopia, 6
anisometropic amblyopia, 205-206 for low hyperopia, 2
foldable lenses, 207-208 for low myopia, 1, 4-5
lens designs, 205 regression rates, 21
light adjustable lenses, 210 risk factors, 4
toric phakic lenses, 206-207 piggyback lens insertion, 7-8, 200
ultrathin lenses, 208-210 pigment dispersion, 82, 85, 92-93, 117
for high hyperopia, 2 pincushion distortion, 43
for high myopia, 1 pleomorphism, 30-31
historical perspectives, 1, 13-18 point spread function (PSF), 37-38
I-CARE, 171-172 polymegathism, 29-32
IOL designs, 22 polymethylmethacrylate (PMMA) lens, 15, 30, 109-110,
iris-fixated anterior chamber phakic IOLs, 84-89 153, 171
Kelman Duet implant, 171-174 polymorphism, 32
optical quality considerations, 37-39 posterior capsular opacity, 7
patient selection posterior capsule opacification (PCO), 13
age factors, 24 posterior chamber (PC), 13, 18
anterior chamber evaluation, 25 posterior chamber phakic IOLs, 89-94
considerations, 21-22 preoperative assessment, corneal refractive surgery, 70-71
corneal evaluation, 25 preoperative consent, corneal refractive surgery, 71
patient education/patient counseling, 25-26 preoperative preparation, corneal refractive surgery, 71
patient history, 22-24 preoperative refraction, 41-42
pupil size, 24-25 presbyopia, 24, 70, 151-159
posterior chamber phakic IOLs, 89-94 progressive refractive abnormalities, 152
postoperative care pseudoexfoliation syndrome, 39
enhancement procedures, 103 pseudophakic patients, 182, 199-201
first visit, 100-102 pupil irregularity, 117
IOP considerations, 99 pupil ovalization, 82, 86-87
long-term considerations, 103 pupil size, 24-25
one month postoperative visit, 102-103 pupillary block, 91-92
one week postoperative visit, 102 pupillary block glaucoma, 108, 117
power calculations pupillary ovalization, 159
 Index 225

Q formula, 193 theoretical vergence formula, 40

Q-value, 37 thermal keratoplasty, 6
ThinOptx Ultrathin IOLs, 208-210
radial keratotomy (RK), 21, 60, 69, 199 Thornton, Spencer, 193-194
refractive lens exchange. See also hyperopia topical/intracameral anesthesia, 48-49
accommodative IOLs, 194-194
advantages, 189 ultra-high frequency scanner, 155
clinical outcomes, 190 ultrasonic A-scan units, 40
clinical studies, 191-192 ultrasound biomicroscopy, 25
complications, 26, 134, 193 ultrathin IOLs, 208-210
contrast sensitivity, 190-191 uncorrected visual acuity (UCVA), 5, 69, 117. See also
historical perspectives, 5-8 BCVA
multifocal IOLs, 189-190 Urrets-Zavalla syndrome, 156
patient selection, 192 uveitis, 39, 82, 86
photic phenomena, 191
postoperative care, 193 Van der Heijde nomogram, 136, 210
preoperative measurements, 192-193 vault classification, 183-184
surgical techniques, 193 viscoelastic, 125, 127, 156
refractive surgery. See corneal refractive surgery Vision Membrane IOLs, 209-210
residual refractive error, 37 visual acuity. See also BCVA; BSCVA; UCVA
retina, ischemia, 39 with angle-supported phakic IOLs, 166
retinal detachment, 5, 7, 94 comparison of IOL designs, 213
retrobulbar blocks, 49-50 ETDRS reading card, 194
rhegmatogenous retinal detachment, 94 flap construction and, 184-185
Ridley, Sir Harold, 13-14 following LASIK, 3-4
rigid gas permeable (RGP) contact lenses, 30 with ICL, 129-130
root mean square (RMS) surface values, 39 loss of, 159
testing, 37-38
scotopic illuminance level, 24 vitreoretinal procedures, 84, 94
secondary images, 39 Vivarte lens, 110, 152-153, 157
SmartLens accommodative IOL, 214-217 Volkova, Eva, 157
Snellen visual acuity, 37
SRK T formula, 193 wavefront technology, 37, 64
STAAR’s intraocular contact lens, 17-18, 100-101 Worst iris-claw lens, 18
strabismus, 206 Worst, J., 167
Strampelli, Benedetto, 13, 167 Worst-Fechner lens, 31, 84-85
Strampelli lens, 13-14 White-to-White length, 121, 154, 193
stromal wound healing, 4-5
subepithelial haze. See haze Zaldivar, Roberto, 42-43, 63, 68, 212
Sub-Tenon’s block, 51-52 ZB 5M lens, 174
sulcus measurements, 32-33 ZB lens, 15-16, 31, 167
surgically induced astigmatism, 83, 87-89 ZSAL-4 lens, 110, 117, 167
ZSAL-4 Plus lens, 174
Zywave, 180
Along with this title, we publish numerous products on a variety of topics. We are sure that you will find the below titles to be
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PHAKIC INTRAOCULAR LENSES: A COMPLETE SURGICAL GUIDE FOR

PRINCIPLES AND PRACTICE
David R. Hardten, MD, FACS; Richard L. Lindstrom, MD; and
Elizabeth A. Davis, MD, FACS
240 pp., Hard Cover, 2004, ISBN 1-55642-640-2,
Order #66402, $179.95
Drs. Hardten, Lindstrom, and Davis have collaborated with
an array of experts to produce Phakic Intraocular Lenses, a
dynamic text concerning one of the newest frontiers in
refractive surgery. This well-referenced text includes multiple
styles of intraocular lenses and locations of implantation, as
well as results, complications, and optics. The authors utilize
a comprehensive, user-friendly format coupled with excellent
illustrations to thoroughly explain this emerging topic.
CORRECTING ASTIGMATISM :
AN OPHTHALMIC MANIFESTO
James P. Gills, MD
256 pp., Hard Cover, 2003, ISBN 1-55642-612-7,
Order #66127, $114.95
A Complete Surgical Guide for Correcting Astigmatism: An
Ophthalmic Manifesto is a comprehensive text dealing with
the surgical correction of astigmatism. Toric IOLs, laser and
incisional techniques, and upcoming toric IOL technology
are examples of the procedures profiled and analyzed.
Extensive outcomes data and thought-provoking case
presentations offer readers the opportunity to analyze proper
procedures on a case-by-case basis.

PRESBYOPIA: A SURGICAL TEXTBOOK

Amar Agarwal, MS, FRCS, FRCOphth
256 pp., Hard Cover, 2002, ISBN 1-55642-577-5, Order #65775, $109.95
This dynamic book not only presents the concepts necessary to understand presbyopia, but also offers the surgical possibilities
for treating the condition. It is the ideal resource for ophthalmologists who currently perform presbyopic treatment as well as those
who desire to move into it. It covers the scleral, corneal, and lenticular modifications to treat presbyopia, dissects each technique,
and explains how to manage complications of each technique.

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