ICL

TM
/ TORIC ICL
TM
STAAR Surgi cal AG
Hauptstrasse 104
P.O. Box 463
CH-2560 Ni dau
Swi tzerl and
Tel +41 32 332 88 88
Fax +41 32 332 88 99
i nfo@staarag.ch
www.staar.com
www.i cl i nfo.i nfo
INTRODUCTION
Welcome to a new era in refractive surgery.
The ICL
TM
and Toric ICL
TM
are posterior chamber,
sulcus located phakic intraocular lenses for
the treatment of myopia, hyperopia and astig-
matism. This manual will help guide you
through the patient selection process, surgical
procedure and follow-up care for your
patients receiving the ICL
TM
and Toric ICL
TM
.
Welcome to the world of High Definition Vision.
TABLE OF CONTENTS
CHAPTER 1 - ICL
TM
/ Toric ICL
TM
Certication Process
I CL
TM
/ Tori c I CL
TM
Certi fi cati on Process
CHAPTER 2 - Product Information
I ndi cati ons for Use
Contrai ndi cati ons
Endothel i al Cel l Densi ty
Lens Materi al
Opti cal Di ameter
CHAPTER 3 - Pre-operative Preparation
Pre-operati ve Exami nati on
Measuri ng Whi te-to-Whi te
Peri pheral I ri dotomy / I ri dectomy (PI )
I CL
TM
/ Tori c I CL
TM
Power Cal cul ati on
Lens Orderi ng
CHAPTER 4 - Marking the Cornea for Toric ICL
Implantation and Pupil Dilation
Marki ng the Cornea
Pupi l Di l ati on
CHAPTER 5 - ICL/ Toric ICL Loading Technique
Requi red I nstruments for Loadi ng and I mpl antati on
I CL
TM
/ Tori c I CL
TM
Handl i ng Precauti ons
Step-by-Step Lens Loadi ng
CHAPTER 6 - Surgical Procedure
Pati ent Preparati on
Anesthesi a
Surgi cal Techni que
Marki ng the Cornea for Tori c I CL
TM
I mpl antati on
Paracentesi s
I nj ecti on of Vi scoel asti c
Cl ear Corneal Temporal I nci si on
I CL
TM
/ Tori c I CL
TM
I nj ecti on
Posi ti oni ng the I CL
TM
Al i gni ng the Tori c I CL
TM
Removal of Vi scoel asti c
Constri cti ng the Pupi l
Post-operati ve Medi cati on
CHAPTER 7 - Post-operative Assessment and
Complication Management
Earl y Post-operati ve Exami nati on (2-4 hours)
Eval uati ng the Vaul t
Routi ne Post-operati ve Exami nati on
Consi derati ons
Power / Si ze
Wound Constructi on
I mproper Loadi ng
Poor I nserti on
Earl y Post-operati ve Compl i cati ons
I OP Spi ke / El evated I OP
I nadequate Vaul t
Excessi ve Vaul t
Traumati c Cataract
Late Post-operati ve Compl i cati ons
Cataract
Decentered I CL
TM
Atypi cal Late Post-operati ve Fi ndi ngs
Pi gment on the I CL
TM
I ri s Transi l l umi nati on
Techni que for I CL
TM
/ Tori c I CL
TM
Removal
Deci si on Tree
Comparati ve Studi es of I CL
TM
and Tori c I CL
TM
10
12
12
12
13
14
16
16
16
18
18
20
20
22
22
23
28
28
28
28
29
29
29
30
31
31
32
32
32
34
34
34
35
35
35
35
36
36
36
36
37
37
37
38
38
38
38
38
39
41
42
ICL
TM
/ TORIC ICL
TM
USERS MANUAL
ICL
TM
/ Toric ICL
TM
Certication Process
ICL
TM
/ TORIC ICL
TM
CERTIFICATION PROCESS
I CL
TM
/ Tori c I CL
TM
certi fi cati on i s a mandatory requi rement for
physi ci ans who are i nterested i n i mpl anti ng the l ens.
Physi ci an certi fi cati on for i mpl antati on of the I CL
TM
i s part of
STAAR Surgi cal s ongoi ng commi tment to excel l ence i n oph-
thal mol ogy. A physi ci an becomes el i gi bl e for certi fi cati on after
attendi ng an offi ci al I CL
TM
/ Tori c I CL
TM
Certi fi cati on Course.
Once el i gi bl e, the physi ci an wi l l compl ete certi fi cati on by suc-
cessful l y sel ecti ng, i mpl anti ng and managi ng hi s/her fi rst surgi -
cal procedures wi th the support of an on-si te STAAR Surgi cal
I CL
TM
/ Tori c I CL
TM
Product Speci al i st.
I nternati onal certi fi cati on courses are part of a two-step cer-
ti fi cati on program. The fi rst step i n the process i s a one-day
course consi sti ng of a four-hour di dacti c presentati on, l ens
l oadi ng l ab, l i ve surgery observati on and exami nati on of post-
operati ve pati ents. The second part of thi s program consi sts
of successful compl eti on of the fi rst surgeri es under the
gui dance of a Product Speci al i st.
The Product Speci al i st wi l l contact the physi ci an to arrange
the l ogi sti cs of the certi fi cati on. Several i mportant factors shal l
be di scussed duri ng thi s i ni ti al contact i ncl udi ng:
Schedul i ng appropri ate surgi cal and cl i ni cal staff trai ni ngs
Schedul i ng pre-surgi cal ti me to revi ew the surgi cal steps
and l ens-l oadi ng procedure
Revi ewi ng a pre-surgi cal checkl i st of the requi red i nstru-
mentati on
Revi ewi ng potenti al I CL
TM
/ Tori c I CL
TM
candi dates for accu-
rate pati ent sel ecti on
Pl ease keep i n mi nd when requesti ng a proctori ng date that
the certi fi cati on usual l y takes up to three days:
Day one trai n staff and revi ew al l necessary surgi cal steps
Day two perform surgery
Day three one-day postoperati ve pati ent revi ew and
answeri ng any remai ni ng questi ons
Addi ti onal l y, peri pheral YAG I ri dotomi es must be performed
one to two weeks pri or to surgery. Al so remember that careful
sel ecti on of pati ents i s cri ti cal to successful certi fi cati on.
The Toric ICL
TM
The ICL
TM
/ Toric ICL
TM
is a posterior chamber
phakic IOL located in
the sulcus
Product Information
Indi cati ons for Use
Contrai ndi cati ons
Endothel i al Cel l Densi ty
Lens Materi al
Opti cal Di ameter
ICL
TM
/ TORIC ICL
TM
USERS MANUAL
10
PRODUCT INFORMATION
Indications for Use
The I CL
TM
(myopi c, hyperopi c and tori c versi on) i s i ndi cated:
- For use i n adul ts 21 to 45 years of age
- Avai l abl e di opter range (0.5 D i ncrements):
ICM
TM
-3.0 D to -23.0 D
ICH +3.0 D to +21.0 D
Toric ICL
TM
-3.0 D to -23.0 D (sphere), +1.0 D to +6.0 D (cylinder)
- Wi th anteri or chamber depth (ACD) of 2.8 mm or greater
and a stabl e refracti ve hi story wi thi n 0.5 D for one year pri or
to i mpl antati on
- I ntended for pl acement i n the posteri or chamber of the
phaki c eye
Contraindications
The I CL
TM
i s not recommended i n pati ents:
Pati ents wi th unstabl e refracti on i n the past 12 months (myopi a
and / or asti gmati sm)
Pati ents who do not fal l i n the range of pre-op myopi a, hyper-
opi a or asti gmati sm as outl i ned i n the i ndi cati ons for use
Pati ents under 21 or over 45 years of age
Pati ents wi th an ACD of l ess than 2.8 mm as measured from
the corneal endothel i um
Pati ents wi th l ow endothel i al cel l count, Fuchs dystrophy or
other corneal pathol ogy
Pati ents wi th a hi story of i ri ti s, uvei ti s, synechi ae, pi gment
di spersi on syndrome, reti nal di sease (other than mani festati on
of myopi c degenerati on), chroni c i ntraocul ar i nfl ammati on,
macul ar degenerati on, i rregul ar asti gmati sm, keratoconus or
cystoi d macul ar edema i n ei ther eye.
Pati ents wi th di abeti c reti nopathy i n ei ther eye
Pati ents wi th gl aucoma or di agnosi s of ocul ar hypertensi on i n
ei ther eye
Pati ents wi th hi story of previ ous i ntraocul ar surgery (i ncl udi ng
refracti ve surgery) i n the eye to be treated
Pati ents who are ambl yopi c or bl i nd i n the fel l ow eye
Pati ents wi th a progressi ve si ght-threateni ng di sease. Pati ents
wi th reti nal fi ndi ngs associ ated wi th pathol ogi cal myopi a are
al l owed.
Pati ents wi th cataract i n ei ther eye or systemi c col l agen
sensi ti vi ty
Pati ents wi th i nsul i n-dependent di abetes
Pati ents who are pregnant or nursi ng
Endothelial Cell Density
The fol l owi ng tabl e i ndi cates the mi ni mum ECD per age group
at ti me of i mpl antati on for three di fferent ACD ranges and i s to
be used as a reference. Thi s tabl e was devel oped usi ng rates
of 2.47%, 2.44%, and 2.15% (the upper 90% confi dence i n-
terval of the average cel l l oss for eyes wi th the speci fi ed ACD)
for the 3.0 mm, 3.2 mm, and 3.5 mm groups, respecti vel y.
I t sets mi ni mum ECD cri teri a as functi ons of age that shoul d
resul t i n at l east 1000 cel l s/mm
2
at 75 years of age. The
pati ents ECD shoul d be moni tored peri odi cal l y; methodol ogy
for determi ni ng cel l densi ty i s at the di screti on of the physi ci an.
Age (years) Minimum ECD Minimum ECD Minimum ECD
ACD 3.0 mm ACD 3.2 mm ACD 3.5 mm
21 - 25 3875 cells/mm
2
3800 cells/mm
2
3250 cells/mm
2
26 - 30 3425 cells/mm
2
3375 cells/mm
2
2900 cells/mm
2
31 - 35 3025 cells/mm
2
2975 cells/mm
2
2625 cells/mm
2
36 - 40 2675 cells/mm
2
2625 cells/mm
2
2350 cells/mm
2
41 - 45 2350 cells/mm
2
2325 cells/mm
2
2100 cells/mm
2
> 45 2075 cells/mm
2
2050 cells/mm
2
1900 cells/mm
2
Lens Material
The I CL
TM
i s l athe manufactured from a pro-
pri etary col l agen copol ymer materi al known
as Col l amer

. The materi al has a refracti ve

i ndex of 1.453 at 35C, a speci fi c gravi ty of
1.21 and durometer hardness (shore A) of
45. The pol ymer materi al absorbs ul travi ol et
radi ati on, wi th l i ght transmi ttance i n the
vi si bl e regi on of the spectrum of approxi -
matel y 90% 5% wi th over 90% of
ul travi ol et radi ati on bl ocked bel ow 387nm
wavel ength. Col l amer

has several unique

advantages. Since the collagen contai ned i n the l ens i s nega-
ti vel y charged, i t repel s l i ke charge parti cl es such as protei ns
and cel l s. As such, the l ens exhi bi ts vi rtual l y no postoperati ve
protei n deposi ti on.
Comparision of RMS values of different IOLs with
a consistent pupil of 4.5 mm (Tracy VFA)
1.2
1.4
1.0
0.8
0.6
0.4
0.2
0
Pre-operative 1 Week Post-operative
0.33
0.6
0.31
0.93
0.29
1.13
1.28
0.33
STAAR
Collamer
STAAR
Silicone
AMO
Sensar
Alcon
SA 60
R
M
S
V
a
lu
e
12
ACD
Corneal Endothelium
Anterior Crystalline Lens
13
Pre-operative Preparation
Pre-operati ve Exami nati on
Measuri ng Whi te-to-Whi te
Peri pheral Iri dotomy / Iri dectomy (PI)
ICL
TM
/ Tori c ICL
TM
Power Cal cul ati on
Lens Orderi ng
ICL
TM
/ TORIC ICL
TM
USERS MANUAL
Col l amer

al so exhi bi ts an i nherent anti -refl ecti ve coati ng

property.The gradual change i n refracti ve i ndex at the surface
of the l ens resul ts i n a si gni fi cant reducti on i n gl are
1
. These
properti es combi ne to provi de a l ens materi al that i nduces
fewer postoperati ve hi gher order aberrati ons than other l ens
materi al s
2
. The I CL
TM
provi des excepti onal qual i ty of vi si on and
bi ocompati bi l i ty for excel l ent l ong-term stabi l i ty wi thi n the eye.
Optical Diameter
The opti cal di ameter vari es wi th the spheri cal power of the
I CL
TM
. The tabl e bel ow i l l ustrates the rel ati onshi p between
opti cal di ameter and power. Due to the magni fi cati on of the
cornea, the effecti ve corneal opti cal zone i s greater than the
actual opti cal di ameter of the I CL
TM
.
Power (D) Optical Diameter (mm) Effective Optical Diameter
at Corneal Plane (mm)*
-3.0 to -12.0 5.50 7.30
-12.5 to -13.5 5.25 6.93
-14.0 to -16.5 5.00 6.62
-17.0 to -23.0 4.65 6.17
*Once i mpl anted i n the eye
1) Ossi pov A. Compari son of i nternal refl ectance patterns of Col l amer

, acryl i c and si l i cone. 1997.

2) Marti n RG, Sanders DR. Hi gher order aberrati ons fol l owi ng i mpl antati on of four fol dabl e l ens desi gns, Presented at: ASCRS 2003.
Collamer

(lens on the
top) reduces lens
surface glare
compared to acrylic.
Acrylic
lenses:
Cellular
(protein)
adherence.
Collamer

lenses:
Free of
cellular
or protein
deposits.
In vitro testing for protein
adherence to acrylic and
Collamer

materals.
Pre-operative Examination
A typi cal comprehensi ve pre-operati ve eye exami nati on shoul d
i ncl ude the fol l owi ng:
Thorough ocul ar hi story
Careful and preci se mani fest and cycl opl egi c refracti on
Vi sual acui ty wi th and wi thout correcti on
Keratometry or corneal topography
Corneal pachymetry
Careful measurement of the ACD (as measured from the
corneal endothelium to anterior surface of the crystalline lens)
Pupi l si ze i n normal and scotopi c condi ti ons
Endothel i al cel l count
I ntraocul ar pressure
Comprehensi ve di l ated sl i t-l amp exam to i ncl ude the reti na
Careful measurement of the horizontal white-to-white distance
Goni scopy
Assessment of the crystal l i ne l ens
Axi al l ength (Bi ometry)
Measuring White-to-White
There are vari ous methods for measuri ng hori zontal whi te-to-
whi te di stance. Accurate measurement of whi te-to-whi te i s
cri ti cal for proper si zi ng of the I CL
TM
. To determi ne the I CL
TM

l ength, a nomogram usi ng whi te-to-whi te and ACD i s uti l i zed.
Physi cal measurement wi th cal i brated cal i pers i s one of the
most rel i abl e methods for obtai ni ng the measurement. The
pati ent shoul d be recl i ned i n the exami nati on chai r, the cornea
anestheti zed, and the measurement taken usi ng magni fi cati on,
such as surgi cal l oupes or an operati ng mi croscope. Thi s el i -
mi nates the potenti al paral l ax experi enced at a sl i t l amp.
Consi der val i dati ng the measurement wi th a corneal topo-
graphy uni t. Eval uate any di screpanci es between measuri ng
devi ces. Someti mes a pterygi um or other anomal y can cause
a di screpancy, as can i mproperl y cal i brated cal i pers. I t i s
essenti al that careful attenti on be taken when obtai ni ng thi s
cri ti cal measurement.
Peripheral Iridotomy / Iridectomy (PI)
One to two weeks pri or to i mpl antati on of the I CL
TM
, i t i s
necessary to perform two peri pheral l aser I ri dotomi es. Peri phe-
ral I ri dotomi es are necessary due to the fol l owi ng reasons:
Upon constri cti on of the pupi l , the I CL
TM
may bl ock the
passage of Aqueous from behi nd the l ens to the anteri or
chamber, causi ng an acute pupi l l ary bl ock
I ncompl ete removal of vi scoel asti c duri ng surgery can cause
a potenti al acute pressure ri se
Peri pheral I ri dotomi es shoul d be performed 1 to 2 weeks pri or
to surgery to al l ow the deposi t and re-absorpti on of the pi g-
ment and the humoral factors of i nfl ammati on. The patency of
the i ri dotomi es shoul d be confi rmed pri or to l ens i mpl antati on.
Experi ence from the US FDA cl i ni cal tri al as wel l as i nternati o-
nal data suggests usi ng a yttri um al umi num garnet (YAG) l aser
for the PI s. I f the surgeon deci des to move to the surgi cal PI
techni que, i t i s recommended that thi s i s onl y done once the
I CL
TM
surgi cal techni que has been mastered. A two-step l aser
procedure, pre-treatment wi th an Argon Laser fol l owed by
Nd:Yag, i s al so a possi bi l i ty. Two PI s shoul d be pl aced supe-
ri orl y, 90 degrees apart, i n the mi d-peri phery. Each PI shoul d
be at l east 1.0 mm i n di ameter. Some experi enced surgeons
choose to perform surgi cal I ri dectomi es al though STAAR
Surgi cal conti nues to recommend YAG PI s pri or to I CL
TM

surgery, especi al l y for the surgeons fi rst cases.
Tips for making PIs:
YAG PI Surgical PI by
Scissors
Surgical PI by
Vitrector
Size and number Approximately 1mm,
2 PIs required.
Require more ex-
perience to control.
Usually range from
1 mm to 2 mm. Only
1 PI required.
If too big, may inter-
fere with vision.
Require more ex-
perience to control.
Usually range from
1 mm to 2 mm. Only
1 PI required.
If too big, may inter-
fere with vision.
Location Keep peripheral
enough to avoid inter-
ference with vision,
but not so peripheral
that they do not
function properly.
PIs should be at least
90 degrees apart
(approximately 10:30
and 1:30 oclock).
Keep peripheral
enough to avoid inter-
ference with vision,
but not so peripheral
that they do not
function properly.
Approximately
12 oclock.
Keep peripheral
enough to avoid inter-
ference with vision,
but not so peripheral
that they do not
function properly.
Approximately
12 oclock.
Permeability Ensure penetration
of the pigment
epithelium.
Double-check full
thickness permeabili-
ty before surgery and
re-YAG if needed.
Ensure penetration
of the pigment
epithelium.
Ensure aspiration of
pigment to avoid IOP
spike after surgery.
Ensure penetration
of the pigment
epithelium.
Ensure aspiration of
pigment to avoid IOP
spike after surgery.
PI done with vitrector
nearly at 12 oclock.
Main incision must be
temporal
PRE-OPERATIVE PREPARATION
Yag-PIs done prior to
surgery at 10:30 and
1:30 oclock
16 17
ACD
Corneal Endothelium
Anterior Crystalline Lens
ICL
TM
/ Toric ICL
TM
Power Calculations
Mani fest or cycl opl egi c refracti on i s requi red to perform the
l ens power and l ength cal cul ati on.
Enter the fol l owi ng requi red data i nto the I CL
TM
/ Tori c I CL
TM

Power Cal cul ati on Software:
Sphere Manifest or cycloplegic
Cylinder Manifest or cycloplegic
Axis Valid range 0 to 180 degrees
K Readings K1 and K2 values
ACD Anterior Chamber Depth, valid range: 1 to 4.5 mm as
measured from corneal endothelium to the crystalline lens.
This value must be equal or greater than 2.8 mm
WTW White-to-White, valid range 10 to 14 mm
CT Corneal thickness in mm
BVD Back Vertex Distance is set at a default of 12.0 mm, but
should be changed if BVD used during refraction differs
Lens Ordering
Send your cal cul ati on pri ntout to your l ocal STAAR Surgi cal
representati ve.
Marking the Cornea for Toric ICL Implantation and Pupil Dilation
Marki ng the Cornea
Pupi l Di l ati on
ICL
TM
/ TORIC ICL
TM
USERS MANUAL
18
MARKING THE CORNEA FOR
TORIC ICL
TM
IMPLANTATION
AND PUPIL DILATION
Marking the Cornea
Pri nt out the i mpl ant di agram to know degree and di recti on
of rotati on of the Tori c I CL
TM
Pri or to taki ng your pati ent to the surgery room, the cornea
shoul d be marked at the sl i t l amp
Anestheti ze the eye wi th topi cal anestheti c drops
Usi ng a cornea marker, mark the cornea at 0 and 180
degrees (sl i t l amp i s useful for thi s)
You can al so use thi s hori zontal mark as a gui de to mark the
eye at the degree to whi ch the Tori c I CL
TM
needs to be
rotated. Some surgeons do thi s step once the pati ent i s i n
the OR
Dilation
A pupi l si ze of 8.0 mm at the ti me of surgery i s suggested.
Pupi l di l ati on shoul d be done pri or to the pati ent enteri ng
the OR
I nsti l l 1 drop of fl urbi profen 1 hour pri or to surgery to mai n-
tai n pupi l di l ati on
Proper pupi l di l ati on i s usual l y achi eved by i nsti l l i ng 1%
tropi cami de and 2.5% neosynephri ne (or 10% i f 2.5% i s
not commerci al l y avai l abl e) every 10 mi nutes for a mi ni mum
of 30 mi nutes and l onger i f necessary
I t i s recommended to conti nue di l ati on drops unti l the pati ent
enters the surgi cal sui te
I f adequate di l ati on i s not achi eved or l oss of di l ati on
occurs, the addi ti on of preservati ve-free i ntraocul ar epi ne-
phri ne at a dosage of 0.1 ml of 1:10000 sol uti on may
enhance di l ati on
Adequate dilation is extremely important. Proceed wi th
extreme cauti on i f the pupi l i s <8 mm
The horizontal axis
can be marked at the
slit lamp
Adequate pupil dilation
is crucial for ICL
TM

surgery
ICL / Toric ICL Loading Technique
Requi red I nstruments for Loadi ng and I mpl antati on
I CL
TM
/ Tori c I CL
TM
Handl i ng Precauti ons
Step-by-Step Lens Loadi ng
ICL
TM
/ TORIC ICL
TM
USERS MANUAL
20
ICL
TM
/ TORIC ICL
TM
LOADING
TECHNIQUE
The procedure must be performed i n a steri l e envi ronment
under control l ed condi ti ons. The fol l owi ng l oadi ng and surgi cal
techni que gui del i nes are recommended by STAAR Surgi cal .
These instructions are supplementary to the Directions For Use.
Required Instruments for ICL
TM
Loading and Implantation
The fol l owi ng i nstruments are necessary for proper l oadi ng
and i nj ecti on of the I CL
TM
:
Operati ng mi croscope
Bal anced Sal t Sol uti on (BSS)
Methyl cel l ul ose-type vi scoel asti c
I CL
TM
l ong-mouth forceps for pl aci ng l ens i nto cartri dge.
Avai l abl e from vari ous suppl i ers
I CL
TM
front-l oadi ng forceps for pul l i ng the l ens through
the cartri dge. Avai l abl e from STAAR Surgi cal
Cartri dge (SFC45 FP) provi ded wi th the l ens
Foam Ti p Pl unger (FTP) provi ded wi th the l ens
Mi croSTAAR i nj ector MSI -PF (push acti on) or MSI -TF (twi st
acti on)
Keratome bl ade for paracentesi s
Di amond or steel bl ade capabl e of 3.0-3.2 mm corneal
i nci si on
I CL
TM
mani pul ator (avai l abl e from several manufacturers)
BSS on a canul a for manual removal of vi scoel asti c
ICL
TM
/ Toric ICL
TM
Handling Precautions
Choi ce of the proper I CL
TM
/ Tori c I CL
TM
si ze shoul d be
careful l y consi dered pri or to surgery
Check the l abel of the package for proper l ens model and
power
Open the package to veri fy the l abel ed di optri c power of
the l ens
Handl e the l ens by the hapti c porti on. Do not grasp the opti c
wi th forceps as thi s coul d potenti al l y l ead to damage to the
smooth anteri or and posteri or opti cal surfaces
Never touch the center of the opti c wi th i nstruments once
the l ens i s pl aced i nsi de the eye. I nadvertent pressure
through the opti c coul d potenti al l y damage the central
crystal l i ne l ens, resul ti ng i n l ens opaci ty
STAAR Surgi cal recommends usi ng onl y the Mi croSTAAR

I nj ector System (Model s MSI -TF and MSI -PF) to i nsert the
I CL
TM
/ Tori c I CL
TM
i n the fol ded state
Required instruments
for ICL
TM
loading and
implantation
The I CL
TM
/ Tori c I CL
TM
shoul d be careful l y exami ned i n the
operati ng room pri or to i mpl antati on
The I CL
TM
/ Tori c I CL
TM
shoul d not be exposed to any sol u-
ti ons other than the normal l y used i ntraocul ar i rri gati ng
sol uti ons (eg, i sotoni c sal i ne, BSS, vi scoel asti c)
Keep the I CL
TM
/ Tori c I CL
TM
moi st. I t i s recommended that
the l oaded I CL
TM
/ Tori c I CL
TM
be pl aced i n steri l e BSS pri or
to i mpl antati on to prevent dehydrati on
The ICL
TM
/ Tori c ICL
TM
shoul d be handl ed careful l y. No
attempt shoul d be made to reshape or cut any porti on of the
l ens. Do not appl y undue pressure to the I CL
TM
/ Tori c I CL
TM

opti cal porti on wi th a sharp obj ect because thi s coul d
perforate the opti c
The i ntended l ocati on of the I CL
TM
/ Tori c I CL
TM
i s behi nd the
i ri s wi thi n the posteri or chamber and i n front of the anteri or
capsul e of the crystal l i ne l ens
Hydroxypropyl methyl cel l ul ose (HPMC) vi scoel asti c i s recom-
mended for use wi th the I CL
TM
The l ong-term effects of phaki c i ntraocul ar l ens i mpl antati on
have not been determi ned. Therefore, physi ci ans shoul d conti -
nue to moni tor pati ents postoperati vel y on a regul ar basi s.
Step-by-Step Lens Loading
Loadi ng of the I CL
TM
i s a cri ti cal component of the overal l
procedure and shoul d be performed under the operati ng
mi croscope pri or to maki ng any i nci si ons. The del i very of the
i mpl ant i nto the anteri or chamber i s l argel y dependent on the
preci se and careful l oadi ng of the I CL
TM
.
Steps to l oad the I CL
TM
:
Open the pouch of the i nj ector and pl ace the steri l e i nj ector
on a steri l e fi el d
Open the foi l pouch and the i nner pouch contai ni ng the cart-
ri dge and pl ace the inner sterile cartridge tray on a steri l e
fi el d. Open the cartri dge tray by pul l i ng up where i ndi cated
Open the outer pouch of the Foam Ti p Pl unger (FTP) and
transfer the inner sterile pouch to a steri l e fi el d. Open the
i nner pouch and remove the FTP and hol der. The base of the
FTP protrudes from the back of the hol der
Open the l ens vi al by l i fti ng up the tab on top of the al umi -
num cap and pul l i ng i n a downward di recti on
Place the FTP into the vial so that it will become well hydrated
ICL
TM
front-loading
forceps
22 23
Fi l l the cartri dge fi rst wi th BSS fol l owed by a parti al fi l l wi th a
methyl cel l ul ose-type vi scoel asti c, creati ng a trai l out the
back of the cartri dge bay. Thi s combi nati on mi ni mi zes
fri cti on between the I CL
TM
and the cartri dge wal l s
Gentl y remove the I CL
TM
from the vi al usi ng the FTP and
pl ace the l ens on the back porti on of the cartri dge. Pl ace the
FTP back i nto the vi al for further hydrati on
Grasp the I CL
TM
wi th the long-mouth forceps and i nspect i t
under the operati ng mi croscope to i denti fy and veri fy the
correct ori entati on of the l ens. The footpl ate marks on the
l eadi ng ri ght and trai l i ng l eft hapti c i ndi cate that the correct
(convex) si de of the I CL
TM
i s faci ng up. The other center
marks are used to gui de al i gnment duri ng the l oadi ng of the
l ens i nto the i nj ector cartri dge and for axi s ori entati on whi l e
i mpl anti ng the Tori c I CL
TM
Wi th the cartri dge hel d i n one hand and the forceps hol di ng
the I CL
TM
i n the other, pl ace the l ens i n the cartri dge bay.
I ntroduce the I CL
TM
i nto the cartri dge bay so that the l ong
axi s of the l ens i s posi ti oned under each si derai l of the cart-
ri dge. Thi s usual l y requi res starti ng one l ong edge of the
I CL
TM
under one rai l and rol l i ng the wri st to posi ti on the
opposi te si de of the I CL
TM
under the opposi ng rai l
Cl ose the j aws of the front-loading forceps and i nsert them
i nto the barrel from the front of the cartri dge. Advance the
forceps through the cartri dge unti l the j aws are about to
contact the l eadi ng edge of the I CL
TM
Open the j aws of the forceps and grasp the footpl ate of the
I CL so that the l ens posi ti oni ng mark i s al i gned wi th the j aws
Sl owl y pul l the l ens i nto the barrel whi l e movi ng the cartri dge
i n the opposi te di recti on. Observe the l ens posi ti oni ng marks
on ei ther si de of the I CL
TM
opti c to confi rm al i gnment as you
advance the I CL
TM
. Conti nue thi s process unti l the I CL
TM
i s
posi ti oned wi thi n the cartri dge so that i ts l eadi ng edge i s
wi thi n 2 mm of the end of the cartridge. Release the ICL
TM

and remove the forceps
Any air bubbles should be evacuated from the loaded cart-
ridge with methylcellulose-type viscoelastic injected into the
tip of the cartridge using the cannula to backfill the cartridge
Insert the FTP into the injector by placing the FTP back into
its holder (foam side into the holder) and introducing the base
of the FTP into the injector (the vertical tab of the holder is not
intended to be snap-locked into the notch of the injector).
While holding the tab in place, advance the injector plunger
until the ball end of the FTP interlocks with the injector. A click
can be felt and heard when the plunger is properly secured.
Retract the injector plunger fully. The FTP will remain locked
in place. Remove the holder by sliding it back out of the front
of the injector
Slide the fully loaded lens cartridge into the front of the injec-
tor and snap-lock the vertical tab into position
Advance the plunger until it is in contact with the lens. The
final lens position should be within approximately 1 mm of the
end of the cartridge
Inspect the lens orientation under the operating microscope.
The clear funnel of the cartridge enables identification of the
center marks on each side of the optic. These marks should
be visible at the 12 oclock position and be in straight align-
ment down the shaft. If there is misalignment or improper
orientation, the ICL may be twisted and should be injected
into the cartridge tray and the loading process repeated
The fully assembled injector is placed tip down into a con-
tainer of BSS to maintain lens hydration. The maximum
recommended time for the loaded ICL
TM
to remain in the injec-
tor prior to surgery is 1-2 minutes
Note that there are two types of injectors available, a twist
type (MSI-TF) and plunger type (MSI-PF). The twist type
offers a more controlled injection but requires a two-handed
technique. The plunger style injector can be operated with
only one hand and the fellow hand can be used to stabilize
the globe. Either injector can produce the desired outcome
and is a matter of surgeon preference
The markings on the
footplates indicate the
correct orientation of
the ICL
TM
and the Toric
ICL
TM
(picture shows
Toric ICL
TM
)
24 25
Surgical Procedure
Pati ent Preparati on
Anesthesi a
Surgi cal Techni que
ICL
TM
/ TORIC ICL
TM
USERS MANUAL
Intraoperative marking
of the exact alignment
axis for the Toric ICL
TM
Paracentesi s
Empl oyi ng a temporal approach, two 1-mm paracentesi s
i nci si ons are fashi oned at 12 ocl ock and 6 ocl ock. Stay
shal l ow and do not penetrate too far. Avoi d i nadvertent touch
or perforati on of the anteri or l ens capsul e. Two paracenteses
are recommended for I CL
TM
mani pul ati on. I t i s di ffi cul t to make
the paracentesi s once the mai n i nci si on has been made due
to the eye becomi ng soft.
I nj ecti on of Vi scoel asti c
An HPMC-type vi scoel asti c i s preferred due to i ts ease of
removal and the l ow resi stance offered to the unfol di ng of the
I CL
TM
. Publ i shed reports i ndi cate that hyal uroni c-aci d-type
vi scoel asti cs may i nterfere wi th fi brobl ast prol i ferati on of the
anteri or capsul e and coul d cause l ong-term effects not yet
known
1
. Addi ti onal l y, the use of hi gher mol ecul ar wei ght vi s-
coel asti c agents can cause prol onged unfol di ng ti me that may
prevent the l ens from unfol di ng, requi ri ng removal and repl a-
cement, or may i nterfere wi th the posi ti oni ng of the i mpl ant.
The vi scoel asti c cannul a ti p shoul d not extend more than 1 mm
beyond the wound. The vi scoel asti c i s i nj ected unti l the eye i s
moderatel y fi rm; however, do not overfi l l the chamber. I t shoul d
be possi bl e to vi ew the vi scoel asti c chai ns throughout the fi l l .
I t i s i mportant to i nsert the cannul a past the i nner corneal
wound margi n to avoi d vi sco-di ssecti on of Descemets mem-
brane and endothel i al detachment. I t i s advi sabl e to avoi d
i nj ecti ng vi scoel asti c posteri or to the I CL
TM
because there i s no
access to aspi rate or i rri gate thi s area once the I CL
TM
has been
posi ti oned.
Cl ear Corneal Temporal I nci si on
The temporal approach provi des i deal exposure for a l evel
worki ng pl ane and avoi ds a posteri or-angl ed entry. The cl ear-
corneal i nci si on shoul d have a chord l ength of 3.0 to 3.2 mm
wi th a 2.0 mm tunnel and be made on a paral l el pl ane to the
i ri s. Thi s approach avoi ds touchi ng of the crystal l i ne l ens or
the corneal endothel i um and provi des adequate room for the
l ens i nj ector and a secure sel f-seal i ng cl osure. Addi ti onal
vi scoel asti c may be i nj ected after compl eti on of the i nci si on to
mai ntai n the deep archi tecture of the anteri or chamber. Once
agai n, do not overfi l l the chamber.
SURGICAL PROCEDURE
Patient Preparation
I CL
TM
surgery shoul d be performed i n a steri l e surgi cal envi -
ronment under control l ed condi ti ons. A steri l e fi el d shoul d be
created by usi ng a standard preparati on and drape appropri a-
te for i ntraocul ar surgery.
Anesthesia
Topi cal anesthesi a i s typi cal l y used. The use of i ntracameral
l i docai ne i s controversi al (i ntracameral l i docai ne has been
associ ated wi th parti al l oss of mydri asi s, whi ch i s contrai ndi ca-
ted for the procedure). Peri bul bar, retrobul bar, and/ or general
anesthesi a may al so be used. I f usi ng retrobul bar anesthesi a,
pl ease remember that the forward pressure associ ated wi th
retrobul bar anesthesi a may decrease the ACD, resul ti ng i n
di ffi cul ty and someti mes i nabi l i ty to i nsert the I CL
TM
.
Topi cal anesthesi a may be obtai ned wi th the fol l owi ng topi cal
agents j ust pri or to surgery:
0.75% bupi vi cai ne
0.5% tetracai ne
2.0% l i docai ne
Preoperati ve sedati on i s suggested. I ntravenous access
shoul d be establ i shed wi th sedati on appropri ate for pati ent
comfort. The i ntended l evel of sedati on resul ts i n a consci ous,
cooperati ve, and comfortabl e pati ent. Li ght i nduced sl eep wi th
the accompanyi ng ri sk of uncontrol l ed awakeni ng shoul d be
avoi ded. Oral sedati ves may al so be useful , but may not be as
predi ctabl e as i ntravenous sedati ves.
Surgical Technique
The I CL
TM
surgi cal techni que contai ns many el ements fami l i ar
to cataract surgeons. The steps descri bed bel ow requi re
exact executi on to achi eve opti mal outcomes.
Marki ng of the Cornea for Tori c I CL Al i gnment
I f the target axi s was not marked at the sl i t l amp, the pre-op
corneal marki ng of the hori zontal axi s shoul d be used as a
reference to mark the exact axi s to whi ch the Tori c I CL
TM
wi l l
be al i gned accordi ng to the Tori c I CL
TM
Ori entati on Di agram.
TM
1) Ossi pov A. Compari son of i nternal refl ectance patterns of Col l amer

, acryl i c and si l i cone. 1997.

28 29
The central optic of the
ICL
TM
is considered a
no-touch zone
The Toric ICL
TM
is
custom-made to the
patients refraction and
needs to be rotated
according to the dia-
gram provided by the
software at maximum
22 degrees
I CL / Tori c I CL I nj ecti on
The l oaded I CL
TM
i s brought i nto the surgi cal fi el d and the ti p
of the cartri dge i s i nserted i nto the cl ear corneal wound. The
ti p of the cartri dge shoul d extend j ust beyond Descemets
membrane.
Once the ti p i s i n proper posi ti on (bevel down) and the i nj ector
i s stabi l i zed, the I CL
TM
shoul d be sl owl y i nj ected i nto the
anteri or chamber usi ng an advance-and-pause techni que.
Thi s techni que, someti mes referred to as a tappi ng moti on,
al l ows the I CL
TM
to gradual l y exi t the ti p of the i nj ector and
unfol d i n a sl ow and control l ed manner.
To avoid inadvertent touch of the crystalline lens, do not attempt
to di rect the l eadi ng footpl ates of the I CL
TM
under the i ri s.
As the I CL
TM
unfol ds, i t i s necessary to vi sual i ze the l eadi ng
ri ght footpl ate mark to ensure proper ori entati on of the I CL
TM
.
I f you do not vi sual i ze the footpl ate l andmark, STOP and rotate
the cartri dge unti l proper ori entati on i s achi eved, then conti nue
i nj ecti ng. I f the l andmark i s sti l l not vi sual i zed, STOP. Remove
the I CL
TM
al ong wi th the cartri dge, rel oad, and start the
i nj ecti on agai n. Remember, as l ong as the I CL
TM
remai ns i n the
cartri dge, you sti l l have control of the i mpl antati on process.
When one hal f to three fourths of the I CL
TM
has exi ted the i n-
j ector, a sl ow unfol di ng of the I CL
TM
wi l l occur. I f the I CL
TM
has
not started to unfol d at thi s poi nt, pause and al l ow the l eadi ng
footpl ates to unfol d before i nj ecti ng the remai ni ng porti on of
the i mpl ant. I f the I CL
TM
i s i nj ected compl etel y i nto the anteri or
chamber before the front footpl ates unfol d, the l ens can pre-
sent upsi de down, whi ch wi l l requi re removal , i nspecti on, and
rei nserti on. The unfol di ng of the I CL
TM
shoul d be symmetri cal
al ong the l ong axi s of the i mpl ant.
To ensure the anteri or-posteri or ori entati on of the I CL
TM
wi thi n
the anteri or chamber, any spi ral i ng of the i mpl ant as i t l eaves
the cartri dge must be neutral i zed by counterrotati on of the
i nj ector by the surgeon.
TM TM
Posi ti oni ng the I CL
Once the I CL
TM
i s si tuated i n the anteri or chamber, addi ti onal
vi scoel asti c i s i nj ected over the I CL
TM
to deepen the cham-
ber and di rect the i mpl ant posteri orl y. I nj ect vi scoel asti c unti l
the i ri s-l ens di aphragm shi fts backward. The I CL
TM
must now
be reposi ti oned posteri or to the i ri s pl ane. The paracentesi s
i nci si ons are used to provi de access for the I CL
TM
mani pul ati on
i nstrument. The di stal or nasal footpl ates shoul d be posi ti oned
fi rst. I f any di ffi cul ty wi th pupi l si ze or posi ti oni ng occurs, thi s
wi l l l eave the footpl ates cl osest to the temporal i nci si on avai l a-
bl e for easi er removal of the I CL
TM
.
When working inside the eye, the optical zone of the ICL
TM

should be considered the no touch zone. Al l i nstruments
wi thi n the anteri or chamber shoul d be kept to the peri pheral
area outsi de of the opti cal zone of the I CL
TM
. Wi th the I CL
TM

mani pul ator i n contact wi th the peri pheral part of the foot-
pl ate, the proper moti on i s gentl e posteri or pressure combi ned
wi th a sl i ght rotati on of the i nstrument wi th the fi ngers at one
cl ock-hour or l ess. Once the fi rst footpl ate i s under the i ri s,
the maneuver i s repeated wi th each of the remai ni ng foot-
pl ates unti l al l are posteri or to the i ri s pl ane. Rotati on of the
I CL
TM
i s to be avoi ded once the I CL
TM
i s posi ti oned behi nd the
i ri s. Once posi ti oned behi nd the i ri s, subtl e adj ustments are
achi eved by mani pul ati on on the l ens body between the foot-
pl ate and opti c. Never depress the opti c i tsel f.
Al i gni ng the Tori c I CL
Posi ti on the Tori c I CL
TM
at the proper axi s accordi ng to the
di agram / corneal marki ngs (maxi mum rotati on 22 degrees).
Al ways mani pul ate on the hapti c or body of the l ens, never
on the opti cal zone.
TM
TM
30 31
180 0
Removal of Vi scoel asti c
I rri gati ng the anteri or chamber wi th BSS on a 27-gauge
cannul a wi th sl i ght i nci si onal pressure i s general l y suffi ci ent
to fl ush methyl cel l ul ose from the eye. Bi manual i rri gati on and
aspi rati on i s al so effecti ve; however, standard automated i rri -
gati on and aspi rati on ri sk di sl ocati ng the I CL
TM
and shoul d be
avoi ded. I ri s prol apse and trampol i ni ng of the i mpl ant may al so
occur wi th standard automated i rri gati on. Once the vi sco-
el asti c has been removed, Tori c I CL
TM
al i gnment must be
reconfi rmed.
Constri cti ng the Pupi l
Once the footpl ates are vi sual l y confi rmed to be posteri or to
the i ri s, the l ens i s posi ti oned properl y and al l of the vi scoel as-
ti c has been removed, the pupi l i s pharmacol ogi cal l y constri c-
ted wi th Mi ochol

. Mi ochol

i s preferred to Mi ostat

due to the
l ower ri sk of ci l i ary spasm, whi ch can cause pai n and prol ong
vi sual recovery due to i nduced myopi a. Once the vi scoel as-
ti c i s removed and the pupi l has constri cted, some surgeons
i nj ect i ntracameral anti bi oti cs. At thi s poi nt PI s shoul d be
checked for patency. The wound shoul d then be tested to
confi rm a sel f-seal i ng cl osure.
Post-operati ve Medi cati on
STAAR Surgi cal recogni zes a typi cal postoperati ve regi me may
i ncl ude topi cal anti bi oti c and appl i cati on of anti -i nfl ammatory
medi cati ons fol l owi ng surgery. Some surgeons wi l l al so use
a steroi d drop. The pati ent shoul d conti nue the medi cati ons
usi ng the standard post-operati ve regi me. Typi cal l y, anti bi oti c
4 ti mes a day for 1 week, the anti -i nfl ammatory three to four
ti mes a day on the fi rst post-operati ve day and, i f used, the
steroi d drops four ti mes a day, taperi ng off over a two- to
three-week schedul e.
Postoperative Assessment and Complication Management
Earl y Postoperati ve Exami nati on (2-4 hours)
Eval uati ng the Vaul t
Routi ne Postoperati ve Exami nati on
Consi derati ons
Power / Si ze
Wound Constructi on
Improper Loadi ng
Poor Inserti on
Earl y Postoperati ve Compl i cati ons
IOP Spi ke / El evated IOP
Inadequate Vaul t
Excessi ve Vaul t
Traumati c Cataract
Late Postoperati ve Compl i cati ons
Cataract
Decentered ICL
TM
Atypi cal Late Postoperati ve Fi ndi ngs
Pi gment on the ICL
TM
Iri s Transi l l umi nati on
Techni que for ICL
TM
/ Tori c ICL
TM
Removal
ICL
TM
/ TORIC ICL
TM
USERS MANUAL
32
Early Postoperative Exam (2-4 Hours)
I OP
- I OP i s checked i n thi s earl y post-operati ve exam because
PI s may not be patent, vi scoel asti c may be trapped i n the
PI s or vi scoel asti c may be retai ned i n the Aqueous
Sl i t l amp exami nati on to assess:
- Wound seal i ng
- Centrati on of the i mpl ant
- I nfl ammati on
- Vaul t of the I CL
TM
- Anteri or chamber confi gurati on
Evaluating the Vault
The vaul t i s the di stance from the posteri or surface of the
I CL
TM
to the anteri or surface of the crystal l i ne l ens. The gener-
al l y accepted range of vaul t of an I CL
TM
once i mpl anted i s
0.5 to 1.5 corneal thi ckness. Thi s subj ecti ve measurement
may be esti mated at the sl i t l amp by vi sual l y compari ng the
rel ati ve corneal thi ckness to the space observed between the
anteri or surface of the crystalline lens to the posterior surface of
the ICL
TM
.
The vaul t i s best vi ewed usi ng a thi n opti c secti on wi th an
opti c / l i ght source angl e of 30 to 45 degrees. The focus i s
al ternated posteri or to the vaul t area and anteri or to the cor-
neal thi ckness to compl ete the compari son and measurement.
The vaul t may al so be obj ecti vel y measured usi ng a vari ety of
avai l abl e i nstruments.
Routine Postoperative Examination
An uncompl i cated case wi l l general l y fol l ow a 1-day, 1-week,
1-month, and 1-year postoperati ve eval uati on schedul e.
Appropri ate testi ng i ncl udes:
Di stance and / or near vi sual acui ty
Refracti on
Once in the eye, an
appropriately sized ICL
TM

provides safe distance
from the endothelium
and the crystalline lens
Sl i t l amp exam to eval uate:
- Posi ti on / centrati on of i mpl ant
- Vaul ti ng of i mpl ant
- Anteri or chamber confi gurati on
- Anteri or chamber i nfl ammati on
- Eval uati on of crystal l i ne l ens
I OP
Endothel i al cel l count (may be done at the one year exam.
Some surgeons i ncl ude a fundus and reti nal exam as part of
routi ne annual care)
Considerations
- Power and Size
I t i s cri ti cal that care be taken i n the subj ecti ve measure-
ments requi red for proper power and si zi ng of the I CL
TM
.
As wi th corneal refracti ve surgery, a ski l l ed techni ci an shoul d
be performi ng the routi ne refracti ons and measurements.
When measuri ng whi te-to-whi te, i t i s i mportant to compare
physi cal measurements (cal i per as descri bed i n previ ous
secti ons) wi th topographi cal measurements and i nvesti gate
l arge di screpanci es. Addi ti onal l y, i t i s cri ti cal to cal i brate the
cal i per to ensure accurate measurement.
- Wound Construction
Proper wound constructi on i s cri ti cal to successful i mpl an-
tati on and postoperati ve recovery. The angl e of the i nci si on
shoul d be paral l el to the i ri s pl ane. I f the i nci si on i s angl ed
posteri orl y, i nadvertent touchi ng and / or penetrati on of the
crystal l i ne l ens duri ng wound constructi on may occur. I f thi s
occurs, cancel the I CL
TM
surgery and perform cl ear-l ens
extracti on wi th I OL i mpl antati on.
Proper seal i ng of the wound i s al so cri ti cal to avoi d post-
operati ve i ntraocul ar i nfecti on. I f the wound i s not properl y
constructed, i ri s prol apse i s more l i kel y.
- Improper Loading
I CL
TM
s that are not l oaded properl y may be twi sted i n the
cartri dge. Duri ng i nj ecti on i nto the chamber, the i mpl ant may
exi t i n an uncontrol l ed manner and may tear or be i nverted
wi th the convex si de down. Ei ther of these fl awed l oadi ngs
and i nj ecti ons may requi re I CL
TM
removal and re-i nserti on i n
the prescri bed manner.
The ICL
TM
vault is ideal if
between 0.5 to 1.5
corneal thickness
POST-OPERATIVE
ASSESSMENT AND
COMPLICATION MANAGEMENT
34 35
- Poor Insertion
I nserti on of the I CL
TM
can produce compl i cati ons i n several
i nstances:
I nserti ons that proceed too qui ckl y and do not al l ow the
l eadi ng footpl ates to unfol d may cause the i mpl ant to be
i nverted wi th the convex si de down
- To prevent thi s compl i cati on, pause duri ng the i nserti on
when the I CL i s 50% to 75% out of the ti p, unti l the front
footpl ates open and the correct ori entati on i s veri fi ed
The I CL
TM
may open or unfol d i n an unsymmetri cal manner
wi th one footpl ate openi ng earl i er, whi ch causes the i m-
pl ant to begi n a turn i n one di recti on. I f conti nued and not
corrected, the I CL
TM
may i nvert
- To correct thi s i nserti on, you can rotate the i nj ector to a
posi ti on where the i mpl ant wi l l have the l eadi ng footpl ates
i n proper posi ti on
Early Postoperative Complications
- IOP Spike / Elevated IOP
I OP el evati on shoul d be treated medi cal l y. Di agnosi s of the
cause of the IOP elevation should guide the user in the proper
management. Pl ease see the Deci si on Tree at the end of
thi s manual . Topi cal and / or oral I OP-l oweri ng agents may
be consi dered. The most common factors contri buti ng to
IOP el evati on after ICL
TM
i mpl antati on i ncl ude the fol l owi ng:
Retai ned vi scoel asti c i n the anteri or chamber
(most common)
Non-permeabl e PI s
Bl ocked PI s
Undersi zed PI s
Oversi zed I CL
TM
(l east common)
I f l arge amounts of vi scoel asti c are l eft i n the eye, burpi ng of
the mai n i nci si on may hel p, as wel l as further i rri gati on and
aspi rati on.
I f PI s are not functi oni ng properl y, revi si on of these openi ngs
usi ng the YAG l aser wi l l al l ow pressure to return to normal
l evel s and avoi d pupi l l ary bl ock and associ ated compl i cati ons.
I f the l ens i nserted i s l onger than requi red for the anatomy of
the eye, overvaul ti ng of the l ens may occur, wi th or wi thout
i ncreased I OP (refer to the Excessi ve Vaul t secti on bel ow).
- Inadequate Vault
The appearance of a l ow vaul t wi thi n the fi rst post-operati ve
hours i s not unusual . The vaul t may i ncrease wi thi n the next
post-operati ve days and thi s shoul d be confi rmed at a l ater
stage. Late or earl y i nadequate vaul t al one i s not a compl i ca-
ti on. The deci si on whether or not to remove or exchange for
a l onger l ens shoul d be based on i ndi vi dual surgeon experi -
ence al though STAAR Surgi cal does not recommend remo-
vi ng or exchangi ng the l ens unl ess progressi on or cl i ni cal l y
si gni fi cant l oss of BSCVA has been di agnosed.
- Excessive Vault
I f the l ens i nserted i s l onger than requi red for the anatomy of
the eye, overvaul ti ng of the l ens may occur. It i s recommend-
ed to l eave thi s l ens i n pl ace unl ess the pati ent i s symptoma-
ti c or i f the vaul t i s excessi ve enough to potenti al l y compro-
mi se the angl e or the pati ents vi si on. I f the pati ent exhi bi ts
el evated I OP wi th anteri or di spl acement of the i ri s, narrowi ng
of the angl e and shal l owi ng of the anteri or chamber, i n the
presence of ful l y worki ng I ri dectomi es (i .e. once pupi l l ary
bl ock due to non ful l y functi oni ng PI s and / or remai ni ng
vi sco has been rul ed out), removal of the I CL
TM
and repl ace-
ment wi th a shorter l ength l ens i s recommended.
Experi ence from i nternati onal surgeons advocates di l ati on of
the pati ent i f an earl y post-operati ve I OP spi ke occurs i n the
presence of hi gh vaul t. Thi s wi l l assi st i n the di fferenti al di ag-
nosi s between true pupi l l ary bl ock due to non-worki ng PI s /
remai ni ng vi sco versus true oversi zed I CL
TM
.
3

- Traumatic Cataract
I n case of si gni fi cant i ntraoperati ve trauma to the crystal l i ne
l ens, the pati ent shoul d be eval uated and cl i ni cal data
obtai ned for I OL cal cul ati on. Penetrati on of the anteri or
capsul e i s rare, however, shoul d thi s occur, the surgeon
shoul d convert to cl ear-l ens extracti on wi th IOL i mpl antati on.
Anteri or capsul ar touch may occur whi l e tucki ng the foot-
pl ates of the i mpl ant. I f the rul e of no crossi ng of the opti c
i s observed, these smal l opaci ti es shoul d be peri pheral i n
l ocati on and not vi sual l y si gni fi cant.
3) Pl ease refer to the Deci si on Tree on page 40
36 37
Late Post-operative Complications
- Cataract
A shal l ow vaul t, one-fourth of the corneal thi ckness (~150
mi crons) or l ess, shoul d be moni tored cl osel y for devel op-
ment of anteri or capsul ar haze. Shal l ow vaul t may be one
contri buti ng factor for the devel opment of l ate anteri or
subcapsul ar opaci ty. I n the absence of opaci ti es and / or
l oss of vi sual acui ty, shal l ow vaul t al one does not necessari l y
necessi tate I CL
TM
exchange.
Shal l ow vaul t shoul d be moni tored peri odi cal l y. STAAR
Surgi cal recommends l eavi ng the l ens i mpl anted unl ess
progressi on of the opaci ty and / or l oss of BSCVA has been
di agnosed.
- Decentered ICL
TM
Decentrati on of the I CL
TM
has been extremel y rare. Shoul d a
decentered I CL
TM
occur, an eval uati on of the angl e to confi rm
the posteri or posi ti oni ng of al l footpl ates shoul d be done.
I f the I CL
TM
requi res reposi ti oni ng, care shoul d be taken to
avoi d contact wi th the anteri or surface of the crystal l i ne l ens.
The reposi ti oni ng shoul d take pl ace i n a surgi cal envi ronment
usi ng an operati ng mi croscope.
Atypical Late Post-operative Findings
- Pigment on the ICL
TM
Wi th the Iri dotomy creati on one or two weeks pri or to surgery,
pi gment movement i n the anteri or chamber i s l i kel y to hap-
pen. I n most cases, i t i s sel f-l i mi ti ng and rarel y reaches a l e-
vel of cl i ni cal si gni fi cance. One may observe pi gment on the
anteri or surface (thi ckest peri pheral porti ons of the myopi c
opti cs) and more often on the posteri or surface. I f pi gment
di spersi on i s si gni fi cant, the eye shoul d be eval uated for
si gns of secondary gl aucoma. I n rare cases of conti nui ng
pi gmentary di spersi on wi th subsequent I OP i ncrease, the
I CL
TM
may need to be removed.
- Iris Transillumination
I nadequate posi ti on of the I CL
TM
footpl ate may be correl ated
to i ri s transi l l umi nati on defect. Careful pl acement techni que
combi ned wi th correct si zi ng of the I CL
TM
shoul d mi ni mi ze
thi s occurrence.
38 39
Technique for ICL
TM
/ Toric ICL
TM
Removal
The I CL
TM
may be removed, i f i ndi cated, i n a control l ed and
atraumati c manner.
The eye i s di l ated usi ng the same medi cati ons and ti mi ng as
i n the ori gi nal surgery:
- Drops i nsti l l ed a mi ni mum of 3 ti mes wi th the fol l owi ng
topi cal medi cati ons at 10-mi nute i nterval s unti l an 8mm pupi l
i s achi eved:
- 1% tropicamide
- 2.5% neosynephrine
The ori gi nal paracentesi s and i nci si on may be used to
access the anteri or chamber
The I CL
TM
i s el evated by use of an HPMC-type vi scoel as-
ti c on a standard cannul a di rected through the paracentesi s
i nci si on at the central edge of the i mpl ant. A sl ow, control l ed
appl i cati on of vi scoel asti c wi l l fl ow beneath the I CL
TM
and
i ncrease the vaul t, whi ch may ease the removal
Through the mai n i nci si on, the I CL
TM
mani pul ator i s used wi th
a reverse techni que to bri ng the proxi mal footpl ate i nto the
anteri or chamber above the i ri s
The tucker i s pl aced beneath the I CL
TM
between the foot-
pl ate and opti c and the i mpl ant footpl ate i s pul l ed to the
i nci si on si te
Once a footpl ate i s pul l ed though the i nci si on and exposed,
the front l oadi ng forceps can grasp thi s area and move the
i mpl ant out through the i nci si on
Early post-op exam (3-6 hours after surgery)
shows high IOP (>30-40 mmHg) & high vault (>1.5 corneal thickness)
DECISION TREE
41
PUPIL DILATION
Cyclopentolate +
Phenylephrine +
topical IOP lowering +
oral Acetazolamide
Widen or
new PI 1-2 mm
2
.
Narrow window to do
the PI, pupillary block
will start as soon as
pupil constricts
beyond the edge
of the ICL
Pupillary block
due to PIs
too small /
too peripheral,
not fully permeable
IOP normal
+ vault normal
Keep dilation
+ IOP lowering drops
+ oral Acetazolamide.
Check at 24h,
usually IOP normal,
if IOP high then I / A.
Pupillary block
due to Viscoelastic
retention
in posterior chamber
IOP high
+ vault normal
Keep dilation until
exchange / explant.
Usually done after
1 week, eye more
quiet and allows for
conrmation of Dx.
Oversized ICL
IOP normal
+ vault high (>1.5 CT)
Keep dilation
+ antihypertensive
med until explant /
exchange within
rst 24h.
No Pilocarpine!
Oversized ICL
+ angle closure
IOP high
+ vault high (>1.5 CT)
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.
0
7

0
.
3
4
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0
.
1
4

0
.
2
7
-
0
.
1
6

0
.
4
1
0
.
0
5

0
.
4
6
-
0
.
5
0

0
.
9
8
-
2
.
0
0

2
.
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6
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0
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8
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-
0
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7
8

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8
7
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R
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-
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6
3

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o

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3
8
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7
5

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o

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7
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8
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o

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P
e
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e
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t

w
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n

0
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5
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(
%
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7
9
8
6
.
2
8
4
.
5
7
6
.
9
6
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.
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2
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4
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e
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t

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n

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.
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(
%
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9
7
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9
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1
9
7
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3
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n

2
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0

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(
%
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1
0
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1
0
0
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0
0
1
0
0
9
6
.
7
N
/
A

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/
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N
/
A

P
o
s
t
-
o
p
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r
a
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y
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r








M
e
a
n

(
D
)
0
.
6
5

0
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4
3
0
.
4
3

0
.
2
8
0
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3
8

0
.
6
6
0
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5
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0
.
4
8
N
/
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/
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N
/
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0
.
9
6

0
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8
5
R
a
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e

(
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)
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.
7
5
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0
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3
.
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/
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0
.
0
0

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o

3
.
7
5
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a
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2
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6

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r

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r

(
%
)
4
.
8
1
0
.
3
6
.
9
4
.
8
N
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/
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N
/
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2
0
/
2
0

o
r

b
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r

(
%
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7
3
.
8
8
2
.
8
4
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6
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6
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N
/
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5
2
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4
0

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r

b
e
t
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r

(
%
)
9
7
.
6
1
0
0
9
6
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9
6
.
9
6
3
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2
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/
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8
0
P
o
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t
-
o
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e

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C
V
A



2
0
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1
6

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b
e
t
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r

(
%
)
1
1
.
8
1
3
.
8
1
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1
N
/
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/
A
N
/
A
N
/
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N
/
A
2
0
/
2
0

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r

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e
t
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r

(
%
)
8
5
.
3
8
6
6
7
.
2
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3
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1
6
0
.
1
5
.
3
5
.
5
2
2
0
/
4
0

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r

b
e
t
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r

(
%
)
1
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1
0
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/
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9
2
.
5
5
2
.
6
4
4
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4
6
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2
0
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1
6

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r

b
e
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t
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r

(
%
)
1
4
.
4
2
0
1
7
3
7
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6
N
/
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/
A
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/
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/
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2
0
/
2
0

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r

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t
t
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r

(
%
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9
4
9
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6
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2
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4
3
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5
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/
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1
9
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4
0

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r

b
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r

(
%
)
1
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/
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9
8
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1
9
4
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7
N
/
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9
3
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h
a
n
g
e

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n

B
S
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V
A








L
o
s
s

2

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r

m
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e

l
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s
0
0
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.
6
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7
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/
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5
.
6
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.
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1
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s
s

1

l
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(
%
)
8
.
8
6
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9
1
.
7
7
.
5
5
.
4
6
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2
N
/
A


N
/
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U
n
c
h
a
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d

(
%
)
2
6
.
5
4
8
.
3
3
6
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1
1
4
.
5
4
4
.
3
N
/
A


N
/
A


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/
A
G
a
i
n

1

l
i
n
e

(
%
)
4
7
.
1
3
4
.
5
4
3
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5
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5
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3
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N
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a
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n

2

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r

m
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l
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s

(
%
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6
4
0
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6
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/
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3
6
C
o
m
p
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c
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t
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n
s








V
i
s
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a
l
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y

i
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s
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g
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c
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t

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p
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(
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2
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7
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p
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(
%
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7
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l
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7

R
e
m
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v
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l

(
%
)
0
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.
6
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2
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3
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s
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(
%
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4
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0
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7

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8
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s

r
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(
%
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3
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0

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e
m
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l

w
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(
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a
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n
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(
%
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7
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1
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O
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t
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s







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9
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%

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w
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p
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*
*
3
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6
%

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w
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m
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p
ia








*
*
*

A
ll
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t
h
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d
e
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lo
p
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d

p
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h
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b
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fo
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IC
L
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M

im
p
la
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t
a
t
io
n
T
a
b
l
e

2
:

C
o
m
p
a
r
a
t
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v
e

s
t
u
d
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e
s

o
f

I
C
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a
n
d

T
o
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C
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f
o
r

m
y
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p
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a

a
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d

c
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n
d

m
y
o
p
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a
s
t
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g
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T
A
A
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S
u
r
g
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c
a
l
,

0
6
.
2
0
0
8
.

1
0
-
0
0
0
4
-
3
9
/
A
.





0
3
4
4
.

V
a
l
u
e
:

2
0
.
0
0

USERS
MANUAL
1
CHAPTER
ONE
2
CHAPTER
TWO
3
CHAPTER
THREE
4
CHAPTER
FOUR
5
CHAPTER
FIVE
6
CHAPTER
SIX
7
CHAPTER
SEVEN