University of Hyderabad (A Central University Established in 1947 by An Act of Parliament) Hyderabad - 500046

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University of Hyderabad

(A Central University Established in 1947


by an Act of Parliament)
Hyderabad – 500046

Title
A Comparative Review Of Different Multifocal Soft
Contact Lenses For Myopia Control

Student
Waqar Khan
Supervisor
Dr. Nagaraju Konda

Academic Year: 2021


1
Submitted in support of the Degree of Integrated
Masters of Science in Optometry & Vision Science

2
A Comparative Review of Different Multifocal Soft
Contact Lenses for Myopia Control
by

Waqar Khan

Dissertation Submitted to the


University of Hyderabad, Hyderabad, India
In partial fulfillment
of the requirements for the degree of

Integrated Masters in Optometry & Vision Science

Under the guidance of


Dr. Nagaraju Konda

Year: 2021

3
DECLARATION BY THE CANDIDATE

I hereby declare that this dissertation entitled “A Comparative Review of Different

Multifocal Soft Contact Lenses for Myopia Control" is a bonafide and genuine

research work carried out by me under the guidance of Dr.Nagaraju Konda,

Assistant Professor, School of Medical Sciences.

Date: 10/07/2021 Signature of the Candidate


Place: University of Waqar Khan
Hyderabad

4
CERTIFICATE BY THE GUIDE

This is to certify that the dissertation entitled ''A Comparative Review of

Different Multifocal Soft Contact Lenses for Myopia Control" is a

bonafide research work done by Waqar Khan in partial fulfillment of the

requirement for the degree of Integrated Masters in Optometry & Vision Science.

Date: 10/07/2021 Signature of the Guide


Place: University of Dr. Nagaraju Konda
Hyderabad Assistant Professor,
School of Medical Sciences

5
ENDORSEMENT BY THE COURSE COORDINATOR AND DEAN OF
THE SCHOOL

This is to certify that the dissertation entitled “A Comparative Review of

Different Multifocal Soft Contact Lenses for Myopia Control" is a

bonafide research work done by Waqar Khan under the guidance of Dr. Nagaraju

Konda, Assistant Professor, School of Medical Sciences.

Date: 10/07/2021 Signature of the Course


Place: University of Coordinator
Hyderabad Dr. Nagaraju Konda

Date: 10/07/2021 Signature of the Dean


Place: University of Name
Hyderabad

6
COPYRIGHT

Declaration by the Candidate

I hereby declare that the School of Medical Sciences, University of Hyderabad,

Hyderabad shall have the rights to preserve, use and disseminate this

dissertation/thesis in print for academic / research purposes.

Date: 10/07/2021 Signature of the Candidate


Place: University of Waqar Khan
Hyderabad

7
ACKNOWLEDGMENT

I wish to thank my guide, Dr. Nagaraju Konda, for supervising me and being
patient with me through this project. I also want to thank my parents for always
supporting me and my classmates and friends for regularly providing me with
their valuable inputs, without which this work would not have come to fruition.

Date: 10/07/2021 Signature of the Candidate


Place: University of Waqar Khan
Hyderabad

8
LIST OF ABBREVIATIONS USED

MFSCL- multifocal soft contact lens


SV CL- single vision contact lens
PAL- progressive addition lens
MD- myopic defocus
SER- spherical equivalent refraction
SECAR- spherical equivalent cycloplegic autorefraction
OK- orthokeratology
DF- dual focus
DISC- defocus- incorporated soft contact
SRRG- soft radial refractive gradient
+SA- positive spherical aberration

9
ABSTRACT

Background & Objectives

Previous studies on myopia control have established the efficacy of multifocal soft

contact lenses in controlling the progress of myopia, on par with traditional methods

like orthokeratology (OK) and Atropine/pirenzepine administration. New lens designs

have emerged over the past few years, which have prevented myopia with varying

degrees of success in various clinical trials. We compare and analyze these lens

designs in this review to determine which MFSCL design has the best efficacy against

progressive myopia. The MFSCLs included in this review are: dual focus(DF) lenses,

defocus-incorporated soft contact (DISC) lenses, soft radial refractive gradient lenses

(SRRG), positive spherical aberration (+SA) lenses, and MiSight 1 day lenses.

Methods

Review of relevant articles published in the period from January 2000 till June 2021

was done. Twelve articles were found that met the criteria.

Interpretation & Conclusion

MiSight 1 day® lenses provide the most optimum treatment for myopia progression

out of all the reviewed MFSCL designs. Soft lenses incorporating refractive gradient

design(SRRG) have also shown promising results, though more clinical trials with

proper randomization need to be conducted to confirm its efficacy. Further research

10
needs to be made on lens efficacy and the status of myopia after the end of the trial

period

Keywords

('myopia', 'myopia control', 'multifocal contact lenses', 'soft contact


lenses', 'myopia progression', dual focus' and 'refractive gradient' )

11
TABLE OF CONTENTS

1. Introduction 14

2. Objectives 16

3. Methodology 17

4. Discussion 22

5. Conclusion 28

6. Bibliography 29

12
LIST OF TABLES

Sl.No Tables Pages

1 Clinical studies on myopia control using MFSCLs 25

Comparison of MFSCL studies' dropout rate


2 and post-trial status 27

13
1. Introduction

Myopia is defined as a condition in which the spherical equivalent objective refractive

error is ≤ –0.50 diopter (–0.50 D) in either eye[1]. The prevalence of myopia has

increased rapidly over the past few decades, reaching epidemic proportions in certain

Asian countries[2]. Twenty-eight percent of the global population was said to be affected

in 2010 and to rise to affect nearly 50 percent by 2050[3]. High myopia is defined as a

condition in which the spherical equivalent objective refractive error is ≤ –5.00 D in

either eye[1], and it also contributes to sight-threatening pathologies such as cataracts

glaucoma, and especially myopic maculopathy[4]. Traditional methods of controlling

myopia include under-correction of minus power and, in the later years, dispensing

progressive addition lenses(PALs). However, while several studies have found the under-

correction technique to be not only ineffective in treating myopia but myopigenic

instead[5][6], PALs have been shown to be insignificant for long-term usage[7].

Atropine(0.05%) dosage has shown promising results in controlling myopia

progression[8], with low dose atropine being associated with lesser adverse effects

compared to higher or moderate doses[9]. In recent years, orthokeratology(OK) has been

established as one of the best methods for myopia control in children by several

studies[10][11]. Overnight OK wear has shown a more rapid effect compared to

traditional OK wear, with most change occurring after the first night of lens wear and

stability of refractive change after seven to 10 days. Mean reductions in myopic

refractive error of between 1.75 and 3.33 D and individual reductions of up to 5.00 D

have been reported, while most patients achieve 6/6 unaided vision or better[12]. In the

past few years, multifocal soft contact lenses (MFSCLs) have emerged as a leading

14
choice of treatment for controlling myopia progression. Novel lens designs have been

introduced and studied to test their efficacy compared to traditionally used techniques

like orthokeratology and Atropine administration[13]. In this review, we will look at

these various MFSCL designs and compare their performance to conclude which design

provides the best treatment option for myopia.

15
2. Objectives

This article aims to analyze these novel multifocal lens designs that include: Dual

Focus (DF) lenses, Defocus- Incorporated Soft Contact (DISC) lenses, Soft Radial

Refractive Gradient (SRRG) lenses, positive spherical aberration (+SA) lenses, and

MiSight contact lenses, and compare their efficacy with respect to parameters like

change in the spherical equivalent refraction (SER), axial length changes and duration

of effect to infer which lens design amongst these candidates provide the best

treatment option for myopia.

16
3. Methodology

Study design

Literature review

Relevant literature regarding multifocal soft contact lenses and myopia control

published in reputed journals was systematically searched and selected with the help

of search engines like Google Scholar, National Library of Medicine (Medline)

database, and reference lists mentioned in the searched articles. Keywords that

include: 'myopia', 'myopia control', 'multifocal contact lenses', 'soft contact lenses,

'efficacy', 'axial length', 'positive spherical aberration', 'myopia progression', 'defocus',

'myopic defocus', dual focus' and 'refractive gradient' were used to filter and optimize

our search results. The methodological quality of the included trials and research were

assessed using tools such as Jadad Scale[14] and the critical appraisal skills

programme (CASP) checklist. The selected literature was cataloged and organized

using the Mendeley App.

Inclusion Criteria

Articles published between January 2000 and June 2021 were included. Articles that

addressed myopia control, multifocal contact lenses, and myopic defocus were

included. Articles published in peer-reviewed journals were included in this review.

The original articles regarding the study were only considered.


17
Exclusion criteria

Articles that did not meet the inclusion criteria were not included. Articles without

full text, author bias, or ones published in languages other than English were

excluded.

Contact Lens Designs

The DF soft contact lenses[15] comprise a central correction zone surrounded by a

series of treatment and correction zones that together produced two focal planes. The

optical power of the correction zones corrects the refractive error while the treatment

zones produce 2.00 D of simultaneous myopic retinal defocus. The central correction

zone is made as large as possible to stimulate accommodation and to provide good

acuity, and the zone diameters are selected so that some treatment area remains within

the confines of the pupil during near viewing. Contact lenses were lathe cut in

Hioxifilcon A (Benz Research and Development, Sarasota, FL), a non-ionic 45%

water-content material with an 8.5-mm base curve and 14.2-mm total diameter.

DISC lens[16] is a custom-made bifocal soft contact lens of concentric rings design. It

comprises a correction zone in the center and a series of alternating defocusing and

correction zones extending towards the periphery having a proportion of 50:50. The

correcting zones match the distant prescription, while the defocusing zones were 2.5

18
D relatively negative. Such design allows introducing myopic retinal defocus and

maintaining clear vision simultaneously. The lenses are lathe-cut from 2-hydroxyethyl

methacrylate, with 38% water content, base curve between 8.0–8.9 mm and a lens

diameter of 13.5 mm or 14.0 mm.

Design of the DF contact lens. A, Correction zone (outer) diameters were C1=3.36 mm, C2=6.75 mm,
and C3=11.66 mm. Treatment zone (outer) diameters were T1=4.78 mm and T2=8.31 mm. B, During
distance viewing, the focal plane F(C) of the correction zones fell on the retina and the focal plane of
the treatment zones F(T) fell anterior to the retina, thus causing myopic defocus on the retina. C, With
accommodation during near viewing, the focal plane F(C) of the correction zones was still located on
(or near) the retina and the focal plane of the treatment zones F(T) remained anterior to the retina,
causing myopic defocus on the retina. DF=Dual-Focus. (Figure from N. Anstice, J. Phillips: Effect of
Dual-Focus Soft Contact Lens Wear on Axial Myopia Progression in Children, Ophthalmology Volume
118, Number 6, June 2011)[15]

A previous study has proved the concentric ring bifocal design of contact lens to be

clinically effective for controlling myopia in school-aged children, with an overall

myopia control rate of 30~50% over 2 years[17].


19
The experimental SRRG lens[18] is designed to produce peripheral myopic defocus.

The contact lens is made of 2-hydroxy-ethyl methacrylate, a non-ionic material, with

38% water content and 12 Barr of oxygen permeability (Dk) (Servilens, Granada,

Spain). The central thickness varied with optical power ranging from 0.09 to 0.14

mm. The overall diameter is 14.00 to 15.00mm. The base curve radius ranged from

8.00 to 8.90mm and was calculated to be 0.7mm flatter than the average keratometric

radius. Experimental soft lenses have unique central back and front optical zones of

8mm in diameter, and only the central apical zone has the power required for distance

vision. The progressive design provides an increasing add power that reaches +2.00D

add plus power, which corresponds to about 35 degrees of retinal eccentricity and

achieves about +6.00D of addition plus power at the edge of the optical zone (4mm

semi chord diameter).

The +SA contact lenses[19] are soft lenses designed with aspheric front surfaces

incorporating +SA. The materials used are etafilcon A with LACREON technology,

diameter (14.0 mm), and base curve (8.5 mm). The level of +SA introduced to the

lens’ optical zone was about 0.175 micron (for a 5-mm-diameter aperture) across all

lens powers, which was chosen to negate the negative SA that occurred in myopic

subjects during accommodation.

MiSight 1 day (CooperVision)[20][21] is a daily replacement hydrophilic soft CL

composed of Omafilcon A material that must be discarded after each removal.

MiSight CLs contain a large central correction area of 3.36 mm surrounded by

concentric zones of alternating distance and near powers, which together produce two

focal planes[8]. The optical power of the correction zones corrects the refractive error

20
while the treatment zones produce 2.00 D of simultaneous myopic retinal defocus

during both distance and near viewing. The dimension of the central correction area

has been designed to provide good distance visual acuity and the near power is

intended as a treatment zone to prevent myopic progression, imposing myopic

defocus on the more peripheral retina as a stimulus to slow eye growth.

21
4. Discussion

Dual Focus(DF) Lenses:

Out of all the contact lens designs analyzed in the selected studies for the same

duration of the study, Dual Focus SCLs used by Anstice and Phillips (2011)[15]

proved to have the maximum impact in controlling myopia progression at the end of

their 20-month period trial. Change in SER was found to be 54% lesser than the

control group while the change in axial elongation was 80% lesser.

However, the study was conducted in two phases: period 1 which had a duration of 10

months and period 2 having a duration of another 10 months in which the DF contact

lens was switched with the control single vision contact lens of the contralateral eye.

This might have resulted in uncertainties associated with the interpretation of data

after cross-over at the end of period 1 which has been acknowledged by the authors as

well. This uncertainty prevents us from declaring DF SCLs as the outright best choice

of treatment for myopia control amongst all the other candidates in this review.

Positive Spherical Aberration(+SA) Lenses:

+SA contact lenses[19] had a statistically significant impact on axial elongation. Eyes

wearing test lenses increased in length by 0.11 (65.3%) and 0.14 (38.6%) mm less

than eyes wearing control soft lenses at 6 and 12 months, respectively. The principal

control of axial elongation occurred during the first 6 months.

22
The soft contact lens with +SA slowed axial growth of the eye, although this did not

translate into a sustained statistically significant effect on SER, which decreased as

the duration of the study progressed (20% change at the end of 1 year from 54% at the

end of 6 months).

The majority of the treatment effect occurred in the initial 6 months of wear. After

ceasing treatment, neither the rate of axial elongation nor change in spherical

equivalent cycloplegic autorefraction (SECAR) was significantly different between

the initial two cohorts.

Also, in a follow-up study done by Cheng et al. [22] on the same subject pool,

checking the accommodative response changes in eyes with +SA lenses compared to

the control group, it was found that the soft contact lens with +SA for controlling

myopia progression resulted in an apparent decrease in mean accommodation. It was

found that some subjects in the test pool used +SA for near viewing, inducing a

hyperopic defocus at the retina and hence, increasing the rate of myopia progression.

Soft Radial Refractive Gradient(SRRG) Lenses:

The SRRG lenses[18] had the most impactful effect on the change in SER after a 2-

year period out of all the other MFSCL candidates (excluding DF lenses at the end of

period 2 trial). SRRG lenses slowed the progress of the refractive error by 43% and

lessened axial elongation by 27% at the end of the 2-year duration.

23
However, the study involving SRRGs is conducted using a non-randomised design

that might increase the risk of investigator-subject bias that we should take into

account during our assessment of the quality of the study and its results.

Defocus - Incorporated Soft Contact(DISC) Lenses:

DISC lenses[16] performed decently in controlling myopia in its two-year trial. DISC

lenses slowed the progress of refractive error by 25% and lessened axial elongation by

31%.

MiSight Lenses:

MiSight soft lenses[21] by CooperVision had the most effective overall impact out of

all the selected candidates for this review (excluding DF lenses at the end of period 2

trial). Both SER and axial elongation changes were considerably reduced at the end of

the 2-year trial, with the progress in refractive error reduced by 39.32% and the

decrease in axial length elongation by 36.04%. Another study, a 3-year randomized

controlled trial conducted by Chamberlain et al. [23] at four investigational sites

(Portugal, UK, Singapore and Canada), further proved the safety and efficacy of

MiSight lenses. Further follow-up trials for 4- and 5-year periods[24][25] conducted

with MiSight lenses also show promising results in addition to better patient

compliance.

24
Table 1: - Clinical studies on myopia control using MFSCLs

Lens Author Period Design Age(yea Criteria Interv %decrease in


Type (s) (months) rs), of Rx ention myopia
ethnicity (D) and
sample
spherical axial
size(n)
equivalent length

Dual
Focus(
Anstice 10
& (period
Rando 11-14,
mised, diverse

1.25
SV CL, 36
n=40
50

DF) Phillips 1) paired- ethnicity to −4.5 DF (2


(2011)15 eye D
control, MD),
cross- n=40
over

DISC
lenses
Lam C, 24
et al.
Rando
mised,
8-13,
Chinese
−1 to
SV CL, 25
n=47
31
−5
(2014)16 masked DISC,
n=49

25
SRRG Pauné 24 Non- 9-16, −0.75 to SRRG, 43 27
lenses et al. random Caucasia −7.00 n=30
(2015)18 ised, n OK,
unmask n=29
ed SV CL,
n=41

+SA Cheng 12 Rando 8-11, -0.75 to +SA 20 38.6


lenses et al. mised, 90%- -4.00 CL,
(2016)19 double Chinese; n=64
masked 10%- SV CL,
others n=63

MiSight Pomeda 24 Rando 8-12, 86- −0.75 MiSigh 39.32 36.04


lenses et al. mised, 88% to −4.00 t CL,
(2018)21 masked Caucasia n=46
n SV CL,
n=33

DF= dual focus, DISC= Defocus-incorporated soft contact, SRRG= soft radial refractive gradient, +SA= positive
spherical aberration, SV CL= single vision contact lenses, OK= orthokeratology, MD= myopic defocus

26
Table 2: - Comparison of MFSCL studies' dropout rate and post trial
status

Lens Type Author(s) Subject dropout rate Myopia status post


(in %) trial

Dual Focus(DF) Anstice & Phillips 10 Not reported


(2011)15

DISC lenses Lam C, et al. 42 Not reported


(2014)16

SRRG lenses Pauné et al. 42 Not reported


(2015)18

+SA lenses Cheng et al. 17 No significant


(2016)19 difference between
control and test
cohorts

MiSight lenses Pomeda et al. 6.3 Not reported


(2018)21

27
28
5. Conclusion

Multifocal contact lenses slow the progression of myopia and are one of the most

effective methods to control myopia to date. Out of all the multifocal soft contact lens

designs selected for this review, MiSight by CooperVision provided the most

optimum results in reducing myopia progression and axial length elongation. SRRG

lenses have also proved to be a viable alternative and have had the best results in

lowering refractive error progression out of the other candidates. Changes in the

accommodative response in eyes fitted with +SA lenses indicate that the potential

impact of lens optics on accommodative function should be considered during the

design of myopia control lenses[22].

Limitations and gaps in knowledge:

Further research needs to be carried out to check the efficacy of DF contact lenses

after a continuous wear period of at least 20-24 months on a single tested eye. More

clinical trials with proper randomization and masking need to be conducted on SRRG

lenses to confirm its efficacy. Very few of the included studies have reported the

effects of the MFSCLs after the cessation of the trial period and the time it took for

myopia to set in during follow-up trials.

29
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