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2019/11/21

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Soft Contact Lenses in Myopia Control

Helen Changmin Duan, OD, MS, FIAO

Assistant Clinical Professor, Emeritus,

SUNY College of Optometry

Board of Directors Member IAOMC, Asia

MYOPIA in CHILDREN NON-SURGICAL TREATMENTLodz, Poland November 23, 2019

• Consultant for Paragon Vision Sciences

Financial Disclosure

Time: September 30, 2016 from 8 a.m. – 6 p.m. Location: FDA White Oak Campus in Silver Spring, MD.

Purpose:

This workshop will greatly inform the premarket evaluation of contact lenses and other devices designed to control myopia progression.

Most Often Prescribed Myopia Control Methods Contact Lens Spectrum, Volume: 30 , Issue: January 2015, page(s): 34, 36, 38-40

• CLCS of AOA presented “Controversies in Contact Lens Care” at the 2014 Optometry’s Meeting in Philadelphia.

Standard Soft Lenses and Myopia ProgressionWalline et al. Invest Ophthalmol Vis Sci 2008;49:4702-6

Mean ± SD unadjusted cycloplegic spherical equivalent refractive error in soft contact lens wearers and spectacle wearers.

Mean ± SD unadjusted axial length in soft contact lens wearers and spectacle wearers.

“Soft contact lens wear by children does not cause a clinically relevant increase in axial length, corneal curvature, or myopia in relation to spectacle lens wear.”

GP in Myopia Control Walline JJ, Jones LA, Mutti DO, Zadnik K. A randomized trial of the effects of rigid contact lenses on myopia progression. Arch Ophthalmol 2004;122:1760–6.

RGP vs. Soft Lens for 3 years

• Myopia progression: less in

RGP group

• Cornea Curvature: flatter in

RGP group

• Axial Length: no difference

Spherical Equivalent

CorneaCurvature

Axial Length

1 2

3 4

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Effect of Dual-Focus Soft Contact Lens Wear on Axial Myopia Progression in Children Anstice and Phillips Ophthalmology 2011;118:1152-61

• 11-14 years old (-1.25 to -4.50 D SER)• Dual-focus lens; concentric zones (+2.00 D)• Worn in one eye for 10 months then switched to

other for next 10 months (other eye wore control SCL)• After the first 10 months:

0.25 D reduction in SER change0.11 mm reduction in axial elongation

• After the second 10 months (cross-over)Asymmetry between eyes reversed

• Designed for children’s

large pupils

• Correction zones (C),

correct the refractive

error

• Treatment zones (T)

provide 2.00 D

• Simultaneous myopic

retinal defocus



Children wore a DF lens in one randomly assigned eye and an SVD lens in the other eye for 10 months (period 1). Lens assignment was then swapped between eyes, and lenses were worn for a further 10 months (period 2).

Multifocal Contact Lens Myopia Control Walline, J. et. al.; Optometry & Vision Science. 90(11):1207-1214, November 2013

• 8-11 year old children (-0.75 D to -4.00 D)

• Control group: Historical SCL wearers

• Proclear Multifocal “D” lens; +2.00 D add

• 2-year results• 0.52 D treatment effect (50% effect)• 0.12 mm reduction in axial growth (29%

effect)

FIGURE 2. Mean ± standard deviation unadjusted axial length of multifocal and single-vision contact lens wearers.

Proclear Multifocal, Cooper Vision center D in both eyes. +2.00D add.

Multifocal Contact Lens Myopia Control Walline, J. et. al.; Optometry & Vision Science. 90(11):1207-1214, November 2013

Defocus Incorporated Soft Contact – DISC Lens Lam et al Br J Ophthalmol 2014;98:40-5

DISC lens:

• Custom-made bifocal soft contact lens

correction zone in a series of alternating

defocusing and correction

• Zones extending towards the periphery having

a proportion of 50:50

• Defocusing zones were +2.5 D relatively

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9 10

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SEM: spherical equivalent refractions

2-year clinical trial

80 children between 8-13 yo.

Progression halved each year

compared to SV lens wearers

Defocus Incorporated Soft Contact lens (DISC)Carly Siu Yin Lam et al. Br J Ophthalmol 2014;98:40-45 BSCL Prospective Twin Study

Aller & Wildsoet, Clin Exp Opt, 2008

• 2-year case control study

• Subjects: 12-year old identical twin girls

• Initial Rx: Twin A -1.56 D; Twin B -1.43 D

• Each twin has esophoria at near

• Double-masked design: randomly assigned to Acuvue 2 SCLs or Acuvue

Bifocal

• Cycloplegic and manifest subjective and objective refractions

• Axial lengths by IOL Master second year

BSCL Prospective Twin StudyAller & Wildsoet, Clin Exp Opt, 2008

• SVL: Acuvue 2,

• BFL: Acuvue Bifocal

Peripheral Gradient Soft LensPaune, J et. al. BioMed Research International Volume 2015

SRRG: -0.56 +/-0.51SV：-0.98 +/-0.58OK：-0.32 +/-0.53

Authors Study (mont

hs)# of Subject Treatment Contat

Lens DesignsExperiment

Design

Age Ethnicit

y

Criteria of Rx

Myopia Progressio

n %/yr

Myopia Progressio

n D/yr

Anstice and Phillips (2011) 10

SV CL, n=40 Dual-Focus Randomized, paired-eye

control, cross-over

11–14, diverse

ethnicity

−1.25 to −4.5

1st period: 0.25 (37%)

1st period: 0.3

DF (2 D ), n=40 distance center, multifocal +2.00 add

2nd period: 0.2 (54%)

2nd period: 0.24

Sankaridurg et al(2011) 12

SVL, n=40 novel lens

Randomised 7–14, Chinese

−0.75 to −3.5 0.29 (34%) 0.29

novel CL, n=45

distance center, progressive to +1.00 D

at 2mm, +2.00 at 4.5mm

Walline, J et al. (2013) 24 SV CL n=32 SMFCL

n=32

Proclear Multifocal, distance center +2.00D

add

Historical control group

8- 11, White

-1.00 to -6.00 0.52 (50%) 0.26

Lam, C, et al. (2014) 24

SV CL, n=47 DISCRandomized,

masked8–13,

Chinese−1 to −5. 0.21 (25%) 0.11

DISC, n=49 custom-made, multi-zones, +2.5 D

Jaime Paune, el al (2015) 24

SRRG CL, n=19 SRRG: Distance center, plus add gradual to +2.00D at 35 degree and +6.00D at 4mm edge of optical zone

1 test and 2 control

groups, not randamized

9–16, White

−0.75 to

−7.000.42 (43%) 0.21OK, n= 18

SV, n=21

13 14

15 16

17 18

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Authors Study (mont



Design

Age Ethnicit

y

Criteria of Rx

Myopia Progressio

n %/yr

Myopia Progressio

n D/yr



control, cross-over

11–14, diverse

ethnicity

−1.25 to −4.5

1st period: 0.25 (37%)

1st period: 0.3


2nd period: 0.2 (54%)

2nd period: 0.24




−0.75 to −3.5 0.29 (34%) 0.29

novel CL, n=45


at 2mm, +2.00 at 4.5mm


n=32


add


8- 11, White

-1.00 to -6.00 0.52 (50%) 0.26

Lam, C, et al. (2014) 24


masked8–13,

Chinese−1 to −5. 0.21 (25%) 0.11






9–16, White

−0.75 to

−7.000.42 (43%) 0.21OK, n= 18

SV, n=21

Authors Study (mont



Design

Age Ethnicit

y

Criteria of Rx

Myopia Progressio

n %/yr

Myopia Progressio

n D/yr



control, cross-over

11–14, diverse

ethnicity

−1.25 to −4.5

1st period: 0.25 (37%)

1st period: 0.3


2nd period: 0.2 (54%)

2nd period: 0.24




−0.75 to −3.5 0.29 (34%) 0.29

novel CL, n=45


at 2mm, +2.00 at 4.5mm


n=32


add


8- 11, White

-1.00 to -6.00 0.52 (50%) 0.26

Lam, C, et al. (2014) 24


masked8–13,

Chinese−1 to −5. 0.21 (25%) 0.11






9–16, White

−0.75 to

−7.000.42 (43%) 0.21OK, n= 18

SV, n=21

Authors Study (mont



Design

Age Ethnicit

y

Criteria of Rx

Myopia Progressio

n %/yr

Myopia Progressio

n D/yr



control, cross-over

11–14, diverse

ethnicity

−1.25 to −4.5

1st period: 0.25 (37%)

1st period: 0.3


2nd period: 0.2 (54%)

2nd period: 0.24




−0.75 to −3.5 0.29 (34%) 0.29

novel CL, n=45


at 2mm, +2.00 at 4.5mm


n=32


add


8- 11, White

-1.00 to -6.00 0.52 (50%) 0.26

Lam, C, et al. (2014) 24

SV CL, n=47 DISC Randomized, masked

8–13, Chinese

−1 to −5. 0.21 (25%) 0.11






9–16, White

−0.75 to

−7.000.42 (43%) 0.21OK, n= 18

SV, n=21

Authors Study (mont



Design

Age Ethnicit

y

Criteria of Rx

Myopia Progressio

n %/yr

Myopia Progressio

n D/yr



control, cross-over

11–14, diverse

ethnicity

−1.25 to −4.5

1st period: 0.25 (37%)

1st period: 0.3


2nd period: 0.2 (54%)

2nd period: 0.24




−0.75 to −3.5 0.29 (34%) 0.29

novel CL, n=45


at 2mm, +2.00 at 4.5mm


n=32


add


8- 11, White

-1.00 to -6.00 0.52 (50%) 0.26

Lam, C, et al. (2014) 24

SV CL, n=47 DISC Randomized, masked

8–13, Chinese

−1 to −5. 0.21 (25%) 0.11






9–16, White

−0.75 to

−7.000.42 (43%) 0.21OK, n= 18

SV, n=21

MiSight® 1-day contact lenses

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Bifocal Lenses In Nearsighted Kids (BLINK) Walline et.al: A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods, Optom Vis Sci 20194:857; 6–866.



Theory of Myopia

• Accommodation

• Classic theory - over hundreds of years

• Lag of accommodation exists at the onset of myopia (pre or post)

• Esophoric group shown better myopia control effect with +2.00D

add spectacles or bifocal contact lenses

• Peripheral Hyperopic Defocus

• Slowing down myopia progress using bifocal/multifocal contact lens and orthokeratology in animal models and clinical studies

Accommodation in Wearing Bifocal Soft Contact Lenses Tarrant, J, et. al: Accommodation in emmetropic and myopic young adults wearing bifocal soft contact lenses

Over accommodation of myopes when wearing the BF contact lenses may explain the reported efficacy as myopia control treatment

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Summary

• Group of wearing single vision soft contact lens demonstrated the

similar myopia progression as that of wearing spectacles

• Clinical studies proved bifocal and multifocal soft contact lens slow

down the progress of myopia

• Based on the design of concentric rings, the treatment zone design

varies from add of +1.0D to +6.50D

• Reducing the demand of accommodation when wearing bifocal or

multifocal lenses may play a role in their mechanism

THANKS联系方式：

[email protected]

or

[email protected]

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9ULZ )UTZGIZ 2KTYKY OT 3 UVOG )UTZXUR · 9ulz iutzgiz rkty ]kgx h_ inorjxkt juky tuz ig[yk g irotoigrr_ xkrk\gtz otixkgyk ot g^ogr rktmzn iuxtkgr i[x\gz[xk ux s_uvog ot xkrgzout zu