Evidence-based myopia management, what …idaho.aoa.org/Documents/ID/CongressOD2016/myopiaidaho-handout.pdf · Evidence-based myopia management, what ... OVS 2004; 81(6): 407–413

Presented by Dr. Raymond Chu at

Idaho Optometric Physicians Annual Congress 2016

Evidence-based myopia

management, what

works and what doesn’t

DISCLOSURE STATEMENT

I certify:

I have no proprietary interest in the tested

product

I have no equity interest or significant

payments by the sponsor of a covered study

Lecture content and format is free from

commercial bias

Lecture content was independently prepared

by myself

Arch Ophthalmol.

2009;127(12):1632-1639 2523 children in grades 1 to 8 (age 5-17 years)

White (n=1035)

African American (n=534)

Asian (n=491)

Hispanic (n=463)

Overall

Myopia (≥ 0.75 D)

4.4% 6.6% 18.5% 13.2% 9.2%

Hyperopia (≥ 1.25 D)

19.3% 6.4% 6.3% 12.7% 12.8%

Astigmatism (≥ 1.00D)

26.4% 20.0% 33.6% 36.9% 28.4%

Arch Ophthalmol. 2003; 121(8):1141-7.

Atropine in the Treatment

of Myopia Study (ATOM)

RATIONALE

Animal studies

myopia retardation is

independent of

accommodative effect

STUDY DESIGN

Randomized, placebo-controlled trial

400 children 6-12 years

-1.00 to -6.00D

1% atropine / placebo drops to 1 eye

1° outcome: Cycloplegic autorefraction

Opthalmol 2006;113(12): 2285-2291



RESULTS

1 year (n=359)

Placebo eyes = -0.76 D ± 0.44 D

Atropine eyes = +0.30 D ± 0.50 D

2 years (n=346)

Placebo eyes = -1.20 D ± 0.69 D

Atropine eyes = -0.25 D ± 0.92 D

Opthalmol 2006;113(12): 2285-2291 Opthalmol 2006;113(12): 2285-2291

1 year after cessation

1.14 ± 0.80

0.38 ± 0.39 D

1 year after cessation

Atropine

treated eye

Atropine

untreated eye

Initial amps 13.76 ± 3.45 13.86 ± 3.58

3 yr amps 14.64 ± 2.56 15.22 ± 2.63

Initial near

VA

0.50 ± 0.11 0.50 ± 0.11

3 yr near VA 0.38 ± 0.06 0.38 ± 0.06

ATOM 2

Three concentrations of atropine eye drops to

be applied once nightly in both eyes:

0.5% atropine (n=161)



Ophthalmology 2012;119:347–354



0.01%: -0.43 (0.52)

0.1%: -0.31 (0.50)

0.5%: -0.17 (0.47)

0.01%: -0.49 (0.63)

0.1%: -0.38 (0.60)

0.5%: -0.30 (0.60)

Atropine

0.01%

Atropine

0.1%

Atropine

0.5%

P value

Spherical Equivalent

∆ over 1

yr

-0.43

(0.52)

-0.31

(0.50)

-0.17

(0.47)

<0.001

∆ over 2

yrs

-0.49

(0.63)

-0.38

(0.60)

-0.30

(0.60)

0.07

Axial Length

∆ over 1

yr

0.24 (0.19) 0.13 (0.18) 0.11 (0.17) <0.001

∆ over 2

yrs

0.41 (0.32) 0.28 (0.27) 0.27 (0.25) 0.002

Atropine

0.01%

Atropine

0.1%

Atropine

0.5%

P value

Mesopic pupil size (mm)

∆ over 1

yr

1.15 (0.78) 2.77 (1.03) 3.50 (1.05) <0.001

∆ over 2

yrs

1.15 (0.71) 2.71 (1.12) 3.56 (1.14) <0.001

Near vision (logMAR)

∆ over 1

yr

-0.01

(0.10)

0.10 (0.16) 0.32 (0.19) <0.001

∆ over 2

yrs

-0.02

(0.08)

0.06 (0.13) 0.25 (0.19) <0.001

Am J Ophthalmol 2014;157:451–457

Ophthalmology 2016; 123:391-399 Near

Viewing

Accommodative Lag Axial Elongation

Blur is a critical component

in development of myopia

IOVS 1993; 34(3): 690-694



Near

Viewing

BIFOCAL

STUDY DESIGN

Randomized clinical trial

SV versus Bifocals (FT +1.50)

for 30 months

At least -0.50 D

A Trial of Bifocals in Myopic

Children With Esophoria

OVS 2000; 77(8): 395–401 Correction of Myopia

Evaluation Trial (COMET)

STUDY DESIGN

Multi-center, randomized, double-masked

To evaluate whether PAL's (Varilux

Comfort™, +2.00 add) vs single vision lenses

(SVL)

SEQ: -1.25 to -4.50

469 children (6 - 11 y.o.)

PAL

(n = 235)

SVL

(n = 234) Difference

Mean Myopic

Progression -1.28 ± 0.06 -1.48 ± 0.06 0.20 ± 0.08

IOVS 2003; 44(4): 1492-1500

PAL

SVL

-1.4

-1.2

-1.0

-0.8

-0.6

-0.4

-0.2

0.0

Δ F

rom

BL

in

SE

Cy

clo

Au

to (

D)

1 Yr 2 Yr 3 Yr BL

3-Year Change in Cycloplegic Autorefraction

IOVS 2003; 44(4): 1492-1500



PAL SVL Difference

≥0.43D Lag

& Eso -1.08 (n=42) -1.72 (n=34) 0.64

≥0.43D Lag

& ≤-2.25D -1.11 (n=44) -1.59 (n=60) 0.48

≥0.43D Lag

& <31.2 cm -1.24 (n=64) -1.68 (n=52) 0.44

IOVS 2003; 44(4): 1492-1500 COMET 2

To evaluate whether PAL's (Varilux

Comfort™, +2.00 addition) slow the rate of

myopic progression in children with near-point

eso, a lag of accommodation, and low amounts

of myopia vs single vision lenses (SVL)

IOVS. 2011 Apr 25;52(5):2749-5

-0.29

-0.58

-0.87 -0.42

-0.80

-1.15

Contact Lens and Myopia

Progression Study (CLAMP)

Rationale

Previous studies have suggested that RGP’s

may slow the progression of myopia in

children

STUDY DESIGN

Run-in period before randomization

RGP’s versus soft contact lenses

Children 8-11 yrs

-0.75 to -4.00 SEQ

No previous CL wear

Arch Ophthalmol 2004;

122(12):1760-66


122(12):1760-66

0.81




122(12):1760-66


122(12):1760-66

Conclusions

RGP lenses are a viable choice for refractive

correction in patients 8 to 11 years of age

(CLAMP: 78.6% of subjects)

A portion of the treatment effect is likely to be

temporary and due to corneal flattening

Children’s Overnight

Orthokeratology Investigation

GOAL

To examine the safety and effectiveness orthokeratology lens in children

STUDY DESIGN

A prospective case series

Children 8-11 yrs

-0.75 to -5.00 SEQ

No RGP use

OVS 2004; 81(6): 407–413

OVS 2004; 81(6): 407–413

Visit High Contrast

(Mean ±SD)

Baseline 0.67 ± 0.22 (20/94)

1 Day 0.50 ± 0.22 (20/63)

1 Week 0.28 ± 0.21 (20/38)

2 Weeks 0.16 ± 0.21 (20/29)

1 Month 0.14 ± 0.15 (20/28)

3 Months 0.14 ± 0.22 (20/28)

6 Months 0.08 ± 0.15 (20/24)

OVS 2004; 81(6): 407–413

CONCLUSION

Mean reduction: -2.48 ± 1.57 D (98%)

~2 weeks of wear, subjects were able to see

clearly throughout the entire day

~1 month of wear, some were able to wear

every other night

~3/5 of the subjects had corneal staining



CRAYON Pilot Study

8 to 11 years old

Between -0.75 D and -4.00 D

Primary outcome: difference in the 2-year

change in axial length

Compared to a control group randomized to

soft CL

Br J Ophthalmol 2009; 93:1181–1185.

Eye growth

is slowed

by 55%

STUDY DESIGN

Prospective Case-Controlled Trial

35 children 7-12 years

SEQ: -0.25 to -4.50D (< 2.00 DC)

1° outcome: Axial Length

Longitudinal Orthokeratology

Research in Children (LORIC) Curr Eye Res 2005; 30(1):71–80

Control Ortho-K

AL Change

(p value:<0.001) 0.54 ± 0.27 0.29 ± 0.27

RE Change −1.20 ± 0.61 2.09 ± 1.34

Curr Eye Res 2005; 30(1):71–80

CONCLUSION

Ortho-k may have both a

corrective and

preventive/control effect in

childhood myopia.

Retardation of Myopia in

Orthokeratology (ROMIO) Study

Single-masked randomized clinical trial

(Ortho-k lenses or SV glasses)

Ages from 6 to 10 years

Between -0.50 and -4.00 diopters



IOVS 2012;53:7077–7085 IOVS 2012;53:7077–7085

Optom Vis Sci 2013;90:530-539

partial reduction ortho-k and spectacles for residual refractive

errors in the daytime

Bifocal Contact Lens

Based on a case report involving

identical twins

Clin Exp Optom 2008; 91(4):

394–399

Baseline Year 1 Year 2

Twin A

BFL/BFL

-1.50

-1.50-0.25 x 110

-1.25 -0.25 x 160

-1.50 DS

-1.75 -0.50 x 165

-1.50 DS

Twin B

SVL/BFL

-1.25 -0.25 x 085

-1.50

-2.50 DS

-2.75 DS

-1.75 -0.50 x 162

-2.00 -0.50 x 012

DIMENZ

STUDY DESIGN

RCT 20-month clinical trial

with crossover

One eye bifocal SCL and

SV contact lens on other

eye for 10 months

Lens assignment swapped

between eyes from 11-20

months



DIMENZ

11–14 years old

-1.25 to -4.50 on non-cycloplegic subjective

refraction

myopia progression ≥ 0.50 D in the previous

12 months

1o outcome: cycloplegic autorefraction

Ophthalmology 2011;118:

1152–1161

With SVD With DF

lens

Difference

Period 1: Baseline to 10 months

Change in

refraction

-0.69 ± 0.38 -0.44 ± 0.33 0.25 ± 0.27

Period 2: Crossover to 20 months

Change in

refraction

-0.38 ± 0.38 -0.17 ± 0.35 0.20 ±0.34

Contact Lens Designed to Reduce

Relative Peripheral Hyperopia

Chinese children, aged 7 to 14 years, with

baseline myopia from sphere −0.75 to −3.50 D

Silicone hydrogel lens with a central zone that

corrected for the refractive error of the eye

Outside the central zone, the refracting power

of the lens increased progressively to +2.00 D

at the edge of the peripheral treatment zone

Relative peripheral refractive

error profile

IOVS 2011;52: 9362–9367 Multifocal Contact Lens Myopia Control

8 to 11 years old

Between -1.00 D and -6.00D

Fit with Proclear Multifocal with the distance

center design in both eyes and a +2.00 D add



Optometry and Vision Science,

Vol. 90, No. 11, November 2013

Multifocal (n) Single Vision (n)

Baseline -2.24 ± 0.06 (32) -2.26 ± 0.06 (32)

Year 1 -2.57 ± 0.06 (32) -2.86 ± 0.06 (32)

Year 2 -2.75 ± 0.06 (27) -3.28 ± 0.06 (27)

2-year change -0.51 ± 0.06 -1.03 ± 0.06

(p<0.0001)

Optometry and Vision Science,

Vol. 90, No. 11, November 2013

Slowed the growth of

the eye by ~29%