AMBLYOPIA TREATMENT STUDIES

AMBLYOPIA TREATMENT STUDIES

SIVA TEJA CHALLA

PEDIG• Pediatric Eye Disease Investigator Group: (PEDIG) is a

collaborative network dedicated to facilitating multicenter clinical research in strabismus, amblyopia and other eye disorders that affect children.

• The network, which was formed in 1997, is funded by the National Eye Institute (NEI)

In the ATS,mild to moderate amblyopia VA in the amblyopic eye of 6/24 or better;severe amblyopia is VA in the amblyopic eye of 6/60 to 6/120.

Amblyopia Treatment Study ATS 1

• A randomized trial of atropine versus patching for treatment of moderate amblyopia in children

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• OBJECTIVES To compare patching and atropine as treatments for moderate amblyopia in 3 to <7 years old

• STUDY DESIGN 419 childre <7 years with amblyopia and VA in the range of 6/12 to 6/60 were assigned to receive either patching or atropine

• MAIN OUTCOME MEASURE: VA in the amblyopic eye and sound eye after 6 months.

RESULTS: 1.VA improved in both groups 3.16 lines in patching and 2.84 lines in atropine group (mean diff 0.24 lines) 2.VA >6/9 and/or improved by more than 3 lines in 79% in patching and 74% in atropine group

CONCLUSION

CONCLUSION:

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• Study was continued further and VA in the amblyopic eye and sound eye after 2 years was measured• RX was at the discretion of the investigator

RESULTS VA improved in both groups: 3.7 lines in occlusion group CONCLUSIONS: Atropine or patching for 6 months followed by best clinical care until 2 years produced similar improvement of moderate amblyopia. BUT, on average the amblyopic eye acuity was still approximately 2 lines worse than the sound eye.

Amblyopia Treatment Study ATS 2A,2BATS 2AOBJECTIVE: To compare full-time patching (all hours) to 6 hours of patching per day, as prescribed treatments for severe amblyopia in children younger than 7 years

FULL TIME

VS

PART TIME

PARTICIPANTS: 175 children <7 years with amblyopia in the range of 6/60 to 6/120

MAIN OUTCOME MEASURE: VA in the amblyopic eye after 4 months

RESULTS : improvement in the amblyopic eye VA from baseline to 4 months averaged 4.8 lines in the 6-hour group and 4.7 lines in the full-time group

CONCLUSION:

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FULL TIME PART TIME

ATS 2BOBJECTIVE: To compare 2 hours vs 6 hours of daily patching as treatments for moderate amblyopia in <7 years

2 HRS VS 6 HRS

PARTICIPANTS: 189 children <7 years with amblyopia in the range of 6/12 to 6/24 assigned To 2 hrs or 6 hrs of daily patching

MAIN OUTCOME MEASURE: VA in the amblyopic eye after 4 months.

RESULTS: The improvement in the visual acuity of the amblyopic eye from baseline to 4 months averaged 2.40 lines in each group

CONCLUSION:

2 HRS = 6 HRS

AMBLYOPIA TREATMENT STUDY ATS 3

• OBJECTIVE: To evaluate the effectiveness of treatment of amblyopia in children aged 7 to 17 years.

• MAIN OUTCOME MEASURE: VA in the amblyopic eye after 6 months

• PARTICIPANTS: 507 patients with amblyopic eye visual acuity ranging from 6/12 to 6/120Control Group: • Optical correction only

Active Treatment Group: • Optical correction• Patching 2-6 hours daily• At least 1 hour of near activities daily during patching • Atropine 1% one drop daily (pts <13 yrs only)

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ATS 3 RESULTS

MODERATE AMBLYOPIA SEVERE AMBLYOPIA

7-13 YRS 13-17 YRS 7-13 YRS 13-17 YRS

36%achieved 6/7.5 or better combined group with 14% with optical correction alone

14% achieved 6/7.5 or better with optical correction/occlusion compared with 11% with optical correction alone

14% achieved 6/7.5 or better with optical correction/occlusion compared with 11% with optical correction alone

14% achieved 6/12 or better with optical correction/occlusion compared with 0% with optical correction alone

CONCLUSIONS

• Amblyopia improves with optical correction alone in about one fourth of patients aged 7 to 17 years,

• For patients aged 7 to 12 years, prescribing 2 to 6 hours per day of patching with near visual activities and atropine can improve visual acuity even if the amblyopia has been previously treated.

• For patients 13 to 17 years, prescribing patching 2 to 6 hours per day with near visual activities may improve visual acuity when amblyopia has not been previously treated


DAILY VS WEEKEND

PARTICIPANTS: 168 CHILDREN <7 years with amblyopia in the range of 6/12 to 6/24 associated with strabismus, anisometropia, or both

MAIN OUTCOME MEASURE: VA in the amblyopic eye after 4 months.

RESULTS: The VA of the amblyopic eye at study completion was either (1) at least 6/7.5 or (2) better than or equal to that of the sound eye in 39 children (47%) in the daily group and 45 children (53%) in the weekend group

CONCLUSION ATS4

DAILY = WEEKEND


OBJECTIVE To evaluate the effectiveness of refractive correction alone for the treatment of untreated anisometropic amblyopia in children 3 to <7 years old.

PARTICIPANTS: 84 children 3 to <7 years old with untreated anisometropic amblyopia ranging from 6/12 to 6/75

METHODS: Optimal refractive correction was provided, and visual acuity (VA) at baseline and at 5-week intervals until VA stabilized or amblyopia resolved

MAIN OUTCOME MEASURE: Maximum improvement in BCVA in the amblyopic eye and proportion of children whose amblyopia resolved (interocular difference of < or =1 line) with refractive correction alone.

RESULTS: Amblyopia improved with optical correction by > or =2 lines in 77% and resolved in 27%. Improvement took up to 30 weeks for stabilization criteria to be met

CONCLUSION: Refractive correction alone improves VA in many cases and results in resolution of amblyopia in at least one third of 3- to <7-year-old children with untreated anisometropic amblyopia

AMBLYOPIA TREATMENT STUDY ATS 5(2)OBJECTIVE 2 hours of daily patching (combined with 1 hour of concurrent near visual activities) VS control group of spectacle wear alone for treatment of moderate to severe amblyopia in children 3 to 7 years old.

VS

PARTICIPANTS: 180 children 3 to 7 years old with BCVA amblyopic-eye (VA) of 6/12 to 6/120 associated with strabismus, anisometropia, or both who had worn optimal refractive correction for at least 16 weeks or for 2 consecutive visits without improvement

INTERVENTION: Randomization either to 2 hours of daily patching with 1 hour of near visual activities or to spectacles alone

METHODS: visual acuity (VA) was measured at baseline and at 5-week intervals until VA stabilized or amblyopia resolved

MAIN OUTCOME MEASURE: Best-corrected VA in the amblyopic eye after 5 weeks

RESULTS: Improvement in VA of the amblyopic eye from baseline to 5 weeks averaged 1.1 lines in the patching group and 0.5 lines in the spectacles alone

• CONCLUSION: After a period of treatment with spectacles, 2 hours of daily patching combined with 1 hour of near visual activities modestly improves moderate to severe amblyopia in children 3 to 7 years old.

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AMBLYOPIA TREATMENT STUDY ATS 6OBJECTIVE To determine whether performing near activities while patching for amblyopia enhances improvement in visual acuity.

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PARTICIPANTS: 425 children,3 to <7 yrs, with amblyopia (6/12-6/120) that was caused by anisometropia, strabismus, or both, and that persisted after treatment with spectacles

METHODS: 2 hours of patching per day with near activities or 2 hours of patching per day with distance activities. Study visits were scheduled at 2, 5, 8, and 17 weeks.

MAIN OUTCOME MEASURE: Masked assessment of VA at 8 weeks

RESULTS: At 8 weeks, improvement in amblyopic eye visual acuity averaged 2.6 lines in the distance activities group and 2.5 lines in the near activities group

CONCLUSION: Performing common near activities does not improve VA when treating anisometropic, strabismic, or combined amblyopia with 2 hrs of daily patching.

Children with severe amblyopia may respond to 2 hours of daily patching

AMBLYOPIA TREATMENT STUDY ATS 7OBJECTIVE To determine the amount and time course of binocular visual acuity improvement during treatment of bilateral refractive amblyopia in 3 - <10 years of age

METHODS: 113 children with previously untreated bilateral refractive amblyopia were provided with optimal spectacle correction. Bilateral refractive amblyopia was defined as 6/12 to 6/120 best-corrected binocular visual acuity in the presence of 4.00 D or more of hypermetropia , 2.00 D or more of astigmatism, or both in each eye. Best-corrected binocular and monocular visual acuities were measured at baseline and at five, 13, 26, and 52 weeks

MAIN OUTCOME MEASURE: The primary study outcome was binocular acuity at one yearRESULTS: Binocular VA improved on average 3.9 lines, At 1 year, 74% had binocular VA of 6/7.5 or betterCONCLUSION: Treatment of bilateral refractive amblyopia with spectacle correction improves binocular visual acuity in children three to less than 10 years of age, with most improving to 6/7.5 or better within one year

AMBLYOPIA TREATMENT STUDY ATS 8OBJECTIVE To compare weekend atropine sulfate use augmented by a plano lens for the sound eye with weekend atropine use alone for moderate amblyopia in children aged 3 years to younger than 7 years.

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PARTICIPANTS: 180 children with moderate amblyopia (visual acuities of 6/12-6/30) were randomized to weekend atropine use augmented by a plano lens or weekend atropine use alone.MAIN OUTCOME MEASUREMasked assessment of amblyopic eye visual acuity at 18 weeks. RESULTS: Amblyopic eye VA was 6/7.5 or better in 29% of the atropine only group and in 40% of the atropine plus plano lens group(P <0.03)CONCLUSION: : As an initial treatment for moderate amblyopia, the augmentation of weekend atropine use with a plano lens does not substantially improve amblyopic eye visual acuity when compared with weekend atropine use alone.


OBJECTIVE patching with atropine eyedrops in the treatment of moderate amblyopia (visual acuity, 6/12-6/30) in children aged 7 to 12 years.

vs

PARTICIPANTS: 193 children with amblyopia were assigned to receive weekend atropine or patching of the sound eye 2 hours per day

MAIN OUTCOME MEASURE VA in the amblyopic eye at 17 weeks.

RESULTS: At 17 weeks, visual acuity had improved from baseline by an average of 7.6 letters in the atropine group and 8.6 letters in the patching group.

amblyopic va of 6/7.5 or better in 17% of atropine group and 24% of patching group

CONCLUSION: : Treatment with atropine or patching led to similar degrees of improvement among 7- to 12-year-olds with moderate amblyopia.


OBJECTIVE To determine whether visual acuity improvement with Bangerter filters is similar to improvement with patching as initial therapy for children with moderate amblyopia.

PARTICIPANTS:186 children, 3 to <10 years old, with moderate amblyopia (6/12–6/24)

MAIN OUTCOME MEASURE Children were randomly assigned to receive either daily patching or to use a Bangerter filter on the spectacle lens in front of the fellow eye. Study visits were scheduled at 6, 12, 18, and 24 weeks.Visual acuity in amblyopic eyes at 24 weeks.

RESULTS: Similar improvement in VA in both groups• Amblyopic eye VA of 6/7.5 or better in 36% of Bangerter group and

31% of patching group (P=0.86)

CONCLUSION: : Because the average difference in VA improvement between Bangerter filters and patching was less than half a line, Bangerter filter treatment is a reasonable option to consider for initial treatment of moderate amblyopia.


OBJECTIVE Randomized trial to evaluate combined patching and atropine for residual amblyopia IN 3 TO <10YR age groupPARTICIPANTS: 55 children,3-<10 with strabismic and/or anisometropic amblyopia, best-corrected amblyopic eye acuity of 20/32 to 20/63, interocular acuity difference greater than or equal to 2 lines, and no improvement in amblyopic eye acuity between 2 consecutive visits at least 6 weeks apart

• Before enrollment, eligible subjects had no improvement with 6 hours daily patching or daily atropine• Intensive treatment group had 6 hours of prescribed daily

patching combined with daily atropine; weaning group had 4 weeks of reduced treatment, then stopped• Amblyopic eye VA improved similarly in both groups, an average

of 0.56 lines in the intensive group• The study was stopped on recommendation of the data and

safety monitoring committee• slow recruitment • conditional power analysis indicating that the study was

unlikely to find a statistically significant benefit

Intensive final push of combined treatment with patching and daily atropine did not produce a better visual acuity outcome after 10 weeks


A randomized trial comparing patching with active vision therapy to patching with control vision therapy as treatment for amblyopia in children 7 to < 13 years old

Nineteen children,with amblyopia (6/12-6/60) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy.

The study was terminated due to difficulty in recruitment under the proposed eligibility criteria

ATS 13OBJECTIVE VA improvement in children with strabismic and combined strabismic-anisometropic amblyopia treated with optical correction alonePARTICIPANTS:146 children 3 to <7 years old with previously untreated strabismic amblyopia or combined-mechanismamblyopia METHODS Optical treatment was provided as spectacles that were worn for the first time at the baseline visit. VA measured at baseline and every 9 weeks thereafter until no further improvement in visual acuity. Ocular alignment was assessed at each visit.MAIN OUTCOME MEASURE Visual acuity 18 weeks after baseline.

RESULTS: Mean 2.6 lines improvement 75% improved ≥2 lines and 54% improved ≥3 lines Resolution in 32% Treatment effect was greater for strabismic amblyopia than for combined-mechanism amblyopia CONCLUSION: :Consideration should be given to prescribing refractive correction as the sole initial treatment for children with strabismic or combined-mechanism amblyopia before initiating other therapies.

ATS 14A PILOT STUDY TO EVALUATE LEVODOPA AS TREATMENT FOR RESIDUAL AMBLYOPIA IN 8-17 YEARS OLDAt the time of enrollment, subjects were required to have been

treated with at least 2 hours per day of daily patching with STABLE VAIntervention: • continuing 2 hours of daily patching• addition of levodopa in one of two doses randomly assigned with equal

probability (0.51 or 0.76 mg/kg/tid, referred to as lower dose and higher dose, respectively).

• The study medication was administered for 8 weeks with one additional week for tapering of treatment.

• Levodopa was prepared in capsules combined with carbidopa 0.17 mg/kg/tid.

• Carbidopa was combined with levodopa to reduce side-effects associated with levodopa alone.

• RESULTS• The mean improvement in amblyopic eye in 9-week primary outcome visit

was +4 (±4) letters in the 16 subjects in the lower dose group and +6 (±6) letters in the 17 subjects in the higher dose group

• An improvement of 10 or more letters noted in 2 (13%) in low dose, and 5 (29%) in high dose group at 9 wks

• Fellow eye improved 1 letter in high dose and zero letter is low dose group

Justification: Small sample, experience with drug, promising result

ATS 15: INCREASING PATCHING FOR AMBLYOPIA STUDY FROM 2 HOURS TO 6 HOURS, 3 TO <8, 20/50 TO 20/400

• When amblyopic eye VA stops improving with 2 hours of daily patching, increasing the daily patching dosage to 6 hours results in more improvement in VA after 10 weeks compared with continuing 2 hours daily.

ON GOING TRAILS

• ATS 16: Augmenting atropine treatment for amblyopia in 3 to <8, 20/50 to 20/400 with plano lens to sound eye• ATS 17A: Randomized trial of levodopa as treatment

for residual amblyopia

REFERENCES

• http://pedig.jaeb.org/Publications.aspx

• http://www.abcd-vision.org/amblyopia/ats-pedig.html

http://pedig.jaeb.org/Publications.aspx

http://pedig.jaeb.org/Publications.aspx

THANK YOU

AMBLYOPIA TREATMENT STUDIES

Health & Medicine

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