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Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial
Mitchell M Scheiman1, Richard W Hertle, Raymond T Kraker
1Jaeb Center for Health Research, Tampa, FL 33647, USA. pedig@jaeb.org
Insights
Patching and atropine eyedrops showed similar effectiveness in treating moderate amblyopia in children aged 7-12. Both treatments improved visual acuity, with about 1 in 5 achieving 20/25 vision.
Area of Science:
- Ophthalmology
- Pediatric Medicine
- Clinical Trials
Background:
- Amblyopia, or "lazy eye," affects visual development in children.
- Current treatments include patching and atropine eyedrops.
- This study evaluated these treatments in older children.
Purpose of the Study:
- To compare the efficacy of patching versus atropine eyedrops for moderate amblyopia.
- To assess treatment outcomes in children aged 7 to 12 years.
- To determine if atropine is non-inferior to patching.
Main Methods:
- A randomized, multicenter clinical trial.
- 193 children with amblyopia were assigned to either weekend atropine or 2-hour daily patching.
- Visual acuity was assessed at 17 weeks using a standardized protocol.
Main Results:
- Both atropine and patching groups showed similar average visual acuity improvements (7.6 vs. 8.6 letters).
- The difference between groups met the criteria for equivalence.
- Approximately 17% of the atropine group and 24% of the patching group achieved 20/25 or better vision.
Conclusions:
- Patching and atropine eyedrops yield comparable results for moderate amblyopia in children aged 7-12.
- Both treatments are effective in improving visual acuity.
- About one-fifth of children achieved good visual outcomes with either method.
Objective:
To compare patching with atropine eyedrops in the treatment of moderate amblyopia (visual acuity, 20/40-20/100) in children aged 7 to 12 years.
Methods:
In a randomized, multicenter clinical trial, 193 children with amblyopia were assigned to receive weekend atropine or patching of the sound eye 2 hours per day. Main Outcome Measure Masked assessment of visual acuity in the amblyopic eye using the electronic Early Treatment Diabetic Retinopathy Study testing protocol 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. The mean difference between groups (patching - atropine) adjusted for baseline acuity was 1.2 letters (ends of complementary 1-sided 95% confidence intervals for noninferiority, -0.7, 3.1 letters). This difference met the prespecified definition for equivalence (confidence interval <5 letters). Visual acuity in the amblyopic eye was 20/25 or better in 15 participants in the atropine group (17%) and 20 in the patching group (24%; difference, 7%; 95% confidence interval, -3% to 17%).
Conclusions:
Treatment with atropine or patching led to similar degrees of improvement among 7- to 12-year-olds with moderate amblyopia. About 1 in 5 achieved visual acuity of 20/25 or better in the amblyopic eye.
Clinical Relevance:
Atropine and patching achieve similar results among older children with unilateral amblyopia.
Trial Registration:
(clinicaltrials.gov) Identifier: NCT00315328.
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