Pediatric Eye Disease Investigator Group (PEDIG)

Protocol: ATS09 - A Randomized Trial Comparing Patching to Atropine for Amblyopia in Children 7 to < 13 Years Old
Status: Closed
Start Date: 08/24/2005
End Date: 12/18/2007
Clinical Trial ID: NCT00315328
Public Dataset:  Download


A Randomized Trial Comparing Patching to Atropine for Amblyopia in Children 7 to < 13 Years Old

Protocol

Objectives: 

  1. To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in 7 to <13 years olds.
  2. To determine the maximum improvement with each treatment.

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.

Published:

  1. Pediatric Eye Disease Investigator Group. Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial. Arch Ophthalmol 2008;126:1634-42.
  2. Repka MX, Kraker RT, Beck RW, et al. Treatment of severe amblyopia with weekend atropine: results from 2 randomized trials. J AAPOS 2009;13:258-63.

 



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