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



  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.

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.

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%).

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.


  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.