Patching vs atropine to treat amblyopia in children aged 7 to 12 years: a randomized trial

Arch Ophthalmol. 2008 Dec;126(12):1634-42. doi: 10.1001/archophthalmol.2008.107.

Abstract

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Amblyopia / drug therapy
  • Amblyopia / physiopathology
  • Amblyopia / therapy*
  • Atropine / therapeutic use*
  • Child
  • Female
  • Humans
  • Male
  • Mydriatics / therapeutic use*
  • Ophthalmic Solutions / therapeutic use
  • Sensory Deprivation*
  • Treatment Outcome
  • Vision, Binocular / physiology
  • Visual Acuity / physiology

Substances

  • Mydriatics
  • Ophthalmic Solutions
  • Atropine

Associated data

  • ClinicalTrials.gov/NCT00315328