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A Randomized Trial

Pediatric Eye Disease Investigator Group^*

Arch Ophthalmol. 2008;126(12):1634-1642.

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

*Writing Committee: The following members of the Pediatric Eye Disease Investigator Group Writing Committee take authorship responsibility for this study: Mitchell M. Scheiman, OD (lead author); Richard W. Hertle, MD (lead author); Raymond T. Kraker, MSPH (lead author); Roy W. Beck, MD, PhD; Eileen E. Birch, PhD; Joost Felius, PhD; Jonathan M. Holmes, BM, BCh; James Kundart, MD; David G. Morrison, MD; Michael X. Repka, MD; and Susanna M. Tamkins, OD.

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