A Randomized Trial of Atropine vs Patching for Treatment of Moderate Amblyopia

Abstract

Objective To determine the visual acuity outcome at age 10 years for children younger than 7 years when enrolled in a treatment trial for moderate amblyopia. Methods In a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40-20/100) were randomized to patching or atropine eyedrops for 6 months. Two years after enrollment, a subgroup of 188 children entered long-term follow-up. Treatment after 6 months was at the discretion of the investigator; 89% of children were treated. Main Outcome Measure Visual acuity at age 10 years with the electronic Early Treatment Diabetic Retinopathy Study test. Application to Clinical Practice Patching and atropine eyedrops produce comparable improvement in visual acuity that is maintained through age 10 years. Results The mean amblyopic eye acuity, measured in 169 patients, at age 10 years was 0.17 logMAR (logarithm of the minimum angle of resolution) (approximately 20/32), and 46% of amblyopic eyes had an acuity of 20/25 or better. Age younger than 5 years at entry into the randomized trial was associated with a better visual acuity outcome (P < .001). Mean amblyopic and sound eye visual acuities at age 10 years were similar in the original treatment groups (P = .56 andP = .80, respectively). Conclusions At age 10 years, the improvement of the amblyopic eye is maintained, although residual amblyopia is common after treatment initiated at age 3 years to younger than 7 years. The outcome is similar regardless of initial treatment with atropine or patching. Trial Registration clinicaltrials.gov Identifier:NCT00000170