To compare patching and atropine as treatments for moderate amblyopia in children younger than 7 years. Methods: In a randomized clinical trial, 419 children younger than 7 years with amblyopia and visual acuity in the range of 20/40 to 20/100 were assigned to receive either patching or atropine at 47 clinical sites. Main Outcome Measure: Visual acuity in the amblyopic eye and sound eye after 6 months. Results: Visual acuity in the amblyopic eye improved in both groups (improvement from baseline to 6 months was 3.16 lines in the patching group and 2.84 lines in the atropine group). Improvement was initially faster in the patching group, but after 6 months, the difference in visual acuity between treatment groups was small and clinically inconsequential (mean difference at 6 months, 0.034 logMAR units; 95% confidence interval, 0.005-0.064 logMAR units). The 6-month acuity was 20/30 or better in the amblyopic eye and/or improved from baseline by 3 or more lines in 79% of the patching group and 74% of the atropine group. Both treatments were well tolerated, although atropine had a slightly higher degree of acceptability on a parental questionnaire. More patients in the atropine group than in the patching group had reduced acuity in the sound eye at 6 months, but this did not persist with further follow-up. Conclusion: Atropine and patching produce improvement of similar magnitude, and both are appropriate modalities for the initial treatment of moderate amblyopia in children aged 3 to less than 7 years.

Initial treatment for amblyopia of the fellow eye with patching and atropine sulfate eyedrops improves visual acuity. Long-term data on the durability of treatment benefit are needed.OBJECTIVE To report visual acuity at 15 years of age among patients who were younger than 7 years when enrolled in a treatment trial for moderate amblyopia. DESIGN, SETTING, AND PARTICIPANTSIn a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40 to 20/100) were randomly assigned to patching (minimum of 6 h/d) or atropine sulfate eyedrops, 1% (1 drop daily), for 6 months. Treatment after 6 months was at the discretion of the investigator. Two years after enrollment, an unselected subgroup of 188 children were enrolled into long-term follow-up. INTERVENTION Initial treatment with patching or atropine with subsequent treatment at investigator discretion. MAIN OUTCOMES AND MEASURES Visual acuity at 15 years of age with the electronic Early Treatment Diabetic Retinopathy Study test in amblyopic and fellow eyes. RESULTS Mean visual acuity in the amblyopic eye measured in 147 participants at 15 years of age was 0.14 logMAR (approximately 20/25); 59.9% of amblyopic eyes had visual acuity of 20/25 or better and 33.3%, 20/20 or better. Mean interocular acuity difference (IOD) at 15 years of age was 0.21 logMAR (2.1 lines); 48.3% had an IOD of 2 or more lines and 71.4%, 1 or more lines. Treatment (other than spectacles) was prescribed for 9 participants (6.1%) aged 10 to 15 years. Mean IOD was similar at examinations at 10 and 15 years of age (2.0 and 2.1 logMAR lines, respectively; P = .39). Better visual acuity at the 15-year examination was achieved in those who were younger than 5 years at the time of entry into the randomized clinical trial (mean logMAR, 0.09) compared with those aged 5 to 6 years (mean logMAR, 0.18; P < .001). When we compared subgroups based on original treatment with atropine or patching, no significant differences were observed in visual acuity of amblyopic and fellow eyes at 15 years of age (P = .44 and P = .43, respectively).CONCLUSIONS AND RELEVANCE At 15 years of age, most children treated for moderate amblyopia when younger than 7 years have good visual acuity, although mild residual amblyopia is common. The outcome is similar regardless of initial treatment with atropine or patching. The results indicate that improvement occurring with amblyopia treatment is maintained until at least 15 years of age. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00000170

Objectives-To determine the visual acuity outcome at 10 years of age for children less than 7 years of age when enrolled in a treatment trial for moderate amblyopia.Methods-In a multi-center clinical trial, 419 children with amblyopia (20/40 to 20/100) were randomized to patching or atropine eye drops 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 ETDRS test.Results-The mean amblyopic eye acuity, measured in 169 patients, at age 10 years was 0.17 logMAR (approximately 20/32) and 46% of amblyopic eyes were 20/25 or better. Age < 5 years at the time of entry into the randomized trial was associated with a better visual acuity outcome (P<0.001). Mean amblyopic and sound eye visual acuities at age 10 years were similar in the original treatment groups (P= 0.56 and 0.80, respectively). Conclusion-Atage 10 years the improvement of the amblyopic eye is maintained, although residual amblyopia is common following treatment initiated at 3 to <7 years of age. The outcome is similar regardless of initial treatment with atropine or patching.Application to Clinical Practice-Patching and atropine eye drops produce comparable improvement in visual acuity that is maintained through age 10 years.

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