A randomized trial of levodopa as treatment for residual amblyopia in older children.
To assess the efficacy and short-term safety of levodopa as adjunctive treatment to patching for amblyopia.Randomized, placebo-controlled trial.One hundred thirty-nine children 7 to 12 years of age with residual amblyopia resulting from strabismus, anisometropia, or both combined (visual acuity [VA], 20/50-20/400) after patching.Sixteen weeks of oral levodopa or placebo administered 3 times daily while patching the fellow eye 2 hours daily.Mean change in best-corrected amblyopic-eye VA at 18 weeks.At 18 weeks, amblyopic-eye VA improved from randomization by an average of 5.2 letters in the levodopa group and by 3.8 letters in the placebo group (difference adjusted for baseline VA, +1.4 letters; 1-sided P=0.06; 2-sided 95% confidence interval, -0.4 to 3.3 letters). No serious adverse effects from levodopa were reported during treatment.For children 7 to 12 years of age with residual amblyopia after patching therapy, oral levodopa while continuing to patch 2 hours daily does not produce a clinically or statistically meaningful improvement in VA compared with placebo and patching.
Pediatric Eye Disease Investigator Group, ; Repka, MX; Kraker, RT; Dean, TW; Beck, RW; Siatkowski, RM; Holmes, JM; Beauchamp, CL; Golden, RP; Miller, AM; Verderber, LC; Wallace, DK
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