Longitudinal Study of Levodopa/Carbidopa for Childhood Amblyopia

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Abstract
To determine the tolerability and efficacy of levodopa/ carbidopa combined with occlusion therapy for childhood amblyopia, a double-masked placebo-controlled randomized longitudinal study was performed on 10 amblyopic children between 6 and 14 years of age. Subjects received, on average, 20/5 mg levodopa/ carbidopa or 20 mg of placebo three times per day combined with part-time occlusion over a 3-week period. Visual function was assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts and by contrast sensitivity. Tolerability was assessed by questionnaire, SMAC (standard laboratory tests; consists of a chem 20 and complete blood count [CBC]) analysis, and physical examination. Compliance with occlusion and capsule consumption were assessed by questionnaire and by capsule count, respectively. At the end of the dosing regimen, the ìevoàopalcarbiàopa group significantly improved in visual acuity by 2.7 lines and in mean contrast sensitivity by 72% in the amblyopic eye. The placebo group improved in visual acuity by 1 .6 lines in the amblyopic eye. Tolerability and occlusion compliance were similar between groups; however, capsule ingestion compliance was significantly lower in the levodopa/carbidopa group. One month after the termination of treatment, the levodopa/carbidopa group maintained a significant 1.2-line improvement in visual acuity and 74% improvement in contrast sensitivity in the amblyopic eye. The placebo group did not maintain an improvement in visual acuity between the eyes. It is concluded that levodopa/carbidopa, at an average of 0.48/0.12 mg/kg, is well tolerated and, when combined with part-time occlusion, is efficacious in improving visual function in amblyopic children.

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