Conditions: Amblyopia
Keywords: amblyopia, levodopa
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 139
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of oral levodopa and patching versus oral placebo and patching as treatment for residual amblyopia in children 7 to \<13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.

Detailed description:
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal visual acuity in the amblyopic eye. In a previous PEDIG study where children 7 to 12 years old were treated with atropine and patching, only 36% of the children with moderate amblyopia and only 23% of the children with severe amblyopia achieved 20/40 or better acuity.

Many clinicians have recognized that conventional therapies with patching and atropine have not been universally successful and have sought alternatives. PEDIG has discussed for several years the problem of residual amblyopia and how the remaining visual acuity deficit could be reduced. A number of research groups have evaluated the short term use of oral levodopa-carbidopa as an adjunct to patching therapy for older children.

Arms:
arm 1: Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid arm 2: Oral placebo tid

Interventions: intervention 1: Levodopa/Carbidopa intervention 2: Placebo intervention 3: Patching
Intervention descriptions: intervention 1: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid intervention 2: Oral placebo tid intervention 3: Two hours of daily patching

Protocol document: