Michael X Repka1, Raymond T Kraker2, Trevano W Dean2, Roy W Beck2, R Michael Siatkowski3, Jonathan M Holmes4, Cynthia L Beauchamp5, Richard P Golden6, Aaron M Miller7, Lisa C Verderber8, David K Wallace9. 1. Wilmer Ophthalmological Institute, Johns Hopkins University, Baltimore, Maryland. Electronic address: pedig@jaeb.org. 2. Jaeb Center for Health Research, PEDIG Coordinating Center, Tampa, Florida. 3. Dean McGee Eye Institute, University of Oklahoma, Oklahoma City, Oklahoma. 4. Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota. 5. Pediatric Ophthalmology and Adult Strabismus PA, Dallas, Texas. 6. Department of Ophthalmology, Nationwide Children's Hospital, Columbus, Ohio. 7. Houston Eye Associates, The Woodlands, Texas. 8. Pediatric Eye Associates, Wilmette, Illinois. 9. Duke Eye Center, Durham, North Carolina.
Abstract
OBJECTIVE: To assess the efficacy and short-term safety of levodopa as adjunctive treatment to patching for amblyopia. DESIGN: Randomized, placebo-controlled trial. PARTICIPANTS: 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. METHODS: Sixteen weeks of oral levodopa or placebo administered 3 times daily while patching the fellow eye 2 hours daily. MAIN OUTCOME MEASURES: Mean change in best-corrected amblyopic-eye VA at 18 weeks. RESULTS: 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. CONCLUSIONS:For children 7 to 12 years of age with residual amblyopia after patching therapy, orallevodopa while continuing to patch 2 hours daily does not produce a clinically or statistically meaningful improvement in VA compared with placebo and patching.
RCT Entities:
OBJECTIVE: To assess the efficacy and short-term safety of levodopa as adjunctive treatment to patching for amblyopia. DESIGN: Randomized, placebo-controlled trial. PARTICIPANTS: 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. METHODS: Sixteen weeks of oral levodopa or placebo administered 3 times daily while patching the fellow eye 2 hours daily. MAIN OUTCOME MEASURES: Mean change in best-corrected amblyopic-eye VA at 18 weeks. RESULTS: 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. CONCLUSIONS: 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.
Authors: David K Wallace; Allison R Edwards; Susan A Cotter; Roy W Beck; Robert W Arnold; William F Astle; Carmen N Barnhardt; Eileen E Birch; Sean P Donahue; Donald F Everett; Joost Felius; Jonathan M Holmes; Raymond T Kraker; Michele Melia; Michael X Repka; Nicholas A Sala; David I Silbert; Katherine K Weise Journal: Ophthalmology Date: 2006-06 Impact factor: 12.079
Authors: Michael X Repka; Raymond T Kraker; Roy W Beck; C Scott Atkinson; Darron A Bacal; Don L Bremer; Patricia L Davis; Matthew D Gearinger; Stephen R Glaser; Darren L Hoover; Daniel M Laby; David G Morrison; David L Rogers; Nicholas A Sala; Donny W Suh; Maynard B Wheeler Journal: Arch Ophthalmol Date: 2010-09
Authors: L E Leguire; P D Walson; G L Rogers; D L Bremer; M L McGregor Journal: J Pediatr Ophthalmol Strabismus Date: 1993 Nov-Dec Impact factor: 1.402
Authors: Lawrence E Leguire; Kelly L Komaromy; Theresa M Nairus; Gary L Rogers Journal: J Pediatr Ophthalmol Strabismus Date: 2002 Nov-Dec Impact factor: 1.402
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