A randomized trial of levodopa as treatment for residual amblyopia in older children.

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, 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: Pediatric Eye Disease Investigator Group, Michael X Repka, Raymond T Kraker, Trevano W Dean, Roy W Beck, R Michael Siatkowski, Jonathan M Holmes, Cynthia L Beauchamp, Richard P Golden, Aaron M Miller, Lisa C Verderber, David K Wallace
• Journal: Ophthalmology (Ophthalmology) Vol. 122 Issue 5 Pg. 874-81 (May 2015) ISSN: 1549-4713 [Electronic] United States
• PMID: 25676904 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Chemical References

• Dopamine Agents
• Levodopa

Topics

• Administration, Oral
• Amblyopia (etiology, physiopathology, therapy)
• Anisometropia (complications)
• Bandages
• Child
• Dopamine Agents (therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Levodopa (therapeutic use)
• Male
• Strabismus (complications)
• Treatment Outcome
• Visual Acuity (physiology)