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

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.

A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age.

PURPOSE: To compare visual acuity (VA) and binocularity outcomes in moderately hyperopic children with normal VA and binocularity assigned to glasses versus observation. DESIGN: Prospective randomized clinical trial (RCT). METHODS: One hundred nineteen 3- to 5-year-old children with hyperopia between +3.00D and +6.00D spherical equivalent were randomly assigned to glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or manifest strabismus). Follow-up occurred every 6 months. At 3 years, the treatment strategy was classified as "failed" if any of the following were met, both with and without correction: subnormal distance VA or stereoacuity; manifest strabismus; or strabismus surgery during follow-up. RESULTS: Of 84 (71%) children who completed the primary outcome examination, failure occurred in five (12%; 95% confidence interval [CI]: 4%-26%) of 41 assigned to glasses and four (9%; 95% CI: 3%-22%) of 43 assigned to observation (difference = 3%; 95% CI: -12%-18%; P = .72). Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29% (95% CI: 19%-43%) assigned to glasses and 27% (95% CI: 17%-42%) assigned to observation. CONCLUSIONS: In an RCT comparing glasses to observation for moderately hyperopic 3- to 5-year-old children with normal VA and binocularity, failure for VA or binocularity was not common. With insufficient enrollment and retention, our study was unable to determine whether immediate glasses prescription reduces failure rate, but low failure rates suggest that immediate glasses prescription for these children may not be needed to prevent failure for VA and/or binocularity.

The relationship between preoperative alignment stability and postoperative motor outcomes in children with esotropia.

PURPOSE: To examine the effect of preoperative alignment stability on postoperative motor outcomes in children who underwent surgery for esotropia. METHODS: One hundred sixty-seven subjects (68 with infantile esotropia and 99 with acquired esotropia) aged less than 6 years had surgery after completing 18 weeks of follow-up as part of an observational study. Preoperative alignment was classified as stable, uncertain, or unstable, based on measurements taken at baseline and every 6 weeks for 18 weeks. Distance alignment measured by prism and alternate cover test was compared among stability classification groups at 6 weeks and 6 months after surgery. RESULTS: Among subjects with infantile esotropia, median 6-week postoperative deviation was 2(Delta), 6(Delta), and 2(Delta) for subjects with stable, uncertain, and unstable preoperative alignment, respectively (p = 0.73 for stable vs unstable). Median 6-month postoperative deviation was 1(Delta), 9(Delta), and 1(Delta) for stable, uncertain, and unstable, respectively (p = 1.00 for stable vs unstable). Among subjects with acquired esotropia, median 6-week postoperative deviation was 6(Delta), 4(Delta), and 4(Delta) for subjects with stable, uncertain, and unstable preoperative alignment, respectively (p = 0.69 for stable vs unstable). Median 6-month postoperative deviation was 8(Delta), 4(Delta), and 6(Delta) for stable, uncertain, and unstable, respectively (p = 0.22 for stable vs unstable). CONCLUSIONS: Postoperative alignment at 6 weeks and 6 months appears similar in children with stable versus unstable preoperative esotropia. Nevertheless, our finding should be interpreted with caution due to small sample size.