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

ABSTRACT: To assess the efficacy and short-term safety of levodopa as adjunctive treatment to patching for amblyopia.Randomized, placebo-controlled trial.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.Sixteen weeks of oral levodopa or placebo administered 3 times daily while patching the fellow eye 2 hours daily.Mean change in best-corrected amblyopic-eye VA at 18 weeks.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.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.

SUBMITTER: Pediatric Eye Disease Investigator Group

PROVIDER: S-EPMC4414716 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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

Repka Michael X MX Kraker Raymond T RT Dean Trevano W TW Beck Roy W RW Siatkowski R Michael RM Holmes Jonathan M JM Beauchamp Cynthia L CL Golden Richard P RP Miller Aaron M AM Verderber Lisa C LC Wallace David K DK

Ophthalmology 20150209 5

<h4>Objective</h4>To assess the efficacy and short-term safety of levodopa as adjunctive treatment to patching for amblyopia.<h4>Design</h4>Randomized, placebo-controlled trial.<h4>Participants</h4>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.<h4>Methods</h4>Sixteen weeks of oral levodopa or placebo administered 3 times daily while patching the fellow eye ...[more]

PMID: 25676904

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Project description:Importance:Fellow eye patching has long been the standard treatment for amblyopia, but it does not always restore 20/20 vision or teach the eyes to work together. Amblyopia can be treated with binocular games that rebalance contrast between the eyes so that a child may overcome suppression. However, it is unclear whether binocular treatment is comparable to patching in treating amblyopia. Objectives:To assess the effectiveness of a binocular iPad (Apple Inc) adventure game as amblyopia treatment and compare this binocular treatment with patching, the current standard of care. Design, Setting, and Participants:This investigation was a randomized clinical trial with a crossover design at a nonprofit eye research institute. Between February 20, 2015, and January 4, 2016, a total of 28 patients were enrolled in the study, with 14 randomized to binocular game treatment and 14 to patching treatment. Interventions:Binocular game and patching as amblyopia treatments. Main Outcomes and Measures:The primary outcome was change in amblyopic eye best-corrected visual acuity (BCVA) at the 2-week visit. Secondary outcomes were change in stereoacuity and suppression at the 2-week visit and change in BCVA at the 4-week visit. Results:Among 28 children, the mean (SD) age at baseline was 6.7 (1.4) years (age range, 4.6-9.5 years), and 7 (25%) were female. At baseline, the mean (SD) amblyopic eye BCVA was 0.48 (0.14) logMAR (approximately 20/63; range, 0.3-0.8 logMAR [20/40 to 20/125]), with 14 children randomized to the binocular game and 14 to patching for 2 weeks. At the 2-week visit, improvement in amblyopic eye BCVA was greater with the binocular game compared with patching, with a mean (SD) improvement of 0.15 (0.08) logMAR (mean [SD], 1.5 [0.8] lines) vs 0.07 (0.08) logMAR (mean [SD], 0.7 [0.8] line; P?=?.02) after 2 weeks of treatment. These improvements from baseline were significant for the binocular game (mean [SD] improvement, 1.5 [0.8] lines; P?<?.001) and for patching (mean [SD] improvement, 0.7 [0.8] line; P?=?.006). Depth of suppression improved from baseline at the 2-week visit for the binocular game (mean [SD], 4.82 [2.82] vs 3.24 [2.87]; P?=?.03) and for patching (mean [SD], 4.77 [3.10] vs 2.57 [1.67]; P?=?.004). Patching children crossed over to binocular game treatment, and all 28 children played the game for another 2 weeks. At the 4-week visit, no group difference was found in BCVA change, with children who crossed over to the binocular games catching up with children treated with binocular games, for a mean (SD) improvement of 0.17 (0.10) logMAR (mean [SD], 1.7 [1.0] lines) for the binocular game vs a mean (SD) improvement of 0.16 (0.12) logMAR (mean [SD], 1.6 [1.2] lines) for the patching crossover (P?=?.73). Conclusions and Relevance:A binocular iPad game was effective in treating childhood amblyopia and was more efficacious than patching at the 2-week visit. Binocular games that rebalance contrast to overcome suppression are a promising additional option for treating amblyopia. Trial Registration:clinicaltrials.gov Identifier: NCT02365090.

Project description:PURPOSE:To compare visual acuity (VA) improvement in children aged 7 to 12 years with amblyopia treated with a binocular iPad game plus continued spectacle correction vs. continued spectacle correction alone. DESIGN:Multicenter randomized clinical trial. PARTICIPANTS:One hundred thirty-eight participants aged 7 to 12 years with amblyopia (33-72 letters, i.e., approximately 20/200 to 20/40) resulting from strabismus, anisometropia, or both. Participants were required to have at least 16 weeks of optical treatment in spectacles if needed or demonstrate no improvement in amblyopic-eye visual acuity (VA) for at least 8 weeks prior to enrollment. METHODS:Eligible participants (mean age 9.6 years, mean baseline VA of 59.6 letters, history of prior amblyopia treatment other than spectacles in 96%) were randomly assigned to treatment for 8 weeks with the dichoptic binocular Dig Rush iPad game (prescribed for 1 hour per day 5 days per week) plus spectacle wear if needed (n = 69) or continued spectacle correction alone if needed (n = 69). MAIN OUTCOME MEASURES:Change in amblyopic-eye VA from baseline to 4 weeks, assessed by a masked examiner. RESULTS:At 4 weeks, mean amblyopic-eye VA letter score improved from baseline by 1.3 (2-sided 95% confidence interval [CI]: 0.1-2.6; 0.026 logMAR) with binocular treatment and by 1.7 (2-sided 95% CI: 0.4-3.0; 0.034 logMAR) with continued spectacle correction alone. After adjusment for baseline VA, the letter score difference between groups (binocular minus control) was -0.3 (95% CI: -2.2 to 1.5, P = 0.71, difference of -0.006 logMAR). No difference in letter scores was observed between groups when the analysis was repeated after 8 weeks of treatment (adjusted mean: -0.1, 98.3% CI: -2.4 to 2.1). For the binocular group, adherence data from the iPad indicated that slightly more than half of the participants (58% and 56%) completed >75% of prescribed treatment by the 4- and 8-week visits, respectively. CONCLUSIONS:In children aged 7 to 12 years who have received previous treatment for amblyopia other than spectacles, there was no benefit to VA or stereoacuity from 4 or 8 weeks of treatment with the dichoptic binocular Dig Rush iPad game.

Project description:SignificanceBinocular treatment for unilateral amblyopia is an emerging treatment that requires evaluation through a randomized clinical trial.PurposeThis study aimed to compare change in amblyopic-eye visual acuity (VA) in children aged 4 to 6 years treated with the dichoptic binocular iPad (Apple, Cupertino, CA) game, Dig Rush (not yet commercially available; Ubisoft, Montreal, Canada), plus continued spectacle correction versus continued spectacle correction alone.MethodsChildren (mean age, 5.7 years) were randomly assigned to home treatment for 8 weeks with the iPad game (prescribed 1 h/d, 5 d/wk [n = 92], or continued spectacle correction alone [n = 90]) in a multicenter randomized clinical trial. Before enrollment, children wearing spectacles were required to have at least 16 weeks of wear or no improvement in amblyopic-eye VA (<0.1 logMAR) for at least 8 weeks. Outcome was change in amblyopic-eye VA from baseline to 4 weeks (primary) and 8 weeks (secondary) assessed by masked examiner.ResultsA total of 182 children with anisometropic (63%), strabismic (16%; <5∆ near, simultaneous prism and cover test), or combined-mechanism (20%) amblyopia (20/40 to 20/200; mean, 20/63) were enrolled. After 4 weeks, mean amblyopic VA improved by 1.1 logMAR lines with binocular treatment and 0.6 logMAR lines with spectacles alone (adjusted difference, 0.5 lines; 95.1% confidence interval [CI], 0.1 to 0.9). After 8 weeks, results (binocular treatment: mean amblyopic-eye VA improvement, 1.3 vs. 1.0 logMAR lines with spectacles alone; adjusted difference, 0.3 lines; 98.4% CI, -0.2 to 0.8 lines) were inconclusive because the CI included both zero and the pre-defined difference in mean VA change of 0.75 logMAR lines.ConclusionsIn 4- to 6-year-old children with amblyopia, binocular Dig Rush treatment resulted in greater improvement in amblyopic-eye VA for 4 weeks but not 8 weeks. Future work is required to determine if modifications to the contrast increment algorithm or other aspects of the game or its implementation could enhance the treatment effect.

Dataset Information

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

Publications

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

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