Binocular iPad Game vs Patching for Treatment of Amblyopia in Children

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 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.