@article {1629474, title = {A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years of Age}, journal = {Optom Vis Sci}, year = {2022}, month = {2022 Jan 24}, abstract = {SIGNIFICANCE: Binocular treatment for unilateral amblyopia is an emerging treatment that requires evaluation through a randomized clinical trial. PURPOSE: To compare change in amblyopic eye visual acuity (VA) in children aged 4 to 6 years treated with the dichoptic binocular Dig Rush iPad game plus continued spectacle correction vs. continued spectacle correction alone. METHODS: Children (mean 5.7 years) were randomly assigned to home treatment for 8 weeks with the iPad game (n = 92, prescribed 1 hour/day, 5 days/week or continued spectacle correction alone n = 90) in a multi-center randomized clinical trial. Prior to 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. RESULTS: 182 children with anisometropic (63\%), strabismic (16\%) (\<5[INCREMENT] 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 1.1 logMAR lines with binocular treatment and 0.6 logMAR lines with spectacles alone (adjusted difference = 0.5 lines; 95.1\% CI: 0.1 to 0.9). After 8 weeks, results (binocular treatment: mean amblyopic-eye VA improvement = 1.3 logMAR lines vs. 1.0 logMAR lines with spectacles alone, adjusted difference = 0.3 lines; 98.4\% CI: -0.2 to 0.8) were inconclusive because the confidence interval included both zero and the pre-defined difference in mean VA change of 0.75 logMAR lines. CONCLUSIONS: In 4- to 6-year-old children with amblyopia, binocular Dig Rush treatment resulted in greater improvement in amblyopic-eye VA over 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.}, issn = {1538-9235}, doi = {10.1097/OPX.0000000000001867}, author = {Manny, Ruth E and Holmes, Jonathan M and Kraker, Raymond T and Li, Zhuokai and Waters, Amy L and Kelly, Krista R and Kong, Lingkun and Crouch, Earl R and Lorenzana, Ingryd J and Alkharashi, Maan S and Galvin, Jennifer A and Rice, Melissa L and Melia, B Michele and Cotter, Susan A and Pediatric Eye Disease Investigator Group} }