A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years of Age


Manny RE, Holmes JM, Kraker RT, Li Z, Waters AL, Kelly KR, Kong L, Crouch ER, Lorenzana IJ, Alkharashi MS, Galvin JA, Rice ML, Melia MB, Cotter SA, Cotter SA. A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years of Age. Optom Vis Sci 2022;

Date Published:

2022 Jan 24


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.

Last updated on 02/01/2022