A multinational randomized clinical trial of an eye-tracking-based binocular amblyopia treatment in children aged 4-9 years

This randomized controlled study compared efficacy and safety of a novel binocular, eye‐tracking‐based home amblyopia treatment (CureSight) to patching. Three cohorts (China, Israel, U.S.) enrolled 197 children aged 4 to < 9 years with anisometropic, small‐angle strabismic, or mixed‐mechanism amblyopia at 15 academic/community sites (modified intent‐to‐treat); 156 completed ≥ 60% of prescribed dosage (per‐protocol). CureSight: 90 min/day, 5 days/week for 16 weeks (120 h); patching: 2 h/day, 7 days/week (224 h). In the modified intent‐to‐treat dataset, visual acuity improvement from baseline to week 16 in the binocular group was noninferior to the patching group (0.028 logMAR; 95% CI ‐ 0.007 to 0.063). In the per‐protocol dataset, binocular treatment was superior to patching (0.04 logMAR; 95% CI 0.004 to 0.076). Improvement was significantly affected by baseline covariates of age, baseline vision levels, and previous amblyopia treatment. There was no significant between‐group difference in the magnitude of improvement in stereoacuity in either dataset. Overall, CureSight was noninferior to patching in these amblyopia types and yielded better visual outcomes in children completing ≥ 60% dosage, supporting binocular therapy as an additional first‐line option.