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.