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Published on: January 14, 2020
A multinational randomized clinical trial of an eye-tracking-based binocular amblyopia treatment in children aged 4-9
Oren Yehezkel1, Tamara Wygnanski-Jaffe2,3,4, Burton J Kushner5
1NovaSight Ltd., 7019900, Airport City, Israel.
Insights
A new binocular, eye-tracking treatment for amblyopia (CureSight) showed non-inferiority to patching in improving visual acuity. Children completing the full treatment course experienced superior visual outcomes with CureSight.
Area of Science:
- Ophthalmology
- Pediatric Eye Care
- Vision Science
Background:
- Amblyopia, or "lazy eye," affects visual development in children.
- Traditional amblyopia treatment, primarily patching, can have compliance challenges.
- Novel therapeutic approaches are needed to improve treatment adherence and outcomes.
Purpose of the Study:
- To compare the efficacy and safety of a novel binocular, eye-tracking-based home amblyopia treatment (CureSight) against traditional patching.
- To evaluate visual acuity and stereoacuity improvements in children with amblyopia.
- To assess the impact of treatment adherence on outcomes.
Main Methods:
- A randomized controlled trial involving 197 children aged 4-9 years with various amblyopia types across three countries.
- Participants were assigned to either CureSight (90 min/day, 5 days/week) or patching (2 h/day, 7 days/week) for 16 weeks.
- Outcomes were analyzed using modified intent-to-treat and per-protocol datasets, assessing visual acuity and stereoacuity.
Main Results:
- In the modified intent-to-treat analysis, CureSight was non-inferior to patching in visual acuity improvement (0.028 logMAR).
- The per-protocol analysis demonstrated CureSight's superiority over patching (0.04 logMAR), especially in children with higher adherence.
- No significant difference in stereoacuity improvement was observed between the two treatment groups.
Conclusions:
- Binocular, eye-tracking-based therapy (CureSight) is a viable, non-inferior alternative to patching for treating common childhood amblyopia.
- Higher treatment adherence with CureSight correlated with better visual outcomes, suggesting its potential as a first-line option.
- Further research may explore optimizing binocular therapy protocols for diverse amblyopia presentations.
Abstract:
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.