High-Adherence Dichoptic Treatment Versus Patching in Anisometropic and Small Angle Strabismus Amblyopia: A Randomized Controlled Trial

center dot PURPOSE: To compare the effectiveness and safety of a novel binocular eye-tracking-based-home-treatment (CureSight) to patching for the treatment of amblyopia. center dot DESIGN: Prospective, masked, multicenter randomized controlled trial. center dot METHODS: One hundred forty-nine children 4 to < 9 years with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were randomized to either binocular dichoptic treatment (n = 75) or patching (n = 74). The binocular dichoptic treatment group used the CureSight system for 90 min/day, 5 days/week for 16 weeks (120 hours). The patching group received 2-hour patching 7 days/week (224 hours). The primary outcome was the mean improvement from baseline in amblyopic eye visual acuity (VA) to week 16 in both study groups (non-inferiority of <= 0.10 logarithm of the minimum angle of resolution [logMAR]). center dot RESULTS: In the modified intent-to-treat (mITT) group, the mean improvement from baseline at week 16 in the binocular treatment group was noninferior to patchto 0.076]). In the per-protocol (PP) dataset, the mean improvement from baseline at week 16 in the binocular treatment group was superior to patching group improvement (0.05 logMAR ([95% CI; 0.007 to 0.097]). There was no significant between-group difference in the magnitude of improvement in stereoacuity in the mITT and the PP datasets. Median adherence in the mITT binocular treatment group (94.0%) was also significantly higher than in the patching group (83.9%; p = 0.0038). better visual outcomes than, patching in children with center dot Conclusions:<bold> </bold>A binocular, eye-tracking-based amblyopia home treatment is noninferior to, and produced better visual outcomes than, patching in children with anisometropic, small angle strabismus and mixed mechanism amblyopia. (Am J Ophthalmol 2025;269: 293- 302. (c) 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC license (http://creativecommons.org/licenses/by-nc/4.0/ ))