High-adherence dichoptic treatment versus patching in anisometropic and small angle strabismus amblyopia: a randomized controlled trial.

PubMed ID: 39179129

Author(s): Wygnanski-Jaffe T, Kushner BJ, Moshkovitz A, Belkin M, Yehezkel O; CureSight Pivotal Trial Group. High-adherence dichoptic treatment versus patching in anisometropic and small angle strabismus amblyopia: a randomized controlled trial. Am J Ophthalmol. 2024 Aug 21:S0002-9394(24)00374-X. doi: 10.1016/j.ajo.2024.08.011. Online ahead of print. PMID 39179129

Journal: American Journal Of Ophthalmology, Aug 2024

PURPOSE To compare the effectiveness and safety of a novel binocular eye-tracking-based-home-treatment (CureSight) to patching for the treatment of amblyopia.

DESIGN Prospective, masked, randomized controlled noninferiority trial.

SETTING Multicenter, multinational, home treatment.

PARTICIPANTS One hundred forty-nine children 4 to < 9 years with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were randomized to either binocular treatment (n=75) or patching (n=74).

INTERVENTIONS The binocular 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).

MAIN OUTCOME MEASURES 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]). Other outcomes included changes in stereoacuity and binocular VA from baseline to week 16.

RESULTS The mean improvement from baseline at week 16 in the binocular treatment group was noninferior to patching group improvement in the modified intent-to-treat (mITT) dataset (LS mean difference between groups in improvement from baseline: 0.034 logMAR (95% CI -0.009 to 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 (LS mean difference between groups in improvement from baseline: 0.05 logMAR ([95% CI; 0.007 to 0.097]). At week 16, both groups showed significant median improvement in stereoacuity, with no significant between-group difference in the magnitude of improvement in both the mITT and the PP datasets. Binocular VA was also improved in both groups (p<0.0001). Median adherence in the mITT binocular treatment group (94.0%) was also significantly higher than in the patching group (83.9%; p=0.0038).

CONCLUSIONS Binocular, eye-tracking-based amblyopia home treatment is at least as effective as patching.

Copyright © 2024. Published by Elsevier Inc.