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

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, multicenter randomized controlled trial.

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]).

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 patching group improvement (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 (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).

CONCLUSIONS

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.