Binocular Home Treatment for Amblyopia: Gains Stable for One Year.

PubMed ID: 38360334

Author(s): Wygnanski-Jaffe T, Moshkovitz A, Kushner BJ, Belkin M, Yehezkel O; CureSight Pivotal Trial Group. Binocular Home Treatment for Amblyopia: Gains Stable for One Year. Am J Ophthalmol. 2024 Jun;262:199-205. doi: 10.1016/j.ajo.2024.02.004. Epub 2024 Feb 14. PMID 38360334

Journal: American Journal Of Ophthalmology, Volume 262, Jun 2024

PURPOSE To report the long-term outcomes of a noninferiority randomized controlled trial (RCT) with a binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd.) in patients with amblyopia.

DESIGN Prospective, multicenter, nonrandomized, long-term follow-up observational study of an RCT.

METHODS Forty-three children 4 to <9 years of age with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were initially treated for 16 weeks (NCT05185076) with CureSight. In this planned observational follow-up study, 38 patients with no additional amblyopia treatment were evaluated at 12 weeks post-treatment, and 27 were evaluated at 1-year post-treatment. The main outcome measures were visual acuity (VA), stereoacuity, and amblyopia recurrence at 12- and 52-week post-treatment.

RESULTS At 12-week post-treatment, improvement in amblyopic eye VA was maintained vs baseline (0.27 ± 0.14 logMAR, P .05). At 1 year there was a partial reduction in the amblyopic eye VA gain of 0.085±0.1 logMAR compared to end-of-treatment (P = .001), but the residual gain of 0.20±0.14 logMAR compared to baseline was statistically significant (P < .0001). Gains in stereoacuity and binocular VA were maintained vs baseline at both 12-weeks and 1-year post-treatment (P .05). Amblyopia recurrence (a worsening of ≥2 logMAR levels compared with end-of-treatment) occurred in 2/38 patients at 12-weeks post-treatment (5.3%), and in 5/27 patients at 1-year post-treatment (20.4%).

CONCLUSIONS VA and stereopsis gains following binocular treatment with CureSight were maintained at 1 year without additional treatment.