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An Eye-Tracking–Based Dichoptic Home Treatment for Amblyopia

2022; Elsevier BV; Volume: 130; Issue: 3 Linguagem: Inglês

10.1016/j.ophtha.2022.10.020

1549-4713

Tamara Wygnanski-Jaffe, Burton J. Kushner, Avital Moshkovitz, Michael Belkin, Oren Yehezkel, Ramat Gan, Abraham Spierer, Tamara Wygnanski-Jaffe, Nethanel Zitzer, Dan Cohen, Ahuva Shpigelman, Maoz Hadash, Ilya Ortenberg, Rinat Cohen, Hana Leib, Majd Arow, Reut Parness, Luba Rodov, Alexandra Goz, Haia Katz, Anabel Bazov, Christoph Nissen, Gabriel Avraham, Emad Borsha, Idit Keynann, Tali Aviv, Nathalie Corcos, Kaye Roll, Eedy Mezer, Vered Brucker, Michaël Abécassis, Ronen Rabinovich, Eran Laster, Ronit Politi, Hila Givoni, Ahed Amitirat, Claire L. Barrett, Adelina Zioni, Katty Kuperman, Yael Crocus,

Intraocular Surgery and Lenses

Comparing visual outcomes after use of a novel binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd) with patching.Prospective, multicenter, randomized, masked, controlled, noninferiority pivotal trial.One hundred three children 4 to < 9 years with anisometropic, small-angle strabismic or mixed-mechanism amblyopia were randomized 1:1 to either CureSight treatment or patching.The CureSight treatment uses combined anaglyph glasses and an eye tracker to induce real-time blur around the fellow eye fovea in dichoptic streamed video content. Participants used the device for 90 minutes/day, 5 days/week for 16 weeks (120 hours). The patching group received 2 hours of patching 7 days/week (224 hours). The prespecified noninferiority margin was 1 line.The primary outcome was the improvement in the amblyopic eye visual acuity (VA), modeled with a repeated measures analysis of covariance. Secondary outcomes included stereoacuity, binocular VA, and treatment adherence rates, analyzed by a 1-sample Wilcoxon test within each group and a 2-sample Wilcoxon test comparing groups. Safety outcomes included the frequency and severity of study-related adverse events (AEs).CureSight group VA improvement was found to be noninferior to patching group improvement (0.28 ± 0.13 logarithm of the minimum angle of resolution [logMAR] [P < 0.0001] and 0.23 ± 0.14 logMAR [P < 0.0001], respectively; 90% confidence interval [CI] of difference, -0.008 to 0.076). Stereoacuity improvement of 0.40 log arcseconds (P < 0.0001) and improved binocular VA (0.13 logMAR; P < 0.0001) were observed in the binocular treatment group, with similar improvements in the patching group in stereoacuity (0.40 log arcseconds; P < 0.0001) and binocular VA (0.09 logMAR; P < 0.0001), with no significant difference between improvements in the 2 groups in either stereoacuity (difference, 0; 95% CI, -0.27 to -0.27; P = 0.76) or binocular VA (difference, 0.041; 95% CI, -0.002 to 0.085; P = 0.07). The binocular treatment group had a significantly higher adherence than the patching group (91% vs. 83%; 95% CI, -4.0% to 21%; P = 0.011). No serious AEs were found.Binocular treatment was well tolerated and noninferior to patching in amblyopic children 4 to < 9 years of age. High adherence may provide an alternative treatment option for amblyopia.Proprietary or commercial disclosure may be found after the references.