An Eye-Tracking–Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial

the CureSight Pivotal Trial Group

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: Comparing visual outcomes after use of a novel binocular eye-tracking–based home treatment (CureSight; NovaSight, Ltd) with patching. Design: Prospective, multicenter, randomized, masked, controlled, noninferiority pivotal trial. Participants: 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. Methods: 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. Main Outcome Measures: 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). Results: 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. Conclusions: 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. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

Original languageEnglish
Pages (from-to)274-285
Number of pages12
JournalOphthalmology
Volume130
Issue number3
DOIs
StatePublished - Mar 2023

Funding

FundersFunder number
Netanel Deutsch
NovaSight Ltd.

    Keywords

    • Amblyopia
    • Binocular treatment
    • Dichoptic treatment
    • Eye tracking
    • Stereopsis

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