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

Tamara Wygnanski-Jaffe, Burton J. Kushner, Avital Moshkovitz, Michael Belkin, Oren Yehezkel, Ramat Gan, Abraham Spierer, 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 BazovChaim Nissen, Gabriel Avraham, Emad Borsha, Idit Keynann, Tali Aviv, Nathalie Corcos, Keren Roll, Eedy Mezer, Vered Brucker, Meital Abecassis, Ronen Rabinovich, Eran Laster, Ronit Politi, Hila Givoni, Ahed Amitirat, Chiya Robert Barrett, Adelina Zioni, Katty Kuperman, Yael Crocus

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

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
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2022 American Academy of Ophthalmology

Funding

The authors thank Gregg T. Lueder for serving as the safety officer for the study and Lisa Deutsch, PhD, and Netanel Deutsch, MA, the study biostatisticians (Biostats Statistical Consulting, Ltd, Maccabim, Israel). Supported by NovaSight Ltd., Airport City, Israel. The sponsor or funding organization participated in designing the study; conducting it; data management; data analysis; interpreting the data; and preparation, review, and approval of the manuscript.

FundersFunder number
Netanel Deutsch
NovaSight Ltd.

    Keywords

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

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