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<p>This randomized controlled study compared efficacy and safety of a novel binocular, eye-tracking–based home amblyopia treatment (CureSight) to patching. Three cohorts (China, Israel, U.S.) enrolled 197 children aged 4 to &lt; 9&#xa0;years with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia at 15 academic/community sites (modified intent-to-treat); 156 completed ≥ 60% of prescribed dosage (per-protocol). CureSight: 90&#xa0;min/day, 5&#xa0;days/week for 16&#xa0;weeks (120&#xa0;h); patching: 2&#xa0;h/day, 7&#xa0;days/week (224&#xa0;h). In the modified intent-to-treat dataset, visual acuity improvement from baseline to week 16 in the binocular group was noninferior to the patching group (0.028 logMAR; 95% CI − 0.007 to 0.063). In the per-protocol dataset, binocular treatment was superior to patching (0.04 logMAR; 95% CI 0.004 to 0.076). Improvement was significantly affected by baseline covariates of age, baseline vision levels, and previous amblyopia treatment. There was no significant between-group difference in the magnitude of improvement in stereoacuity in either dataset. Overall, CureSight was noninferior to patching in these amblyopia types and yielded better visual outcomes in children completing ≥ 60% dosage, supporting binocular therapy as an additional first-line option.</p>

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A multinational randomized clinical trial of an eye-tracking-based binocular amblyopia treatment in children aged 4–9 years

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月9日

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  • Oren Yehezkel,
  • Tamara Wygnanski-Jaffe,
  • Burton J. Kushner,
  • Michael Belkin,
  • Liu Hong,
  • Bu Juan,
  • Avital Moshkovitz,
  • Wei Zhang,
  • Rui Liu,
  • 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 Bazov,
  • Chaim 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 Corcos,
  • Rui Hao,
  • Shu Wang,
  • Minshu Wang

摘要

This randomized controlled study compared efficacy and safety of a novel binocular, eye-tracking–based home amblyopia treatment (CureSight) to patching. Three cohorts (China, Israel, U.S.) enrolled 197 children aged 4 to < 9 years with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia at 15 academic/community sites (modified intent-to-treat); 156 completed ≥ 60% of prescribed dosage (per-protocol). CureSight: 90 min/day, 5 days/week for 16 weeks (120 h); patching: 2 h/day, 7 days/week (224 h). In the modified intent-to-treat dataset, visual acuity improvement from baseline to week 16 in the binocular group was noninferior to the patching group (0.028 logMAR; 95% CI − 0.007 to 0.063). In the per-protocol dataset, binocular treatment was superior to patching (0.04 logMAR; 95% CI 0.004 to 0.076). Improvement was significantly affected by baseline covariates of age, baseline vision levels, and previous amblyopia treatment. There was no significant between-group difference in the magnitude of improvement in stereoacuity in either dataset. Overall, CureSight was noninferior to patching in these amblyopia types and yielded better visual outcomes in children completing ≥ 60% dosage, supporting binocular therapy as an additional first-line option.