PMID- 36306974 OWN - NLM STAT- MEDLINE DCOM- 20230227 LR - 20230227 IS - 1549-4713 (Electronic) IS - 0161-6420 (Linking) VI - 130 IP - 3 DP - 2023 Mar TI - An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial. PG - 274-285 LID - S0161-6420(22)00835-1 [pii] LID - 10.1016/j.ophtha.2022.10.020 [doi] AB - 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. CI - Copyright (c) 2022 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. FAU - Wygnanski-Jaffe, Tamara AU - Wygnanski-Jaffe T AD - Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel; Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. FAU - Kushner, Burton J AU - Kushner BJ AD - Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin. FAU - Moshkovitz, Avital AU - Moshkovitz A AD - NovaSight, Ltd, Airport City, Israel. FAU - Belkin, Michael AU - Belkin M AD - Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel; Goldschleger Eye Research Institute, Sheba Medical Center, Tel Hashomer, Israel. FAU - Yehezkel, Oren AU - Yehezkel O AD - NovaSight, Ltd, Airport City, Israel. Electronic address: oren.yehezkel@gmail.com. CN - CureSight Pivotal Trial Group LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20221026 PL - United States TA - Ophthalmology JT - Ophthalmology JID - 7802443 SB - IM MH - Child MH - Humans MH - *Amblyopia/therapy MH - Prospective Studies MH - Eye-Tracking Technology MH - Treatment Outcome MH - Follow-Up Studies MH - Vision, Binocular MH - *Video Games MH - Sensory Deprivation OTO - NOTNLM OT - Amblyopia OT - Binocular treatment OT - Dichoptic treatment OT - Eye tracking OT - Stereopsis FIR - Gan, Ramat IR - Gan R FIR - Spierer, Abraham IR - Spierer A FIR - Wygnanski-Jaffe, Tamara IR - Wygnanski-Jaffe T FIR - Zitzer, Nethanel IR - Zitzer N FIR - Cohen, Dan IR - Cohen D FIR - Shpigelman, Ahuva IR - Shpigelman A FIR - Hadash, Maoz IR - Hadash M FIR - Ortenberg, Ilya IR - Ortenberg I FIR - Cohen, Rinat IR - Cohen R FIR - Leib, Hana IR - Leib H FIR - Arow, Majd IR - Arow M FIR - Parness, Reut IR - Parness R FIR - Rodov, Luba IR - Rodov L FIR - Goz, Alexandra IR - Goz A FIR - Katz, Haia IR - Katz H FIR - Bazov, Anabel IR - Bazov A FIR - Nissen, Chaim IR - Nissen C FIR - Avraham, Gabriel IR - Avraham G FIR - Borsha, Emad IR - Borsha E FIR - Keynann, Idit IR - Keynann I FIR - Aviv, Tali IR - Aviv T FIR - Corcos, Nathalie IR - Corcos N FIR - Roll, Keren IR - Roll K FIR - Mezer, Eedy IR - Mezer E FIR - Brucker, Vered IR - Brucker V FIR - Abecassis, Meital IR - Abecassis M FIR - Rabinovich, Ronen IR - Rabinovich R FIR - Laster, Eran IR - Laster E FIR - Politi, Ronit IR - Politi R FIR - Givoni, Hila IR - Givoni H FIR - Amitirat, Ahed IR - Amitirat A FIR - Barrett, Chiya Robert IR - Barrett CR FIR - Zioni, Adelina IR - Zioni A FIR - Kuperman, Katty IR - Kuperman K FIR - Crocus, Yael IR - Crocus Y EDAT- 2022/10/29 06:00 MHDA- 2023/03/03 06:00 CRDT- 2022/10/28 19:25 PHST- 2022/07/12 00:00 [received] PHST- 2022/10/18 00:00 [revised] PHST- 2022/10/18 00:00 [accepted] PHST- 2022/10/29 06:00 [pubmed] PHST- 2023/03/03 06:00 [medline] PHST- 2022/10/28 19:25 [entrez] AID - S0161-6420(22)00835-1 [pii] AID - 10.1016/j.ophtha.2022.10.020 [doi] PST - ppublish SO - Ophthalmology. 2023 Mar;130(3):274-285. doi: 10.1016/j.ophtha.2022.10.020. Epub 2022 Oct 26.