TY - JOUR
T1 - High-Adherence Dichoptic Treatment Versus Patching in Anisometropic and Small Angle Strabismus Amblyopia
T2 - A Randomized Controlled Trial
AU - the CureSight Pivotal Trial Group
AU - Wygnanski-Jaffe, Tamara
AU - Kushner, Burton J.
AU - Moshkovitz, Avital
AU - Belkin, Michael
AU - Yehezkel, Oren
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2025/1
Y1 - 2025/1
N2 - Purpose: To compare the effectiveness and safety of a novel binocular eye-tracking-based-home-treatment (CureSight) to patching for the treatment of amblyopia. Design: Prospective, masked, multicenter randomized controlled trial. Methods: One hundred forty-nine children 4 to < 9 years with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were randomized to either binocular dichoptic treatment (n=75) or patching (n=74). The binocular dichoptic treatment group used the CureSight system for 90 min/day, 5 days/week for 16 weeks (120 hours). The patching group received 2-hour patching 7 days/week (224 hours). The primary outcome was the mean improvement from baseline in amblyopic eye visual acuity (VA) to week 16 in both study groups (non-inferiority of ≤0.10 logarithm of the minimum angle of resolution [logMAR]). Results: In the modified intent-to-treat (mITT) group, the mean improvement from baseline at week 16 in the binocular treatment group was noninferior to patching group improvement (0.034 logMAR [95% CI -0.009 to 0.076]). In the per-protocol (PP) dataset, the mean improvement from baseline at week 16 in the binocular treatment group was superior to patching group improvement (0.05 logMAR ([95% CI; 0.007 to 0.097]). There was no significant between-group difference in the magnitude of improvement in stereoacuity in the mITT and the PP datasets. Median adherence in the mITT binocular treatment group (94.0%) was also significantly higher than in the patching group (83.9%; p=0.0038). Conclusions: A binocular, eye-tracking-based amblyopia home treatment is noninferior to, and produced better visual outcomes than, patching in children with anisometropic, small angle strabismus and mixed mechanism amblyopia.
AB - Purpose: To compare the effectiveness and safety of a novel binocular eye-tracking-based-home-treatment (CureSight) to patching for the treatment of amblyopia. Design: Prospective, masked, multicenter randomized controlled trial. Methods: One hundred forty-nine children 4 to < 9 years with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were randomized to either binocular dichoptic treatment (n=75) or patching (n=74). The binocular dichoptic treatment group used the CureSight system for 90 min/day, 5 days/week for 16 weeks (120 hours). The patching group received 2-hour patching 7 days/week (224 hours). The primary outcome was the mean improvement from baseline in amblyopic eye visual acuity (VA) to week 16 in both study groups (non-inferiority of ≤0.10 logarithm of the minimum angle of resolution [logMAR]). Results: In the modified intent-to-treat (mITT) group, the mean improvement from baseline at week 16 in the binocular treatment group was noninferior to patching group improvement (0.034 logMAR [95% CI -0.009 to 0.076]). In the per-protocol (PP) dataset, the mean improvement from baseline at week 16 in the binocular treatment group was superior to patching group improvement (0.05 logMAR ([95% CI; 0.007 to 0.097]). There was no significant between-group difference in the magnitude of improvement in stereoacuity in the mITT and the PP datasets. Median adherence in the mITT binocular treatment group (94.0%) was also significantly higher than in the patching group (83.9%; p=0.0038). Conclusions: A binocular, eye-tracking-based amblyopia home treatment is noninferior to, and produced better visual outcomes than, patching in children with anisometropic, small angle strabismus and mixed mechanism amblyopia.
UR - http://www.scopus.com/inward/record.url?scp=85205299199&partnerID=8YFLogxK
U2 - 10.1016/j.ajo.2024.08.011
DO - 10.1016/j.ajo.2024.08.011
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C2 - 39179129
AN - SCOPUS:85205299199
SN - 0002-9394
VL - 269
SP - 293
EP - 302
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
ER -