Wygnanski-Jaffe Tamara, Kushner Burton J, Moshkovitz Avital, Belkin Michael, Yehezkel Oren
Sheba Medical Center (T.W.J., C.P.T.G., M.B.), Goldschleger Eye Institute, Tel Hashomer, Israel; Faculty of Medicine (T.W.J., M.B.), Tel- Aviv University, Tel-Aviv, Israel.
Department of Ophthalmology and Visual Sciences (B.J.K.), University of Wisconsin, Madison, WI, USA.
Am J Ophthalmol. 2025 Jan;269:293-302. doi: 10.1016/j.ajo.2024.08.011. Epub 2024 Aug 22.
To compare the effectiveness and safety of a novel binocular eye-tracking-based-home-treatment (CureSight) to patching for the treatment of amblyopia.
Prospective, masked, multicenter randomized controlled trial.
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]).
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).
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.
比较一种基于双眼眼动追踪的新型家庭治疗方法（CureSight）与遮盖疗法治疗弱视的有效性和安全性。
前瞻性、盲法、多中心随机对照试验。
149名4至<9岁的屈光参差性、小角度斜视性或混合机制性弱视儿童被随机分为双眼分视治疗组（n = 75）或遮盖治疗组（n = 74）。双眼分视治疗组每天使用CureSight系统90分钟，每周5天，共16周（120小时）。遮盖治疗组每周7天接受2小时遮盖（224小时）。主要结局是两个研究组中弱视眼视力（VA）从基线到第16周的平均改善情况（最小分辨角对数[logMAR]≤0.10的非劣效性）。
在改良意向性分析（mITT）组中，双眼治疗组在第16周时从基线的平均改善情况不劣于遮盖治疗组（0.034 logMAR [95% CI -0.009至0.076]）。在符合方案（PP）数据集中，双眼治疗组在第16周时从基线的平均改善情况优于遮盖治疗组（0.05 logMAR [95% CI；0.007至0.097]）。在mITT和PP数据集中，立体视锐度改善幅度的组间差异无统计学意义。mITT双眼治疗组的中位依从性（94.0%）也显著高于遮盖治疗组（83.9%；p = 0.0038）。
对于屈光参差性、小角度斜视和混合机制性弱视儿童，基于双眼眼动追踪的弱视家庭治疗不劣于遮盖疗法，且视觉效果更好。
