Goldschleger Eye Institute, Sheba Medical Center (T.W.-J.), Tel Hashomer, Israel; Sackler Faculty of Medicine, Tel-Aviv University (T.W.-J., M.B.), Tel-Aviv, Israel.
NovaSight Ltd. (A.M., O.Y.), Airport City, Israel.
Am J Ophthalmol. 2024 Jun;262:199-205. doi: 10.1016/j.ajo.2024.02.004. Epub 2024 Feb 14.
To report the long-term outcomes of a noninferiority randomized controlled trial (RCT) with a binocular eye-tracking-based home treatment (CureSight; NovaSight, Ltd.) in patients with amblyopia.
Prospective, multicenter, nonrandomized, long-term follow-up observational study of an RCT.
Forty-three children 4 to <9 years of age with anisometropic, small-angle strabismic, or mixed-mechanism amblyopia were initially treated for 16 weeks (NCT05185076) with CureSight. In this planned observational follow-up study, 38 patients with no additional amblyopia treatment were evaluated at 12 weeks post-treatment, and 27 were evaluated at 1-year post-treatment. The main outcome measures were visual acuity (VA), stereoacuity, and amblyopia recurrence at 12- and 52-week post-treatment.
At 12-week post-treatment, improvement in amblyopic eye VA was maintained vs baseline (0.27 ± 0.14 logMAR, P< .0001), with no change vs the end-of-treatment visit (P > .05). At 1 year there was a partial reduction in the amblyopic eye VA gain of 0.085±0.1 logMAR compared to end-of-treatment (P = .001), but the residual gain of 0.20±0.14 logMAR compared to baseline was statistically significant (P < .0001). Gains in stereoacuity and binocular VA were maintained vs baseline at both 12-weeks and 1-year post-treatment (P < .0001), with no change vs end-of-treatment (P > .05). Amblyopia recurrence (a worsening of ≥2 logMAR levels compared with end-of-treatment) occurred in 2/38 patients at 12-weeks post-treatment (5.3%), and in 5/27 patients at 1-year post-treatment (20.4%).
VA and stereopsis gains following binocular treatment with CureSight were maintained at 1 year without additional treatment.
报告一项非劣效随机对照试验（RCT）的长期结果，该试验采用基于双眼眼动追踪的家庭治疗（CureSight；NovaSight，Ltd.）治疗弱视患者。
对 RCT 的前瞻性、多中心、非随机、长期随访观察研究。
43 名 4 至<9 岁的屈光不正性、小角度斜视性或混合机制弱视儿童，最初接受 CureSight 治疗 16 周（NCT05185076）。在这项计划中的观察性随访研究中，38 名无额外弱视治疗的患者在治疗后 12 周进行评估，27 名患者在治疗后 1 年进行评估。主要观察指标为治疗后 12 周和 52 周时的视力（VA）、立体视锐度和弱视复发情况。
治疗后 12 周时，弱视眼 VA 较基线改善（0.27±0.14 logMAR，P<.0001），与治疗结束时相比无变化（P >.05）。1 年后，与治疗结束时相比，弱视眼 VA 增益部分减少 0.085±0.1 logMAR（P =.001），但与基线相比，仍有 0.20±0.14 logMAR 的残余增益具有统计学意义（P <.0001）。治疗后 12 周和 1 年时，立体视锐度和双眼 VA 的增益均较基线保持不变（P <.0001），与治疗结束时相比无变化（P >.05）。治疗后 12 周时，2/38 例（5.3%）患者发生弱视复发（与治疗结束时相比，VA 恶化≥2 logMAR 水平），治疗后 1 年时，5/27 例（20.4%）患者发生弱视复发。
在不进行额外治疗的情况下，使用 CureSight 进行双眼治疗后的 VA 和立体视锐度增益可在 1 年内保持。
