Treating Amblyopia With CureSight
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
Patients with visual acuity and ocular characteristics outside the Novasight FDA multi-center study are to perform the same Curesight procedures- including M&S EVA or eETDRS patched acuity, stereo and then utilize the Curesight device 1.5 hours per day, 6 days per week over 3-6 months to determine treatment efficacy.
An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial T. Wygnanski-Jaffe, B. J. Kushner, A. Moshkovitz, M. Belkin, O. Yehezkel and G. CureSight Pivotal Trial Ophthalmology 2023 Vol. 130 Issue 3 Pages 274-285
详细描述
Patients with visual acuity worse than 20/30 due to amblyopia will be offered therapy with Curesight. The Curesight-component of amblyopia therapy will be offered no-charge for up to 4 months. The Curesight device must then be returned to Alaska Blind Child Discovery.
The Curesight device will be administered in a similar, safe manner as the previous multi-centered trial that was performed in Israel and the US.
Patient Selection Inclusion criteria: patients aged 3 to less than 19 years. Amblyopia may be due to refractive error, strabismus and/or deprivation.
Exclusion criteria: Inability to participate with any form of monocular visual acuity testing and stereopsis testing. Light-induced seizures. Lack of any internet at home. Pregnancy.
Recruitment: Patients will be recruited from within Alaska Children's EYE & Strabismus clinical practice. Patients will not be paid for recruitment. Patients will have opportunity to review the publication regarding the study1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •amblyopia
排除标准
- •lack of brain and eye capacity for improved vision lack of home WiFi
结局指标
主要结局
Visual acuity
时间窗: 2-6 months
Amblyopic eye best corrected visual acuity
次要结局
- stereopsis(2-6 months)