Luminopia One Amblyopia Vision Improvement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 43
- 主要终点
- Best-Corrected Visual Acuity of Fellow Eye
研究概览
简要总结
The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.
详细描述
The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4 to 7 years at the time of consent.
- •Amblyopia associated with anisometropia and/or mild strabismus.
- •Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
- •Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
- •Fellow eye BCVA 20/32 or better.
- •Interocular difference ≥ 3 logMAR lines.
- •Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.
排除标准
- •Atropine treatment in the past 2 weeks.
- •Prior amblyopia treatment (other than refractive correction) for > 12 months in total.
- •High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
- •History of low adherence with amblyopia treatment or light-induced seizures.
结局指标
主要结局
Best-Corrected Visual Acuity of Fellow Eye
时间窗: 12 weeks
Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Best-Corrected Visual Acuity of Amblyopic Eye
时间窗: 12 weeks
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
次要结局
- Stereoacuity(12 weeks)
- Adherence(12 weeks)
- Best-Corrected Visual Acuity of Amblyopic Eye(8 weeks)