NCT06884527进行中（未招募）不适用
Clinical Evaluation of A Innovative Spectacle Lens in Slowing Myopia Progression - A Cessation Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 91
- 试验地点
- 5
- 主要终点
- Change in cycloplegic spherical equivalent refraction from baseline
研究概览
简要总结
The purpose of this study is to quantify myopic progression following cessation of a innovative spectacle lenses after 3 years' use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Existing subjects from the NCT05174780 clinical study.
- •Ability to comply with study procedures.
- •Informed consent of parent/guardian and assent of subject.
排除标准
- •Current ocular infection, inflammation, or irritation likely to affect vision.
研究组 & 干预措施
(Previous Test Group) - Single Vision Spectacle Lens - Innovative Lens
Experimental
干预措施: Single Vision Lens to A innovative spectacle lens (Device)
(Previous Control Group) - Single Vision Spectacle Lens - Innovative Lens
Placebo Comparator
干预措施: Single Vision Lens to A innovative spectacle lens (Device)
结局指标
主要结局
Change in cycloplegic spherical equivalent refraction from baseline
时间窗: 0 - 12 months
Change in Axial Length from baseline
时间窗: 0 - 12 months
次要结局
未报告次要终点
研究者
研究点 (5)
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