NCT05650190进行中（未招募）不适用
Spectacle Lenses Visual Acuity Assessments 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
- 51
- 试验地点
- 11
- 主要终点
- Visual Acuity
研究概览
简要总结
This is a two-arm parallel group, non-dispensing study. Participants will be existing active CYPRESS Extension (CPRO-1802-002) subjects. Subjects will undergo additional visual performance assessments.
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
- None
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Existing subject from the CYPRESS Extension study (CPRO-1802-002)
- •Ability to comply with study assessments
- •The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed coy of the form
排除标准
- •Any current ocular infection, inflammation or irritation likely to affect vision
研究组 & 干预措施
Test Arm
Experimental
Single vision, impact resistant spectacle lenses; Test Arm
干预措施: Novel spectacle lens design (Device)
Control Arm
Placebo Comparator
Single vision, impact resistant spectacle lenses; Control Arm
干预措施: Spectacle lenses (Device)
结局指标
主要结局
Visual Acuity
时间窗: 15 minutes
Reading Speed (maximum words per minute)
次要结局
- Near Visual Acuity with Glare(15 minutes)
研究者
研究点 (11)
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