NCT05893979进行中（未招募）不适用
Myopia Control Spectacle Lens Use 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
- 90
- 试验地点
- 16
- 主要终点
- Cycloplegic Spherical Equivalent Refraction (cSER)
研究概览
简要总结
To quantify myopic progression (cycloplegic spherical equivalent refraction - cSER) following the cessation of use of specific spectacle lenses.
To quantify axial length progression following cessation of use of specific spectacle lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously a successfully completed participant in the CYPRESS Extension study;
- •Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
- •Willingness to participate in the trial for up to 12 months without contact lens wear;
- •The subject's parent(s) or legal guardian(s) must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
排除标准
- •Known allergy to proparacaine, tetracaine, or tropicamide.
研究组 & 干预措施
Test Lens Group
Active Comparator
干预措施: Spectacle Lenses (Device)
Control Lens Group
Active Comparator
干预措施: Spectacle Lenses (Device)
结局指标
主要结局
Cycloplegic Spherical Equivalent Refraction (cSER)
时间窗: 12 months
Change in cSER
次要结局
- Axial Length (AL)(12 months)
- Cycloplegic Spherical Equivalent Refraction (cSER)(6 months)
研究者
研究点 (16)
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