Control of Myopia Using Peripheral Diffusion Lenses: Efficacy and Safety Study Extension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Axial length
研究概览
简要总结
This is an open-label, controlled, multisite, two-arm parallel group clinical trial of 36-month duration to evaluate the continued safety and efficacy of SightGlass Vision Diffusion Optics Technology (DOT) Spectacles in reducing the progression of juvenile myopia.
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
- 6 Years 至 17 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 study (NCT03623074) and having not exited this study for more than 30 days;
- •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 3 years 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
CYPRESS Extension Test Arm
Single vision, impact resistant spectacle lenses; CYPRESS Test Arm 1 and CYPRESS Test Arm 2 will move into CYPRESS Extension Test Arm
干预措施: Novel spectacle lens design (Device)
CYPRESS Extension Control Arm
Single vision, impact resistant spectacle lenses; CYPRESS Control Arm remains in control lenses as the CYPRESS Extension Control Arm
干预措施: Spectacle lenses (Device)
结局指标
主要结局
Axial length
时间窗: 72 months
Test vs. control axial length change from baseline
Spherical equivalent refraction (SER)
时间窗: 72 months
Test vs. control spherical equivalent refraction (SER) change from baseline
次要结局
- SER(60 months)
- Axial length(42 months)