Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 5
- 主要终点
- Axial length Group II
研究概览
简要总结
This is a randomized, controlled, open-label, evaluator-blinded, multicenter, clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.
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)
盲法说明
Evaluator/Investigational site staff tasked with measuring key primary variables (i.e., axial length and SER) will be masked to participant's former treatment group.
入排标准
- 年龄范围
- 8 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 CATHAY study (NCT05562622)
- •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 12 months without contact lens wear or any other myopia management intervention
- •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
- •1. Known allergy to proparacaine, tetracaine, or tropicamide or cyclopentolate
研究组 & 干预措施
SightGlass Vision Test Arm Groups I (formerly test group)
Single vision, impact-resistant spectacle lenses
干预措施: Novel spectacle lens design (Device)
SightGlass Vision Test Arm Groups II (formerly control group)
Single vision, impact-resistant spectacle lenses
干预措施: Novel spectacle lens design (Device)
结局指标
主要结局
Axial length Group II
时间窗: 12 months
Change in axial length from baseline to 12 months
Axial length Group I
时间窗: 12 months
Change in axial length from baseline to 36 months
次要结局
未报告次要终点