临床试验/NCT07008001

NCT07008001招募中不适用

Clinical Assessment of DOT Spectacle Lenses in Chinese Children Extension

SightGlass Vision, Inc.5 个研究点分布在 1 个国家目标入组 175 人开始时间: 2025年8月1日最近更新: 2025年12月29日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: SightGlass Vision, Inc.
入组人数: 175
试验地点: 5
主要终点: Axial length Group II

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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

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

研究者

发起方

SightGlass Vision, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (5)

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