NCT05562622进行中（未招募）不适用
Clinical Assessment of DOT Spectacle Lenses in Chinese Children
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
- 195
- 试验地点
- 5
- 主要终点
- Axial length
研究概览
简要总结
This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of 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.
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 6-13 years of age
- •SER error between -0.75D and -5.00D
- •Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear
排除标准
- •Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K)
- •Astigmatism worse than -1.50 DC (by manifest refraction) in either eye
- •Anisometropia (SER manifest refraction) greater than 1.00 D
研究组 & 干预措施
Test Arm 2
Other
Single vision, impact-resistant spectacle lenses
干预措施: Spectacle lenses (Device)
SightGlass Vision Test Arm 1
Experimental
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
时间窗: 12 months
Change in axial length from baseline
次要结局
- Axial length(24 months)
- Axial length(36 months)
研究者
研究点 (5)
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