NCT05617794进行中（未招募）不适用
Effect of Diffusion Optics Technology (DOT) Spectacle Lenses on Choroidal Thickness and Choroidal Vascularity Index in Emmetropes
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
- 30
- 试验地点
- 1
- 主要终点
- Retinal and Choroidal Thickness
研究概览
简要总结
The objective of the study is to measure the effect of Diffusion Optics Technology (DOT) spectacle lenses on the choroidal thickness and choroidal vascularity index compared to control lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are 8-14 years of age;
- •Are able to read (or be read to), understand and sign the assent document;
- •Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
- •Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;
- •Are willing and able to follow instructions.
排除标准
- •Are participating in any concurrent interventional clinical or research study;
- •Have a history of myopia control treatment in the past year;
- •Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
- •Have any known active ocular disease and/or infection;
- •Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;
- •Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops;
- •Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
- •Are a child of a member of the study team.
研究组 & 干预措施
Treatment 1 - Diffusion Optics Technology (DOT) Pattern
Experimental
干预措施: Diffusion Optics Technology (DOT) Pattern Spectacle Lens (Device)
Treatment 2 - Control Spectacles
Active Comparator
干预措施: Control Spectacle Lens (Device)
结局指标
主要结局
Retinal and Choroidal Thickness
时间窗: 30 minutes and 60 minutes
Change from Baseline, 30 minutes and 60 minutes
Choroidal Thickness
时间窗: 30 minutes and 60 minutes
Change from Baseline, 30 minutes and 60 minutes
次要结局
- Software Method Comparison(30 minutes and 60 minutes)
研究者
研究点 (1)
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