NCT04700111进行中（未招募）不适用
Lag of Accommodation With DOT Spectacle Lenses
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
- Best vision sphere
研究概览
简要总结
The objective of the study is to measure the difference in the lag of accommodation between DOT spectacle lenses and control spectacles.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Age 6-18 years of age, with a maximum of 6 of the first 25 completed participants being older than 14 years of age.
- •Is able to read (or be read to), understand and sign the assent document if under 17 years old or is able to read, understand and sign the consent document if aged 17 or 18 years.
- •Is under 17 years old and is accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document.
- •Should be emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D.
- •Is willing and able to follow instructions.
- •A person will be excluded from the study if he/she:
- •Is participating in any concurrent clinical or research study.
- •Have a history of myopia control treatment in the past year.
- •Has amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency.
- •Has any known active ocular disease and/or infection.
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism.
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops.
- •Has undergone strabismus surgery, refractive error surgery or intraocular surgery.
- •Is a child of a member of the study team.
排除标准
- 未提供
研究组 & 干预措施
Treatment 1 - DOT Pattern
Experimental
Spectacle lens or treatment 1
干预措施: DOT Pattern (Device)
Treatment 2 - Control Spectacles
Active Comparator
Comparator lens or control arm
干预措施: Control Spectacles (Device)
结局指标
主要结局
Best vision sphere
时间窗: 90 minutes
1\) Autorefractor spherical equivalent refraction measured at distance and at 40cm with each pair of treatment spectacles
次要结局
未报告次要终点
研究者
研究点 (1)
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