NCT04474041已完成不适用
A Clinical Study to Evaluate Visual Acuity Measured With the EyeQue Insight Versus an Eyechart in a Healthcare Office Environment.
EyeQue Corp.1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2020年7月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Acuity Visit 1
研究概览
简要总结
Open label exploratory study of the EyeQue Insight in healthy volunteers >=7 years of age.
详细描述
The primary objective of this study is to determine whether the EyeQue Insight (ETDRS visual acuity test) yields results similar to the standard ETDRS eyechart in the office.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Ages =>7 y.o.
- •Subjects that are minors (<18 years old) must have a parent or legal guardian.
- •Binocular vision
- •Willing and able to give informed consent and follow all study procedures and requirements
- •Fluent in English
排除标准
- •Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-
- •Has traveled outside the country within the last 4 weeks
- •Medications:
- •a. Taking medications that may affect ability to follow instructions.
- •Eye Disease:
- •a. Subjects with eye disease deemed by the Investigator to be inappropriate for the study such as an active eye infection.
- •Subjects that:
- •Lack physical dexterity to properly operate the EyeQue App on the smartphone
- •Lack the ability to follow instruction
- •Lack binocular vision
- •Lack the ability to maintain both eyes open
研究组 & 干预措施
Visual Acuity with a Hand-held Device Supported by Mobile App.
Experimental
The Insight will be compared to a standard ETDRS eyechart
干预措施: EyeQue Insight (Device)
结局指标
主要结局
Acuity Visit 1
时间窗: Visit 1: Day 0
Variance of best-corrected (BCVA) monocular VA of each participant's OD and OS measured on the ETDRS chart and the ETDRS test of the EyeQue Insight at Visit 1.
次要结局
- Acuity Visit 1 and 2(Visit 1 (Day 0) and Visit 2 (Day 7))
研究者
研究点 (1)
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