NCT04693260已完成不适用
A Clinical Study to Evaluate the Remote Monitoring of Myopia Patients With the EyeQue Insight
EyeQue Corp.2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年7月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Departure from scheduled follow-up visits with clinical confirmation
研究概览
简要总结
The objective of this study is to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.
详细描述
A prospective exploratory study to determine whether the remote monitoring of myopia patients with the EyeQue Insight (visual acuity test) can replace regularly scheduled follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Be treated for myopia with Ortho-K, day contacts, or night contacts
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, keratoconus, etc.
- •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
- •Had eye surgery within the last 12 months (including Lasik)
结局指标
主要结局
Departure from scheduled follow-up visits with clinical confirmation
时间窗: Approximately 21 Weeks
Site will monitor the patient remotely and determine if the subject should depart from their scheduled visits based on at-home testing. If visit departure is warranted the site will examine them in the office and confirm if a departure from normally schedule visit was warranted.
次要结局
- Measure rapidly changing visual acuity(Approximately 21 Weeks)
研究者
研究点 (2)
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