NCT03119675已完成不适用
Prospective Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Gobiquity Mobile Health0 个研究点目标入组 358 人开始时间: 2016年11月1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
- 358
- 主要终点
- Sensitivity and specificity of amblyopia risk factors detected by photo refraction
研究概览
简要总结
Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs)
Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™ App and patients are evaluated with cycloplegic refraction.
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
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 months to 6 years inclusive.
- •Informed consent given by parent or legal guardian.
排除标准
- •History of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement
研究组 & 干预措施
Photorefraction of ages 1 to 6 years
Other
Clinical Validation of GoCheck Kids Smartphone App
干预措施: GoCheck Kids (iOS) (Device)
Photorefraction of ages 1 to 6 years
Other
Clinical Validation of GoCheck Kids Smartphone App
干预措施: GoCheck Kids (Windows) (Device)
结局指标
主要结局
Sensitivity and specificity of amblyopia risk factors detected by photo refraction
时间窗: 1 Day
Identification of risk factors as compared to gold standard cycloplegic refraction
次要结局
- Number of patients with gaze error identified by photo screening(1 day)
研究者
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