NCT04302012已完成不适用
Assessment of EyeArt Performance With Retinal Imaging Devices
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eyenuk, Inc.
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Agreement between multiple EyeArt operations
研究概览
简要总结
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using multiple retinal imaging devices and operators.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of diabetes mellitus;
- •Understanding of study and provision of written informed consent; and
- •22 years of age or older.
排除标准
- •Persistent visual impairment in one or both eyes;
- •History of macular edema, severe non-proliferative retinopathy, proliferative retinopathy, or retinal vascular (vein or artery) occlusion;
- •History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
- •Subject is contraindicated for fundus photography (for example, has light sensitivity);
- •Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
- •Subject is currently enrolled in an interventional study of an investigational device or drug; or
- •Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable dilated fundus photographs.
结局指标
主要结局
Agreement between multiple EyeArt operations
时间窗: 1 visit (1 day)
次要结局
未报告次要终点
研究者
研究点 (1)
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