Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eyenuk, Inc.
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).
研究概览
简要总结
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older;
- •a diagnosis of diabetes mellitus; and
- •understanding of study and provision of written informed consent.
排除标准
- •Persistent visual impairment or sudden vision loss in one or both eyes;
- •History of uncorrected media opacity in one or both eyes;
- •History of retinal vascular disease other than diabetic eye disease;
- •History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract;
- •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/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 result in ungradable 4-wide field stereoscopic mydriatic fundus photographs.
结局指标
主要结局
Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).
时间窗: 1 visit
The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.
次要结局
未报告次要终点