CTRI/2017/11/010588已完成Unknown
A Study to assess the effectiveness of a Computer Automated Detection (CAD) programme in identifying the presence of diabetic retinopathy (DR) and diabetic macular edema (DME) in persons with diabetes
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- Google Inc
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The sensitivity and specificity of the software in detecting referable diabetic retinopathy and diabetic macula edema (moderate or worse DR and referable DME) as compared to trained human graders.
研究概览
简要总结
The study results demonstrate that an automated algorithm identified referable DR with performance equal to or exceeding the retinal specialists in a prospective clinical setting.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •An eligible patient must:(1) have a diagnosis of diabetes mellitus; (2) have no history of any other retinal vascular disease, glaucoma, or other disease that may affect the appearance of the retina or optic disc (refractive error and ocular surface disease are allowed); (3) other than cataract surgery, have no history of intraocular surgery, ocular laser treatments for any retinal disease, or ocular injections for diabetic macular edema or proliferative disease; (4) have no media opacity precluding good retinal photography; and (5) be of age 40 or older.
排除标准
- •Non-diabetic patients and other than the above said eligibility criteria.
结局指标
主要结局
The sensitivity and specificity of the software in detecting referable diabetic retinopathy and diabetic macula edema (moderate or worse DR and referable DME) as compared to trained human graders.
时间窗: 4-6 months
次要结局
- The sensitivity and specificity of the software in detecting severe or worse diabetic retinopathy and referable diabetic macula edema as compared to trained human graders.(4-6 months)
研究者
研究点 (1)
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