CTRI/2018/05/013726进行中（未招募）Unknown
ARDA (Automated Detection Algorithm) assisted read study protocol - Vision Center related study
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- Google Inc
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- This programme could be used to screen for diabetic eye disease in peripheral centres
研究概览
简要总结
| The purpose is the clinical validation of the ARDA software, which automates the detection of diabetic retinopathy from retinal fundus images. |
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Recruitment of patients from the Vision Centers which use Tele-ophthalmologists for grading the fundus photo images.
- •An eligible patient must have a diagnosis of diabetes mellitus.
排除标准
- •Non-diabetic patients.
结局指标
主要结局
This programme could be used to screen for diabetic eye disease in peripheral centres
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 referrable diabetic macular edema as compared to trained human graders (4-6 months)(4-6 months)
研究者
研究点 (1)
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