Validation of the Artificial Intelligence Subsystem of the DDART Medical Device for the Automated Detection of Lesions Compatible With Diabetic Retinopathy in a Random Sample of Retinal Fundus Photographs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Validation the artificial intelligence subsystem of the DDART medical device for the automated detection of lesions compatible with diabetic retinopathy in a random sample of retinal fundus photographs.
研究概览
简要总结
To validate the artificial intelligence subsystem of the DDART medical device for the automated detection of lesions compatible with diabetic retinopathy in a random sample of retinal fundus photographs.
Secondary Objectives To determine the sensitivity and specificity of the artificial intelligence subsystem for the detection of diabetic retinopathy.
To estimate the overall diagnostic accuracy and the area under the receiver operating characteristic (ROC) curve (AUC).
To compare the performance of the algorithm with that of experienced ophthalmologists.
To evaluate the ability of the model to distinguish between different stages of disease severity
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Age ≥18 years Availability of a high-resolution color fundus photograph Confirmed diagnosis established by an ophthalmology specialist
排除标准
- •Poor-quality retinal images Concomitant ocular diseases that interfere with image interpretation
研究组 & 干预措施
Participants from outpatient clinics
干预措施: Color retinal fundus photograph (Diagnostic Test)
结局指标
主要结局
Validation the artificial intelligence subsystem of the DDART medical device for the automated detection of lesions compatible with diabetic retinopathy in a random sample of retinal fundus photographs.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Georgios Labiris
Democritus University of Thrace
Democritus University of Thrace