NCT07758569招募中不适用
Validation of the Artificial Intelligence Subsystem of the DDART Medical Device for the Automated Detection of Lesions Compatible With Glaucoma in a Random Sample of Retinal Fundus Photograph
适应症
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 of the sensitivity and specificity of the artificial intelligence subsystem for AMD detection
研究概览
简要总结
Primary Objective
To validate the artificial intelligence subsystem of the DDART medical device for the automated detection of lesions compatible with glaucoma in a random sample of retinal fundus photographs.
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 a specialist.
排除标准
- •Poor-quality images. Coexisting ocular diseases that interfere with image interpretation.
结局指标
主要结局
Validation of the sensitivity and specificity of the artificial intelligence subsystem for AMD detection
时间窗: 1 year
Validation of the sensitivity and specificity of the artificial intelligence subsystem for diabetic retinopathy detection
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
研究点 (1)
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