A Blinded, Self-control Trial to Evaluate an Artificial Intelligence Based CAD System for Diabetic Retinography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,081
- 试验地点
- 1
- 主要终点
- Se and Sp under investigation target 3
研究概览
简要总结
To evaluate the safety and performance of an innovative artificial intelligence based Computer-Aided Diagnosis(CAD) system for diabetic retinography, Retinal images of patients with diabetes mellitus or diabetic retinopathy(DR) were collected retrospectively. All images were graded by a retinal specialists expert panel and the CAD device using the International Clinical Diabetic Retinopathy severity scale criteria. Investigator responsible for DR grading by CAD system is blinded to the DR grading results from the expert panel. Finally, DR grading results of the CAD system and experts were compared using sensitivity and specificity.
详细描述
- Retinal images were collected retrospectively according to the following inclusion/exclusion criterion:
Inclusion Criterion:
Clinical history of diabetes mellitus or diabetic retinopathy; Fully Gradable Images; around 45° field which covers optic disc and macula; complete patient identification information;
Exclusion Criterion:
incomplete patient identification information; 2. DR grading by expert panel At first, retinal images are graded by three experts independently, then they met for a consensus meeting to discuss cases without initial agreement. If they can't achieve consensus, a final decision is made by the principal investigator. Experts give a grading of both DR and Diabetic Macular Edema (DME) for each image according to the International Clinical Diabetic Retinopathy severity scale criteria and hard exudates around optic disc. 3. Blinding and DR grading by CAD system Before DR grading by CAD system, a randomized identification(ID) is assigned to each retinal image, which ensures that investigator responsible for CAD system operation is masked to the expert panel grading result. Both DR and DME grading is generated by the CAD system and the results are exported. 4. Unblinding Finally, all data are unblinded and results of the CAD system are compared to the results of human grading, which is considered the gold standard, using measures as sensitivity and specificity;
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
Investigator responsible for CAD system operation is masked to the expert panel grading result.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of diabetes mellitus or diabetic retinopathy;
- •Fully Gradable Images;
- •around 45° field which covers optic disc and macula;
- •complete patient identification information;
排除标准
- •incomplete patient identification information
结局指标
主要结局
Se and Sp under investigation target 3
时间窗: through study completion，an average of four months
1.investigation target 3: Negative: DR grading of 0 or 1; Positive: DR grading of 2 or higher; After completion of DR grading by expert panel and CAD system, results of the CAD system were compared to the results of human grading, which is considered the gold standard, using measures as sensitivity(Se) and specificity(Sp).
次要结局
- Se and Sp under investigation target 1/2/4/5(through study completion，an average of four months)
研究者
Youxin Chen
Professor
Peking Union Medical College Hospital