NCT04160988已完成不适用
A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus
Acer Being Health Inc.1 个研究点 分布在 1 个国家目标入组 703 人开始时间: 2019年12月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 703
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
This study is to evaluate the clinical performance of VeriSee DR for DR screening from color fundus photography images in patients with diabetes mellitus. The sensitivity and specificity of VeriSee DR's automated image analysis for screening the diabetes retinopathy will be determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects enrolled in this study should meet all the following criteria.
- •Subject with age ≥ 20 years old
- •Subject with documented diagnosis of diabetes mellitus
- •Subject with image taken by color fundus photography that meet the following requirement:
- •The resolution of image is 1024×1024 pixels or higher;
- •The angle view of image is 45 or 50 degree.
- •Subject's image includes macula and optic nerve as judged by the ophthalmologist.
排除标准
- •Subjects will be excluded if they meet any of the following criteria.
- •The color fundus photography image previously used by VeriSee DR during the development process and pre-clinical test
- •The macula, optic nerve, or other part in the image of color fundus photography is unclear to determine the disease condition as judged by the ophthalmologist.
结局指标
主要结局
Sensitivity
时间窗: 2 months
To evaluate the clinical performance of VeriSee DR by determining the sensitivity. Sensitivity = 100% x TP/(TP+FN)
Specificity
时间窗: 2 months
To evaluate the clinical performance of VeriSee DR by determining the specificity. Specificity = 100% x TN/(TN+FP)
次要结局
- Negative Predictive Values (NPV)(2 months)
- Percentage of Participant Images With Insufficient Quality as Judged by VeriSee DR(2 months)
- Positive Predictive Values (PPV)(2 months)
研究者
研究点 (1)
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