Prospective Clinical Trial to Demonstrate the Efficacy and Safety if AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Funduscopic Images Obtained With a Funduscopic Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 3
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital funduscopic images using AI-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO):
- •Understand the study and volunteer to sign the informed consent
排除标准
- •Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
- •Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
- •Previously diagnosed with Diabetic Retinopathy.
- •History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
- •Currently participating in another investigational eye study and actively receiving investigational product for DR or DME.
- •Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).
- •Participant is contraindicated for imaging by fundus imaging systems used in the study:
- •Participant is hypersensitive to light
- •Participant recently underwent photodynamic therapy (PDT)
- •Participant is taking medication that causes photosensitivity
- •Participant has a history of angle-closure glaucoma or narrow anterior chamber angles
- •Subject is pregnant.
研究组 & 干预措施
AEYE-DS Software Device
An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy
干预措施: AEYE-DS Software (Device)
结局指标
主要结局
Sensitivity and Specificity
时间窗: 1 year
次要结局
未报告次要终点