NCT05857943已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 363
- 试验地点
- 6
- 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.
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
研究者
研究点 (6)
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