Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 531
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
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 fundus images using Artificial Intelligence (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.
- •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 Diabetic Retinopathy (DR) or Diabetic Macular Edema (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
研究组 & 干预措施
AEYE 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 Software Device (Device)
结局指标
主要结局
Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)
时间窗: 1 day
Sensitivity and specificity of the AEYE-DS device to detect mtmDR on digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on two macula-centered images (one image from each eye of the patient). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.
次要结局
- Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)(1 day)
- Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)(1 day)
- Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)(1 day)