Effects of Artificial Intelligence-based Diabetic Retinopathy Screening on Timely Access to Treatment in Individuals With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 922
- 试验地点
- 1
- 主要终点
- Number of appropriate referrals to ophthalmologist
研究概览
简要总结
This is a clinical trial to evaluate the effects of universal screening for diabetic retinopathy (DR) and diabetic macular edema (DME) using artificial intelligence (AI) in the interpretation of fundus photographs obtained by trained nursing assistant using a portable fundus camera in a primary care setting, compared with images obtained by the same method, but interpreted by ophthalmologists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (> 18 years old) diagnosed with diabetes mellitus who agree to participate in the study.
排除标准
- •Any contraindication for pharmacological mydriasis (such as knowledge of having closed-angle glaucoma, pregnancy).
- •Life expectancy less than 6 months
研究组 & 干预措施
RDIA group
The proposed intervention is the provision of universal screening for DR with retinography performed on a mobile fundus camera under mydriasis supported by a computer program in adults with diabetes mellitus; based on the diagnosis made by the computer program, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification.
干预措施: Mobile retinography interpreted by artificial intelligence (Diagnostic Test)
RDOF group
The proposed control is the provision of universal screening for DR in adults with diabetes mellitus with retinography performed on a mobile fundus camera under mydriasis and with obtained images being interpreted remotely by ophthalmologists; based on the diagnosis made by the ophthalmologist, patients will be classified as having referable DR or not, and referral to a specialist will be based on this classification.
干预措施: Mobile retinography interpreted by ophthalmologists (Diagnostic Test)
结局指标
主要结局
Number of appropriate referrals to ophthalmologist
时间窗: Through study completion, an average of 1 year
Appropriate referrals: asymptomatic patients with moderate to severe nonproliferative DR, proliferative DR, significant macular edema, and uninterpretable exams. This data will be obtained by reviewing the medical records of ophthalmological in-person consults of included patients.
次要结局
- Number of patients referred for laser sessions(Through study completion, an average of 1 year)
- Number of pharmacological intraocular treatment(Through study completion, an average of 1 year)
- Referral failure(After study completion, an average of 15 months)