Autonomous AI for Diabetic Retinopathy Screening in Youth (AI-DR): A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Number of Participants Who Get Screened With a Diabetic Eye Exam
研究概览
简要总结
The purpose of this study is to determine if providing in clinic point-of-care autonomous AI diabetic retinopathy exams improves screening rates compared to standard of care referral to an eye care provider, in a randomized control trial in a racially and ethnically diverse cohort of youth.
详细描述
This study will recruit 164 individuals ages 8-21 with type 1 and type 2 diabetes. Participants will be randomized to usual care (referral to an eye care provider for a dilated eye exam) or the intervention arm and undergo a point-of-care diabetic eye exam using autonomous AI software on a non-mydriatic fundus camera. Participants in the intervention group will receive the diabetic eye exam results immediately from the autonomous AI system, and if abnormal will be referred to an eye care provider for a dilated eye exam. Participants in the standard of care group will have 6 months to complete the diabetic eye exam.
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
- None
盲法说明
Participants are masked to the study arms until after randomization
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets American Diabetes Association (ADA) criteria for diabetic retinopathy screening:
- •Diagnosis of Type 1 diabetes for ≥3 years, and age 11 or in puberty
- •Diagnosis of Type 2 diabetes
排除标准
- •Diabetic eye exam within the last 6 months
- •Known diabetic retinopathy
研究组 & 干预措施
Usual care with educational reinforcement
Standard of care referral to Eye Care Provider (ECP) for the diabetic eye exam with educational reinforcement
Diabetic Retinopathy Exam
Point of care (POC) Diabetic Retinopathy Exam using Autonomous AI on non-mydriatic fundus camera
干预措施: Point of Care Autonomous AI diabetic retinopathy exam (Diagnostic Test)
结局指标
主要结局
Number of Participants Who Get Screened With a Diabetic Eye Exam
时间窗: 6 months
The number of participants who get screened with a diabetic eye exam will be assessed for the AI group and the standard of care group referral to an eye care provider (ECP).
次要结局
- Follow-up Rates With an Eye Care Provider(6 months)