Clinical Efficacy of Implementing an AI-Driven Software as a Medical Device (SaMD) for Funduscopy Analysis in Patients With Diabetes Mellitus: A Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- VUNO Inc.
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- True Referral Rate
研究概览
简要总结
The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.
详细描述
The primary objective of this study is to compare the true referral rate between patients with VUNO Med®-Fundus AI™-assisted screening (intervention group) and those receiving usual clinical care without AI assistance (control group) among patients with diabetes mellitus.
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
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older.
- •A documented diagnosis of type 2 diabetes mellitus.
- •Ability to communicate adequately and provide written informed consent for participation in the study.
排除标准
- •A prior diagnosis of diabetic retinopathy at the time of screening.
- •A history of ophthalmic surgery within 6 months prior to the screening date.
- •A diagnosis of type 1 diabetes mellitus.
- •Pregnancy at the time of screening.
- •Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.
研究组 & 干预措施
Intervention group
For participants assigned to the intervention group, VUNO Med®-Fundus AI™ will be applied to the acquired fundus images, and the AI-generated outputs will be shown to clinicians during routine care.
干预措施: VUNO Med®-Fundus AI™ (Device)
Control group
For participants assigned to the control group, fundus images will be interpreted according to usual clinical care without AI assistance.
结局指标
主要结局
True Referral Rate
时间窗: within 6 months
The true referral rate is defined as the proportion of subjects who were diagnosed with diabetic retinopathy by an ophthalmologist among those referred to ophthalmology with suspected diabetic retinopathy. The true referral rate will be compared between the intervention and control groups.
次要结局
- Diabetic Retinopathy (DR) Diagnosis Rate(Within 6 months)
- Odds Ratio(Within 6 months)
- Referral Rate(Within 6 months)
- Time to Diabetic Retinopathy Diagnosis(Within 6 months)
- Performance of the AI System in Detecting Diabetic Retinopathy(Within 6 months)
- Accuracy of Referral for Diabetic Retinopathy(Within 6 months)
- Adherence Rate(Within 6 months)