ChiCTR2500096375招募中Unknown
Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail
Departmental fund6 个研究点 分布在 1 个国家开始时间: 2024年10月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 试验地点
- 6
- 主要终点
- The effectiveness of the AI-assisted screening strategies, focusing on the detection rates of referable DR and DME.
研究概览
简要总结
To evaluate the effectiveness, cost-efficiency, and performance of an AI system in detecting VTDR and DME through FP and OCT in a screening unit.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 18 至 —(—)
- 性别
- All
入选标准
- •Individuals diagnosed with diabetes mellitus
- •Age 18 years or older
排除标准
- •Individuals with other ocular diseases that are sight-threatening and require urgent treatment, such as wet age-related macular degeneration, retinal detachment, vitreo-macular traction, foveoschisis, retinal vein occlusion, retinal artery occlusion
- •Individuals who refuse or are unable to provide informed consent
研究组 & 干预措施
Intervention Group 1 (AI-FP)
Intervention Group 2 ( AI-FP and AI-OCT)
Control Group (Standard Screening)
结局指标
主要结局
The effectiveness of the AI-assisted screening strategies, focusing on the detection rates of referable DR and DME.
次要结局
- The incremental cost-effectiveness ratios (ICERs)
研究者
研究点 (6)
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