跳至主要内容
临床试验/ChiCTR2500096375
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

发起方
Departmental fund

研究点 (6)

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