【ChiCTR2500096375】Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail

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基本信息

登记号

ChiCTR2500096375

试验状态

正在进行

药物名称

人工智能系统

药物类型

规范名称

首次公示信息日的期

2025-01-22

临床申请受理号

靶点

适应症

Diabetic retinal disease

试验通俗题目

Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail

试验专业题目

Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail

申办单位信息

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

诊断试验新技术

随机化

A statistician independent of the study team will generate a computer-based random allocation sequence, stratified by age and visual acuity to ensure balanced allocation across the groups.

盲法

The research assistant will send the participant's stratification information, including age group and VA category, to the study coordinator. The study coordinator will then assign the participant to one of the three groups according to the randomization schedule and notify the research assistant of the group assignment. The study coordinator will manage the flow of information to ensure appropriate allocation of imaging resources. For participants in Intervention Groups 1 and 2, AI-generated reports from both the AI-FP and AI-OCT systems will be provided to the clinicians before making triage decisions. In the Control Group, clinicians will make decisions based solely on their interpretation of the FPs without AI assistance.

试验项目经费来源

Departmental fund

试验范围

目标入组人数

354

实际入组人数

第一例入组时间

2024-10-01

试验终止时间

2025-02-28

是否属于一致性

入选标准

1) Individuals diagnosed with diabetes mellitus 2) Age 18 years or older；

排除标准

1) 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 2) Individuals who refuse or are unable to provide informed consent；

研究者信息

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试验机构

Binh Dinh Eye Hospital

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