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【ChiCTR2500096375】Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail
ChiCTR2500096375
正在进行
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2025-01-22
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Diabetic retinal disease
Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail
Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail
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.
随机平行对照
诊断试验新技术
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.
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.
Departmental fund
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354
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2024-10-01
2025-02-28
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1) Individuals diagnosed with diabetes mellitus 2) Age 18 years or older；
登录查看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；
登录查看Binh Dinh Eye Hospital
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Binh Dinh Eye Hospital的其他临床试验
Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong的其他临床试验
- 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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