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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096375
Enrollment
Unknown
Registered
2025-01-22
Start date
2024-12-10
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic retinal disease

Interventions

Intervention Group 1 (AI-FP):Participants will undergo fundus photography. The AI-FP will analyze the FPs to detect referable DR and suspected DME. Referral decisions will be based on the AI-FP findin
Intervention Group 2 ( AI-FP and AI-OCT):Participants will undergo fundus photography and OCT imaging. The same AI-FP system used in Intervention Group 1 will analyze the FPs to detect referable DR an
Control Group (Standard Screening):DR screening using FPs without AI assistance.

Sponsors

Binh Dinh Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Individuals diagnosed with diabetes mellitus 2) Age 18 years or older

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The effectiveness of the AI-assisted screening strategies, focusing on the detection rates of referable DR and DME.;

Secondary

MeasureTime frame
The incremental cost-effectiveness ratios (ICERs) ;

Countries

Vietnam

Contacts

Public ContactDr CHEUNG Yim Lui Carol/Dr NGUYEN Thanh Triet

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

carolcheung@cuhk.edu.hk+852 3943 5831

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026