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RECRUITING
NCT07243665
NA

Glaucoma Screening Using Artificial Intelligence Assisted Clinical Model in Singapore's Diabetic Eye Screening Program

Sponsor: Singapore Eye Research Institute

View on ClinicalTrials.gov

Summary

Glaucoma is major cause of irreversible blindness and is characterized by optic nerve damage and visual field loss. Screening for glaucoma is challenging due to lack of a simple, accurate, cost-efficient and standardized process. Artificial intelligence, (AI) especially deep learning (DL) algorithms have potential to automate glaucoma detection, but have to be evaluated in real world settings, before public deployment. This study aims to evaluate the screening accuracy of a DL algorithm for glaucoma detection using colour fundus photographs (CFP) in a pragmatic randomised control trial (RCT). The algorithm will be tested in 1040 eligible patients with diabetes, recruited from the Diabetes \& Metabolism Centre's clinics under the Singapore Integrated Diabetic Retinopathy Program (SiDRP) and randomized to 2 arms: AI-assisted model vs current standard of care (grader assessment). The performance of both arms will be compared to performance of study ophthalmologist in diagnosing glaucoma. We hypothesize that the DL model has better screening performance in detecting glaucoma in the community, compared to the current practice method.

Official title: A Pragmatic Randomized Controlled Trial of a New Artificial Intelligence-Assisted Clinical Model in Opportunistic Screening for Glaucoma in the Singapore Integrated Diabetic Retinopathy Program

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1040

Start Date

2025-11-17

Completion Date

2027-03

Last Updated

2026-01-29

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Artificial Intelligence model to detect glaucoma

A Vision Transformer model to detect glaucoma from fundus photos

OTHER

No intervention

Control group with current practice model by human graders

Locations (1)

Singapore National Eye Centre

Singapore, Singapore, Singapore