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

Study acronym: AIGS
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 29, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Nov 2025 to Nov 17, 2025
    • Study description expanded, about 261 words
    • Site details revised
    • Study title shortened, about 1 word
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07243665
Lead Sponsor Singapore Eye Research Institute
Collaborators: Singapore General Hospital, SingHealth Polyclinics
Conditions
(from sponsor)
Glaucoma
Related terms Glaucoma
Enrollment 1,040 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov