AI-assisted glaucoma screening in Singapore's diabetic eye program

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic, single-blind randomized controlled trial will recruit 1,040 adults with diabetes from two Singapore centers and randomize them 1:1 to AI-assisted fundus-photo grading or current manual grader assessment. After fundus imaging, both arms' results will be compared against a gold-standard glaucoma diagnosis determined by comprehensive ophthalmic examination including intraocular pressure, visual fields, optical coherence tomography, and dilated fundus assessment. Diagnostic accuracy, referral decisions, and downstream costs will be compared, and a cohort-based Markov model will estimate lifetime costs and cost-effectiveness. The trial is embedded within the Singapore Integrated Diabetic Retinopathy Programme to test the algorithm in a real-world screening pathway.

Why it matters

Who can join: the full rules

Inclusion Criteria: We aim to recruit all eligible patients who attend Singapore General Hospital (SGH) Diabetes \& Metabolism Centre's (DMC) clinics and SingHealth Polyclinics (SHP)-Bukit Merah under the Singapore Integrated Diabetic Retinopathy Programme (SiDRP). Patients are eligible for the study if

1. Aged 21 years old and above, with diabetes, including type 1 and type 2,
2. Retinal photos of the patients can be taken with the fundus camera in the clinics, regardless of photos' quality, and
3. They are willing and capable of providing a written informed consent form.

Exclusion Criteria: Patients meeting any of the exclusion criteria will be excluded from participation:

1. Patients who have difficulty in having retinal photos taken or have difficulties in completing the ocular examination protocols according to investigator's decision.
2. Any other contraindication(s) as indicated by the endocrinologists responsible for the patients.

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Where it's running

• Singapore National Eye Centre
  Singapore, Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Ching-Yu Cheng, MD, PhD — Singapore Eye Research Institute
• Study coordinator: Ching-Yu Cheng, MD, PhD
• Email: chingyu.cheng@duke-nus.edu.sg
• Phone: 65767277

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.