NCT07243665 Glaucoma Screening Using Artificial Intelligence Assisted Clinical Model in Singapore's Diabetic Eye Screening Program
| NCT ID | NCT07243665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Singapore Eye Research Institute |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,040 participants |
| Start Date | 2025-11-17 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,040 participants in total. It began in 2025-11-17 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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. \-
Contact & Investigator
Ching-Yu Cheng, MD, PhD
PRINCIPAL INVESTIGATOR
Singapore Eye Research Institute
Frequently Asked Questions
Who can join the NCT07243665 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07243665 currently recruiting?
Yes, NCT07243665 is actively recruiting participants. Contact the research team at chingyu.cheng@duke-nus.edu.sg for enrollment information.
Where is the NCT07243665 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07243665 clinical trial?
NCT07243665 is sponsored by Singapore Eye Research Institute. The principal investigator is Ching-Yu Cheng, MD, PhD at Singapore Eye Research Institute. The trial plans to enroll 1,040 participants.