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NCT07243665Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1040 (estimated)
First submitted
16 Nov 2025
Start date
17 Nov 2025
Primary completion date
Aug 2026
Lead sponsor
Singapore Eye Research Institute
NCT number
NCT07243665

What you commit to

  • Study type: Interventional
  • Planned participants: 1040
  • From 17 Nov 2025 to the primary completion date, Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Singapore National Eye Centre
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.