Recruiting

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

ClinicalTrials.gov IDNCT07243665

PhaseNA

Enrollment1040

SponsorSingapore Eye Research Institute

Age21 Years

SexALL

I'm interested View official listing

Conditions studied

Glaucoma

About this study

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.

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

Primary outcomes

Evaluation of model performance (At study completion (after all fundus images have been graded and data collection is finalized; approximately within 12 months of study initiation))

Eligibility information

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. \-

Study locations

Singapore National Eye Centre, Singapore, Singapore 168751 Singapore

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.