Glaucoma Screening Using Artificial Intelligence Assisted Clinical Model in Singapore's Diabetic Eye Screening Program
Recruiting · NCT07243665 · Interventional (participants receive a specific treatment) · Lead sponsor: Singapore Eye Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
- 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.
Exclusion criteria
- Patients meeting any of the exclusion criteria will be excluded from participation:
- 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.
Where it is running
1 location listed.
- Singapore National Eye Centre - Singapore, Singapore, Singapore