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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form form. Who Should NOT Join This Trial: 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. \- Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. \-

Treatments Being Tested

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

Locations (1)

Singapore National Eye Centre
Singapore, Singapore, Singapore