RecruitingNCT07222293

Assessment of AI Program 'DRISTi' as a Screening Tool

Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations

Sponsor

Artelus AI

Enrollment

900 participants

Start Date

Nov 23, 2025

Study Type

OBSERVATIONAL

Conditions

Diabetic Retinopathy (DR)

Summary

A study will be conducted to demonstrate that DRISTi will correctly diagnose Diabetic Retinopathy (e.g., mtmDR, PDR, DME) in eyes of patients with diabetes. Participants who have been diagnosed with diabetes mellitus and meet the other inclusion/exclusion criteria will be invited to participate and will consent to have ophthalmic images taken. These images will be analyzed by DRISTi AI software and evaluated by an ophthalmic reading center. The results will be compared, and a statistical analysis will be completed to ensure statistical significance in the outcomes thus proving DRISTi is an effective DR diagnosis tool.

Eligibility

Min Age: 21 Years

Inclusion Criteria7

Ability to sign and date the informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Age (≥)21 years of age or older
Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA)
Hemoglobin A1c (HbA1c) ≥ 6.5%
Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)

Exclusion Criteria12

Persistent visual impairment in one or both eyes;
History of macular edema or retinal vascular (vein or artery) occlusion;
History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
Subject is contraindicated for fundus photography (for example, has light sensitivity);
Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or
Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs
Subject falls into one of the below categories:
Adults unable to consent (individuals w/ impaired decision-making capacity)
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners