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Recruiting Observational

Assessment of AI Program 'DRISTi' as a Screening Tool

NCT07222293 · tracked via the Priya Life Science USA tracker
Sponsor
Artelus AI
Phase
Observational
Started
2025-11-23
Last updated
2025-12-09

Condition(s) studied

Diabetic Retinopathy (DR)

Investigational drug(s) / intervention(s)

Fundus Image Grading

Fundus Image Grading: The image is graded by a fully automated AI device

Study 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

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Ability to sign and date the informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Age (≥)21 years of age or older 4. Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA) 1. Hemoglobin A1c (HbA1c) ≥ 6.5% 2. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) 3. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L) Exclusion Criteria: 1. Persistent visual impairment in one or both eyes; 2. History of macular edema or retinal vascular (vein or artery) occlusion; 3. History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications; 4. Subject is contraindicated for fundus photography (for example, has light sensitivity); 5. Subject has contraindications for mydriatic medications or is unwilling or unable to dilate; 6. Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or 7. 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 8. 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

Primary outcome measure(s)

  • Accuracy of AI Grade — From time of arrival to completion of diagnostic tests, up to 8 hours
    AI generated image grades are directly compared to a Human generated image grade

Trial sites (2)

FacilityCityRegionStatus
New Century Ophthalmology - Oxford Oxford North Carolina Recruiting
New Century Ophthalmology - Raleigh Raleigh North Carolina Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07222293 on ClinicalTrials.gov ↗ ← All trials in the USA