Status:
RECRUITING
Assessment of AI Program 'DRISTi' as a Screening Tool
Lead Sponsor:
Artelus AI
Conditions:
Diabetic Retinopathy (DR)
Eligibility:
All Genders
21+ years
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 23 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT07222293
Start Date
November 23 2025
End Date
March 1 2026
Last Update
December 9 2025
Active Locations (2)
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1
New Century Ophthalmology - Oxford
Oxford, North Carolina, United States, 27565
2
New Century Ophthalmology - Raleigh
Raleigh, North Carolina, United States, 27617