Testing an AI tool that reads eye photos for diabetic eye disease
Tests an AI program on eye photos of adults with diabetes.
Plain-language title generated from the registry record
Registry title: Assessment of AI Program 'DRISTi' as a Screening Tool
Key facts
- Where
- Oxford and Raleigh, United StatesSee the 2 sites
Where in United States
- New Century Ophthalmology - OxfordOxford, United StatesTaking people
- New Century Ophthalmology - RaleighRaleigh, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Artelus AI
- Trial code
- NCT07222293
- Record updated
- 9 December 2025
- Original description
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.Read full original descriptionShow less
Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
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.
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: 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; 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 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 is contraindicated for fundus photography (for example, has light sensitivity); 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.