NCT07222293Recruiting
Assessment of AI Program 'DRISTi' as a Screening Tool
Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 900 (estimated)
- First submitted
- 25 Oct 2025
- Start date
- 23 Nov 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Artelus AI
- Diseases
- Diabetic eye disease
- NCT number
- NCT07222293
What you commit to
- Study type: Observational
- Planned participants: 900
- From 23 Nov 2025 to the primary completion date, Mar 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 21 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New Century Ophthalmology - Oxford Coordinator of this site? Confirm its status | Oxford | United States | Recruiting |
| New Century Ophthalmology - Raleigh Coordinator of this site? Confirm its status | Raleigh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.