DRISTi AI screening for diabetic retinopathy
Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
This will test whether the DRISTi artificial-intelligence software can correctly detect diabetic retinopathy from retinal photos in adults with diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Artelus AI Industry-sponsored |
| Locations | 2 sites (Oxford, North Carolina and 1 other locations) |
| Trial ID | NCT07222293 on ClinicalTrials.gov |
What this trial studies
Adults with diagnosed diabetes (age ≥21) will consent to have retinal (fundus) photographs taken at one of two clinic sites. The images will be analyzed by the DRISTi AI software and independently graded by an ophthalmic reading center. Results from the AI will be compared to the reference grading and statistical analysis will determine how accurately DRISTi identifies referable diabetic retinopathy, proliferative disease, and diabetic macular edema. The study is observational and involves no treatment changes—only image capture and diagnostic comparison.
Who should consider this trial
Good fit: Adults aged 21 or older with diagnosed diabetes who can undergo fundus photography and provide informed consent are ideal candidates.
Not a fit: People with persistent visual impairment, a history of macular edema or retinal vascular occlusion, recent retinal surgery or treatments, contraindications to fundus photography or dilation, or those under 21 are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, DRISTi could enable faster and more widely available retinal screening for people with diabetes, helping detect vision‑threatening disease earlier.
How similar studies have performed: Other AI-based retinal screening systems have demonstrated good diagnostic accuracy and some have received regulatory approval, so this approach builds on prior successful work.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Oxford, North Carolina and 1 other locations
- New Century Ophthalmology - Oxford — Oxford, North Carolina, United States (Recruiting)
- New Century Ophthalmology - Raleigh — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Vinod Jindal, MD — New Century Ophthalmology
- Study coordinator: Jeanne Champion, Primary Site Coordinator Oxford
- Email: Jeanne@ncophth.com
- Phone: 9192347003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.