NCT07222293 Assessment of AI Program 'DRISTi' as a Screening Tool
| NCT ID | NCT07222293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Artelus AI |
| Condition | Diabetic Retinopathy (DR) |
| Study Type | OBSERVATIONAL |
| Enrollment | 900 participants |
| Start Date | 2025-11-23 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 900 participants in total. It began in 2025-11-23 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Vinod Jindal, MD
PRINCIPAL INVESTIGATOR
New Century Ophthalmology
Frequently Asked Questions
Who can join the NCT07222293 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Diabetic Retinopathy (DR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07222293 currently recruiting?
Yes, NCT07222293 is actively recruiting participants. Contact the research team at Jeanne@ncophth.com for enrollment information.
Where is the NCT07222293 trial being conducted?
This trial is being conducted at Oxford, United States, Raleigh, United States.
Who is sponsoring the NCT07222293 clinical trial?
NCT07222293 is sponsored by Artelus AI. The principal investigator is Vinod Jindal, MD at New Century Ophthalmology. The trial plans to enroll 900 participants.