Assessment of AI Program 'DRISTi' as a Screening Tool

Artelus AI

Status: Enrolling

Conditions: Diabetic Retinopathy (DR)

Treatments: Diagnostic Test: Fundus Image Grading

Study type: Observational

Funder types: Industry

Identifiers

NCT07222293

25-02-199

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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