Assessment of AI Program 'DRISTi' as a Screening Tool

NCT07222293 | Recruiting FDA Device

• 1 other identifier: 25-02-199
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Retinopathy (DR)

Keywords

Artificial Intelligence; Ophthalmic Device; AI; Diabetic Retinopathy; Diabetes; DR; Screening; Online/Offline; Fundus Camera

Outcome Measures

Primary Outcomes (1)

• Accuracy of AI Grade

  AI generated image grades are directly compared to a Human generated image grade

  From time of arrival to completion of diagnostic tests, up to 8 hours

Interventions

Fundus Image Grading DIAGNOSTIC_TEST

The image is graded by a fully automated AI device

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be referred from primary care clinics and ophthalmology clinics in North Carolina.

You may qualify if:

• 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)

You may not qualify if:

• 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 is contraindicated for fundus photography (for example, has light sensitivity);
• 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
• 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 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

Sponsors & Collaborators

• Artelus AI: lead

Study Sites (2)

New Century Ophthalmology - Oxford

Oxford, North Carolina, 27565, United States

RECRUITING

New Century Ophthalmology - Raleigh

Raleigh, North Carolina, 27617, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Vinod Jindal, MD

  New Century Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanne Champion, Primary Site Coordinator Oxford

CONTACT

9192347003; Jeanne@ncophth.com

Adriana Valencia, Site Coordinator Raleigh

CONTACT

9192347406; Adriana@ncophth.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2025
• First Posted: October 29, 2025
• Study Start: November 23, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)