Assessment of AI Program 'DRISTi' as a Screening Tool

Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy (DR)
• Intervention / Treatment: Diagnostic test: Fundus Image Grading

• Study Type: Observational
• Enrollment (Estimated): 900

Contacts and Locations

• Study Contact: Name: Jeanne Champion, Primary Site Coordinator Oxford; Phone Number: 9192347003; Email: Jeanne@ncophth.com
• Study Contact Backup: Name: Adriana Valencia, Site Coordinator Raleigh; Phone Number: 9192347406; Email: Adriana@ncophth.com

Study Locations

• United States
  • North Carolina
    • Oxford, North Carolina, United States, 27565
      • Recruiting
      • New Century Ophthalmology - Oxford
      • Contact: Jeanne Champion, Site Coordinator Oxford; Phone Number: 9192347003; Email: Jeanne@ncophth.com
      • Contact: Chaitan Walia, Study Coordinator, BA; Phone Number: 3129738490; Email: cpwalia7@gmail.com
      • Principal Investigator: Vinod Jindal, MD
    • Raleigh, North Carolina, United States, 27617
      • Recruiting
      • New Century Ophthalmology - Raleigh
      • Contact: Adriana Valencia, Site Coordinator Raleigh; Phone Number: 9192347406; Email: Adriana@ncophth.com
      • Contact: Chaitan Walia, Study Coordinator, BA; Phone Number: 3129738490; Email: cpwalia7@gmail.com
      • Principal Investigator: Vinod Jindal, MD
      • Sub-Investigator: Sumeet Jindal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Artelus AI
• Investigators: Principal Investigator: Vinod Jindal, MD, New Century Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 25, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Estimated): October 29, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Screening; Artificial Intelligence; AI; Diabetic Retinopathy; DR; Fundus Camera; Ophthalmic Device; Online/Offline
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Nutritional and Metabolic Diseases; Diabetic Retinopathy; Diabetes Mellitus
• Other Study ID Numbers: 25-02-199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: resource constraints

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No