NCT07222293 · Artelus AI
Assessment of AI Program 'DRISTi' as a Screening Tool
What this study is 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/reasons someone cannot join will be invited to participate and will consent to have ophthalmic images taken.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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
Where
- Oxford, North Carolina
- Raleigh, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 9, 2025 · Source of record for eligibility and locations