DRISTi AI screening for diabetic retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with diagnosed diabetes (age ≥21) will consent to have retinal (fundus) photographs taken at one of two clinic sites. The images will be analyzed by the DRISTi AI software and independently graded by an ophthalmic reading center. Results from the AI will be compared to the reference grading and statistical analysis will determine how accurately DRISTi identifies referable diabetic retinopathy, proliferative disease, and diabetic macular edema. The study is observational and involves no treatment changes—only image capture and diagnostic comparison.

Why it matters

Who can join: the full rules

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

Where it's running

• New Century Ophthalmology - Oxford
  Oxford, North Carolina, United States Recruiting
• New Century Ophthalmology - Raleigh
  Raleigh, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Vinod Jindal, MD — New Century Ophthalmology
• Study coordinator: Jeanne Champion, Primary Site Coordinator Oxford
• Email: Jeanne@ncophth.com
• Phone: 9192347003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Automated AI system to detect diabetic retinopathy in adults with diabetes

  A AI-based software device is being tested to automatically detect diabetic retinopathy from retinal images in adults with diabetes.

  Recruiting Digital Diagnostics, Inc. · Jacksonville, Florida · NCT07844317

• N-acetylcysteine for diabetic retinopathy in adults with type 2 diabetes

  This study tests whether taking N-acetylcysteine for three months can help people with type 2 diabetes who have mild to moderate diabetic retinopathy.

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• Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease

  This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.

  Recruiting Osijek University Hospital · Osijek · NCT07520045

• Finding protein biomarkers for AMD, diabetic retinopathy, and retinal detachment

  This project will test whether proteins found in blood and eye fluids can help diagnose or predict outcomes for adults with AMD, diabetic retinopathy, or retinal detachment.

  Recruiting Fondazione G.B. Bietti, IRCCS · Roma, Italy · NCT07500324

• Diabetic retinopathy prevalence and risk factors at a Da Nang hospital

  We will find how common different stages of diabetic retinopathy are and which clinical or lab factors are linked to it among adults with diabetes treated at a Da Nang hospital.

  Recruiting Da Nang Family General Hospital · Da Nang · NCT07468058

• AI-assisted retinal photo screening for adults with diabetes

  This will test whether adding the VUNO Med®-Fundus AI tool to routine retinal photo screening helps adults with type 2 diabetes get more accurate referrals for diabetic retinopathy.

  Recruiting VUNO Inc. · Incheon, Gyeonggi-do · NCT07378956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.