Actively Recruiting
Assessment of AI Program 'DRISTi' as a Screening Tool
Led by Artelus AI · Updated on 2025-12-09
900
Participants Needed
2
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial 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/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
Official Title
Assessment of AI Program 'DRISTi' as a Screening Tool
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to sign and date the informed consent form
- Willingness to comply with all study procedures and availability for the duration of the study
- Age 21 years or older
- Diagnosed with diabetes mellitus based on criteria from WHO or ADA, including:
- Hemoglobin A1c (HbA1c) 6.5% or higher
- Fasting Plasma Glucose (FPG) 126 mg/dL or higher
- Symptoms of high blood sugar with random plasma glucose 200 mg/dL or higher
You will not qualify if you...
- 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 uncomplicated cataract surgery
- Contraindication for fundus photography, such as light sensitivity
- Contraindications for mydriatic medications or unwilling/unable to dilate
- Currently enrolled in an interventional study for the same condition
- Any condition or situation that may confound study results or interfere with participation
- Adults unable to consent due to impaired decision-making
- Individuals who are not adults (infants, children, teenagers)
- Pregnant women
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
New Century Ophthalmology - Oxford
Oxford, North Carolina, United States, 27565
Actively Recruiting
2
New Century Ophthalmology - Raleigh
Raleigh, North Carolina, United States, 27617
Actively Recruiting
Research Team
J
Jeanne Champion, Primary Site Coordinator Oxford
CONTACT
A
Adriana Valencia, Site Coordinator Raleigh
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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