Actively Recruiting
Assessment of DRISTi as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
Led by Artelus AI · Updated on 2025-12-09
900
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the DRISTi automated screening tool to diagnose Diabetic Retinopathy (including mtmDR, PDR, and DME) in patients with diabetes. The study invites adults diagnosed with diabetes mellitus to participate by having eye images taken. These images will be analyzed by the DRISTi AI software and an ophthalmic reading center to compare results and complete statistical analysis for validation. Participants will have ophthalmic images taken and graded by the fully automated DRISTi AI device. The study is observational and involves no study drug or treatment. The primary outcome measure is the accuracy of the AI grading, assessed from arrival to completion of diagnostic tests within a maximum of 8 hours. There is no randomization or placebo group. During the study, participants will consent and comply with study procedures including imaging and data collection. Researchers will evaluate the AI's diagnostic accuracy compared to the ophthalmic reading center's evaluation. Participants may be monitored for any safety concerns related to imaging procedures. The study allows for the inclusion of adults aged 21 years or older diagnosed with diabetes mellitus, and participation duration varies by individual.
CONDITIONS
Brief 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 study duration
- Age 21 years or older
- Diagnosed with diabetes mellitus as defined by WHO or ADA criteria (HbA1c 6.5%, fasting plasma glucose 126 mg/dL, or symptoms with random plasma glucose 200 mg/dL)
You will not qualify if you...
- Persistent visual impairment in one or both eyes
- History of macular edema or retinal vascular occlusion
- History of ocular injections, laser retinal treatment, or intraocular surgery other than uncomplicated cataract surgery
- Contraindications for fundus photography (e.g., light sensitivity)
- Contraindications or unwillingness to dilate with mydriatic medications
- Current enrollment in an interventional study for the same condition
- Conditions or situations that may confound results or interfere with participation
- Adults unable to consent, individuals under 21 years old, pregnant women, prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 hours
Participants undergo fundus photography which is graded by a fully automated AI device to assess diabetic retinopathy.
1 visit (in-person)
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
A
Adriana Valencia, Site Coordinator Raleigh
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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