Assessment of AI Program 'DRISTi' as a Screening Tool
ConditionDiabetic Retinopathy (DR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorArtelus AI
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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);
Trial population
Patients will be referred from primary care clinics and ophthalmology clinics in North Carolina.
Trial design
Design model
Case-only
Time perspective
Cross-sectional
Treatments tested in this trial
Fundus Image Grading
Diagnostic testThe image is graded by a fully automated AI device
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Accuracy of AI Grade
AI generated image grades are directly compared to a Human generated image grade
Time frame
From time of arrival to completion of diagnostic tests, up to 8 hours Source ClinicalTrials.gov