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Assessment of AI Program 'DRISTi' as a Screening Tool
NCT07222293 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DIAGNOSTIC_TEST Fundus Image Grading
Study Locations (2)
North Carolina
- New Century Ophthalmology - Oxford — Oxford
- New Century Ophthalmology - Raleigh — Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2025-11-23 |
| Est. Completion | 2026-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07222293
The ClinicalTrials.gov registry entry for NCT07222293 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Artelus AI, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Retinopathy (DR) appearing as the primary indexed condition, and to 1 intervention — of which Fundus Image Grading is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07222293 reports 2 study locations spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07222293 about?
NCT07222293 is a clinical study titled "Assessment of AI Program 'DRISTi' as a Screening Tool". 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 ...
What is the current status of trial NCT07222293?
This trial is currently recruiting. The enrollment target is 900 participants. The study started on 2025-11-23. Estimated completion is 2026-03.
What conditions does trial NCT07222293 study?
This clinical trial studies the following conditions: Diabetic Retinopathy (DR). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07222293?
The interventions under investigation include: Fundus Image Grading (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07222293?
This trial is sponsored by Artelus AI, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07222293 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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