Diabetic Retinopathy (DR)NCT07222293
Assessment of AI Program 'DRISTi' as a Screening Tool
An observational study of Diabetic Retinopathy (DR), run by Artelus AI at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy (DR)
- What is being tested?
- Fundus Image Grading
- How many people
- 900 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Nov 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be referred from primary care clinics and ophthalmology clinics in North Carolina.
Who may be able to join
- 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)
- Hemoglobin A1c (HbA1c) ≥ 6.5%
- Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
- Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
Who cannot join
- 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);
- Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
- Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or
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- 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
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
New Century Ophthalmology - Oxford
Oxford, North Carolina, 27565
Jeanne Champion, Site Coordinator Oxford, 9192347003, Jeanne@ncophth.com
Chaitan Walia, Study Coordinator, BA, 3129738490, cpwalia7@gmail.com
- Recruiting
New Century Ophthalmology - Raleigh
Raleigh, North Carolina, 27617
Adriana Valencia, Site Coordinator Raleigh, 9192347406, Adriana@ncophth.com
Chaitan Walia, Study Coordinator, BA, 3129738490, cpwalia7@gmail.com
About this study
Official title: Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
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
- Diabetic Retinopathy (DR)
- Being tested
- Fundus Image Grading
- Keywords
- Artificial Intelligence, Ophthalmic Device, AI, Diabetic Retinopathy, Diabetes, DR, Screening, Online/Offline, Fundus Camera
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fundus Image GradingDiagnostic test
The image is graded by a fully automated AI device
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of AI Grade
AI generated image grades are directly compared to a Human generated image grade
Measured: From time of arrival to completion of diagnostic tests, up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start23 Nov 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artelus AI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinod Jindal, MD, Principal investigator, New Century Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222293
- Sponsor's protocol ID
- 25-02-199
- Status last verified
- Dec 2025
- First submitted
- 25 Oct 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: resource constraints
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations
- ClinicalTrials.gov ID
- NCT07222293
- Acronym / sponsor ID
- 25-02-199
- Conditions
- Diabetic Retinopathy (DR)
- Keywords
- Artificial Intelligence, Ophthalmic Device, AI, Diabetic Retinopathy, Diabetes, DR, Screening, Online/Offline
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Artelus AIIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be referred from primary care clinics and ophthalmology clinics in North Carolina.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (12 listed)
- 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);
- Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fundus Image GradingThe image is graded by a fully automated AI device | Diagnostic test | – |
Primary outcome
Accuracy of AI Grade
Time frame: From time of arrival to completion of diagnostic tests, up to 8 hours
AI generated image grades are directly compared to a Human generated image grade
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. resource constraints
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vinod Jindal, MD principal investigator
New Century Ophthalmology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy (DR), run by Artelus AI at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanne Champion, Primary Site Coordinator Oxford (9192347003, Jeanne@ncophth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of AI Grade (time frame: From time of arrival to completion of diagnostic tests, up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.