Diabetic Retinopathy (DR)DRES POCAINCT06721351

Diabetic Retinopathy Screening Point-of-Care Artificial Intelligence

A study testing Diabetic Retinopathy screening Point of Care Artificial Intelligence in people with Diabetic Retinopathy (DR), run by Centro De Salud La Comunidad De San Ysidro Inc DBA: San Ysidro Health at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 22 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetic Retinopathy (DR)
What is being tested?: Diabetic Retinopathy screening Point of Care Artificial Intelligence
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 548 participants
Where: 3 sitesUnited States
Study dates: 27 Jul 2024to 30 Apr 2026
Phase: Interventional
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 22 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Capacity to provide informed consent. Individuals must have the capacity to understand the study information, risks, and benefits and voluntarily provide informed consent.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Established and active patient of SYHealth-CV and KC (having a medical appointment in the last 18 months).
Person aged 22 and older.
Established diagnosis of DM.
Medical appointment(s) (in-person or telehealth) scheduled during the intervention period.
Has not completed a dilated eye exam or retinal exam in the last 11months.

Who cannot join

have a prior diagnosis of DR, macular edema, or retinal vascular occlusion;
have persistent visual Impairment in one or both eyes;
history of ocular injections, laser treatment of the retina, or intraocular surgery (excluding cataract surgery);
pregnant women; and
diagnosis of mental or degenerative disease that prevents self-consent for the study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

San Ysidro Health Chula Vista
Chula Vista, California, 91910
San Ysidro Health - Comprehensive Health Center - Ocean View
San Diego, California, 92113
San Ysidro Health King-Chavez Health Center
San Diego, California, 92114

Other trials in United States

About this study

Official title: Diabetic Retinopathy Screening Point-of-Care Artificial Intelligence -DRES-POCAI: AI - Clinical Intervention at San Ysidro Health

This research study is being conducted to improve eye care by using artificial intelligence (AI) to make diabetic eye screenings faster and more accessible. AI technology mimics human decision-making, enabling computers and systems to analyze medication information. Specifically for this screening, AI examines digital images of the eye and based on that information, may identify if a participant has diabetic retinopathy. It can assist doctors in making decisions about a participant's diagnosis, treatment or care plans to improve patient care. This is a collaboration between San Ysidro Health (SYHealth), University of California, San Diego (UC San Diego), and Eyenuk. The Kaiser Permanente Augmented Intelligence in Medicine and Healthcare Initiative (AIM-HI) awarded SYHealth funds to demonstrate the value of AI technologies in diverse, real-world settings.

Read the detailed description

This study is intended to address unmet medical needs in diabetic eye care in a community health center setting by enhancing and modifying existing clinical practices with the integration of point-of-care (POC) artificial intelligence (AI) technology for Diabetic Retinopathy (DR) screening. Using a special camera and a computer system called EyeArt® to make diabetic eye screenings faster and more accessible. EyeArt®, is a Food Drug and Administration (FDA)-cleared device system for fast, non-invasive Diabetic retinopathy screening. This non-invasive DR screening does not require dilation and provides immediate results and facilitates informed discussions with their primary care provider. This study will optimize, implement, and test the impact of a multicomponent intervention that includes: 1) autonomous DR screening, a fast and non-invasive retinal exam into the primary care settings with 2) integration of the results into the EHR and 3) health education/care coordination support (e.g., patient education). Primary Objective (Clinical): Evaluate the implementation and effectiveness of a multicomponent AI clinical intervention on DR screenings rate, early stages of DR detection, and referrals to the specialist for follow up on abnormal results. Secondary Objectives: Evaluate the implementation and effectiveness of a multicomponent AI clinical intervention on DR knowledge, attitudes, self-efficacy, and patient satisfaction.

Participants will be active SYHealth patients 22 years of age or older with diabetes mellitus (DM) who have not had a retinal exam in the last 11 months, and have a medical visit scheduled during the intervention period and are able to read and understand either English or Spanish in order to provide informed consent and complete study surveys. Exclusion criteria: 1) have a prior diagnosis of DR, macular edema, or retinal vascular occlusion; 2) have persistent visual Impairment in one or both eyes; 3) history of ocular injections, laser treatment of the retina, or intraocular surgery (excluding cataract surgery); 4) pregnant women; and 5) diagnosis of mental or degenerative disease that prevents self-consent for the study. The study will recruit a cohort of 848 adults from two SYHealth clinic sites.

Once the potential participants arrive at their study visit appointment, they will complete the consent process, pre-survey (knowledge, attitudes and self-efficacy about diabetes and eye health). Participants will be randomized into either the DR screening-AI-intervention or retinal screening usual care groups and continue study activities as follows:

Participants assigned to the DR screening-AI-intervention group will undergo DR screening in-clinic prior to the medical visit using a special camera and the EyeArt® Artificial Intelligence (AI) system (Eyenuk, Inc.), an FDA-cleared AI device for fast, non-invasive DR screening. This screening, which does not require dilation, uses a camera with a smart computer technology using AI that can detect signs of significant diabetic retinopathy in less than five minutes. These results will be immediately integrated into the electronic health record (EHR), enabling informed discussions with their primary care provider at the time of their medical visit and will automatically generate the referrals to an eye specialist for participants with abnormal findings. Participants will receive a copy of the results immediately after completion of the screening. After the screening, participants will receive a copy of the results of the screening, health education information on DR and eye health before completing their baseline study visit. Subsequently, they will proceed with their medical visit to ensure continuity of their diabetes care.
Participants in the retinal screening usual care group will receive assistance from the RA to schedule the appointment with an eye care provider according to SYHealth's protocols for routine retinal screening, which includes dilation. After the RA scheduled the visit with the eye care provider, participants will receive health education information on DR and eye health before completing their baseline study visit. Subsequently, they will proceed with their medical visit to ensure continuity of their diabetes care.

Appointments with the eye care provider are usually at a different clinic location based on availability, and the retinal screenings are not completed on the same day of the medical visit with their primary care provider. At the time of the visit with the eye care provider will discuss the retinal screening results with the participant and may conduct a comprehensive eye exam, submitting referrals for any abnormal results.

Conditions: Diabetic Retinopathy (DR)
Being tested: Diabetic Retinopathy screening Point of Care Artificial Intelligence
Keywords: Point-of-care (POC) artificial intelligence (AI) technology for DR screening, Diabetic Retinopathy (DR) Screening, Diabetes
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.

Diabetic Retinopathy screening Point of Care Artificial IntelligenceDiagnostic test
Random assignment of participants to intervention and control groups minimizes confounding variables. This ensures that any observed differences in outcomes are likely due to the intervention itself and not pre-existing differences between the groups. Participants of the DRES-POCAI study will be randomized into two groups: usual care (receive a retinal screening by an optometrist) or intervention group (receive a retinal screening using a special camera and EyeArt® system, an autonomous AI-based DR screening). The randomization will occur after consenting and completing the surveys, prior to conducting the DR screening process (for those randomized to the intervention group).

Study groups in NCT06721351
Study group	Role	What they receive
Usual care	No intervention	The usual care group will complete the DR screening with an eye care provider on a different day and at a different location. The study staff will facilitate this process for participants in the usual care group by assisting them in scheduling appointments for their routine retinal screening.
Diabetic Retinopathy Screening	Experimental	The intervention group will complete the DR screening using a special camera and the AI system (EyeArt®), the same day of the study visit. Participants assigned to the intervention group will also receive a retinal screening without dilation using the EyeArt® AI system; the DR screening will be completed before their medical provider visits. The results will be available immediately after the screening, allowing participants to learn about and discuss their eye health with their care provider. Receives: Diagnostic Test: Diabetic Retinopathy screening Point of Care Artificial Intelligence

What is being measured

The primary outcome is the main question the study is designed to answer.

DR screening completion and result
1. Completion of DR screening. Data obtained through EHR at the time of the enrollment (baseline) and through study completion, an average of 1 year.
2. Results of DR screening: usual care specific diagnosis; intervention group defined as normal, mild-to-moderate DR), visual threatening DR or ungradable. Referral to specialist completion status and final diagnosis.
Measured: the enrollment (baseline) and through study completion, an average of 1 year
DR screening efficiency
EyeArt system impact and efficiency data, number of orders submitted, screenings completed (images), number of ungradable and time of attempts, time (minutes) the participant spent in front of the camera.
Measured: the enrollment (baseline) and through study completion, an average of 1 year
Knowledge and attitudes about DR
5 min-survey at baseline and 6 months. Assessment of participant knowledge and attitudes about DR (10 multiple choice question survey).
Measured: Baseline survey at study visit and follow up survey 6-months after.
DM self-efficacy
5 min-survey at baseline and 6 months. Assessment of participant DM self-efficacy (seven questions using a 5-point scale from "Strongly disagree" to "Strongly agree).
Measured: Baseline survey at study visit and follow up survey 6-months after.
DM self-management
5 min-survey at baseline and 6 months. Assessment of participant DM self-management ( 5-point scale from "Very difficult: I couldn't do it at all" to "Not difficult: I could do all of I).
Measured: Baseline survey at study visit and follow up survey 6-months after.
DR Screening Satisfaction Survey (Intervention Group)
5 min-survey at baseline and 6 months. Assessment of participant satisfaction with POC DR screening (three questions using a 5-point scale from "Strongly disagree" to "Strongly agree, three multiple choice questions, and one open text field).
Measured: Baseline survey at study visit and follow up survey 12-months after (at next DR screening).
Demographic and Clinical Data
Participant level demographics (e.g., sex assigned at birth, gender, age, race, ethnicity, marital status, employment status, insurance type etc.) and clinical data will be extracted from the electronic health record to obtain participant level information on comorbidities, medication use and compliance with quality methods and as applicable selected patient visit history.
Measured: Intake at study 1 day visit.
Social Determinants of Health
Participant information on non-medical factors (e.g., socioeconomic status, employment, housing stability, food insecurity, education, social support networks, living environment, alcohol/tobacco consumption) that could influence health outcomes will be collected.
Measured: Intake at study 1 day visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jul 202430 Apr 2026

First posted6 Dec 2024
Study start27 Jul 2024
Primary completion31 Dec 2025 (estimated)
Study completion30 Apr 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Model description: The DRES-POCAI study uses a randomized controlled, open-label, parallel superiority trial. Randomization: Participants will be randomized into two groups: usual care (receive a retinal screening by an optometrist) or intervention group (receive a retinal screening using a special camera and FDA-cleared EyeArt® system, an autonomous AI-based DR screening). Open-label Design: Blinding participants and providers to the autonomous DR screening is logistically difficult. The intervention's immediate results and potential impact on the workflow necessitate an open-label approach. Parallel Design: The parallel design allows for a clear, side-by-side comparison of outcomes between the intervention and usual care groups over time. Superiority Evaluation: The primary objective is to determine if the multi-component DRES-POCAI intervention is superior to usual care in increasing DR screenings, early detection, referrals, and patient knowledge/self-efficacy.
Masking: None (open label)
Enrolment: 548 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06721351
Sponsor's protocol ID: RHP-091323-159
Other IDs: 212825-SYH-04
Acronym: DRES POCAI
Status last verified: Nov 2025
First submitted: 20 Nov 2024
Last updated: 6 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Diaz EA, Seifert ML, Gruning V, Stadnick NA, Lugo-Butler E, Servin AN, Rodriguez-Rosales CI, Geremia C, Ramachandra C, Bhaskaranand M, Howard D, Solis O, Velasquez S, Snook B, Tucker S, Munoz FA. Diabetic Retinopathy Screening Among Federally Qualified Health Center Patients Using Point-of-Care AI: DRES-POCAI: A Trial Protocol. JAMA Netw Open. 2025 Oct 1;8(10):e2538114. doi: 10.1001/jamanetworkopen.2025.38114.
PubMed 41118165

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetic Retinopathy (DR) trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diabetic Retinopathy Screening Point-of-Care Artificial Intelligence -DRES-POCAI: AI - Clinical Intervention at San Ysidro Health
ClinicalTrials.gov ID: NCT06721351
Acronym / sponsor ID: DRES POCAI / RHP-091323-159
Conditions: Diabetic Retinopathy (DR)
Keywords: Point-of-care (POC) artificial intelligence (AI) technology for DR screening, Diabetic Retinopathy (DR) Screening, Diabetes
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 548 participants (actual)
Lead sponsor: Centro De Salud La Comunidad De San Ysidro Inc DBA: San Ysidro HealthUniversity, hospital or other
Collaborators: Eyenuk, Inc., University of California, San Diego
Study start: 27 Jul 2024 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 30 Apr 2026 (estimated)
First posted: 6 Dec 2024 (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.

Detailed description

Participants assigned to the DR screening-AI-intervention group will undergo DR screening in-clinic prior to the medical visit using a special camera and the EyeArt® Artificial Intelligence (AI) system (Eyenuk, Inc.), an FDA-cleared AI device for fast, non-invasive DR screening. This screening, which does not require dilation, uses a camera with a smart computer technology using AI that can detect signs of significant diabetic retinopathy in less than five minutes. These results will be immediately integrated into the electronic health record (EHR), enabling informed discussions with their primary care provider at the time of their medical visit and will automatically generate the referrals to an eye specialist for participants with abnormal findings. Participants will receive a copy of the results immediately after completion of the screening. After the screening, participants will receive a copy of the results of the screening, health education information on DR and eye health before completing their baseline study visit. Subsequently, they will proceed with their medical visit to ensure continuity of their diabetes care.
Participants in the retinal screening usual care group will receive assistance from the RA to schedule the appointment with an eye care provider according to SYHealth's protocols for routine retinal screening, which includes dilation. After the RA scheduled the visit with the eye care provider, participants will receive health education information on DR and eye health before completing their baseline study visit. Subsequently, they will proceed with their medical visit to ensure continuity of their diabetes care.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: The DRES-POCAI study uses a randomized controlled, open-label, parallel superiority trial. Randomization: Participants will be randomized into two groups: usual care (receive a retinal screening by an optometrist) or intervention group (receive a retinal screening using a special camera and FDA-cleared EyeArt® system, an autonomous AI-based DR screening). Open-label Design: Blinding participants and providers to the autonomous DR screening is logistically difficult. The intervention's immediate results and potential impact on the workflow necessitate an open-label approach. Parallel Design: The parallel design allows for a clear, side-by-side comparison of outcomes between the intervention and usual care groups over time. Superiority Evaluation: The primary objective is to determine if the multi-component DRES-POCAI intervention is superior to usual care in increasing DR screenings, early detection, referrals, and patient knowledge/self-efficacy.

Arm	Type	Receives
Usual care	No intervention	–The usual care group will complete the DR screening with an eye care provider on a different day and at a different location. The study staff will facilitate this process for participants in the usual care group by assisting them in scheduling appointments for their routine retinal screening.
Diabetic Retinopathy Screening	Experimental	Diagnostic Test: Diabetic Retinopathy screening Point of Care Artificial IntelligenceThe intervention group will complete the DR screening using a special camera and the AI system (EyeArt®), the same day of the study visit. Participants assigned to the intervention group will also receive a retinal screening without dilation using the EyeArt® AI system; the DR screening will be completed before their medical provider visits. The results will be available immediately after the screening, allowing participants to learn about and discuss their eye health with their care provider.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Capacity to provide informed consent. Individuals must have the capacity to understand the study information, risks, and benefits and voluntarily provide informed consent.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Established and active patient of SYHealth-CV and KC (having a medical appointment in the last 18 months).
Person aged 22 and older.
Established diagnosis of DM.

Key exclusion criteria (5 listed)

have a prior diagnosis of DR, macular edema, or retinal vascular occlusion;
have persistent visual Impairment in one or both eyes;
history of ocular injections, laser treatment of the retina, or intraocular surgery (excluding cataract surgery);
pregnant women; and
diagnosis of mental or degenerative disease that prevents self-consent for the study.

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
Diabetic Retinopathy screening Point of Care Artificial IntelligenceRandom assignment of participants to intervention and control groups minimizes confounding variables. This ensures that any observed differences in outcomes are likely due to the intervention itself and not pre-existing differences between the groups. Participants of the DRES-POCAI study will be randomized into two groups: usual care (receive a retinal screening by an optometrist) or intervention group (receive a retinal screening using a special camera and EyeArt® system, an autonomous AI-based DR screening). The randomization will occur after consenting and completing the surveys, prior to conducting the DR screening process (for those randomized to the intervention group).	Diagnostic test	Diabetic Retinopathy Screening

Primary outcome

DR screening completion and result
Time frame: the enrollment (baseline) and through study completion, an average of 1 year
1. Completion of DR screening. Data obtained through EHR at the time of the enrollment (baseline) and through study completion, an average of 1 year. 2. Results of DR screening: usual care specific diagnosis; intervention group defined as normal, mild-to-moderate DR), visual threatening DR or ungradable. Referral to specialist completion status and final diagnosis.
DR screening efficiency
Time frame: the enrollment (baseline) and through study completion, an average of 1 year
EyeArt system impact and efficiency data, number of orders submitted, screenings completed (images), number of ungradable and time of attempts, time (minutes) the participant spent in front of the camera.
Knowledge and attitudes about DR
Time frame: Baseline survey at study visit and follow up survey 6-months after.
5 min-survey at baseline and 6 months. Assessment of participant knowledge and attitudes about DR (10 multiple choice question survey).
DM self-efficacy
Time frame: Baseline survey at study visit and follow up survey 6-months after.
5 min-survey at baseline and 6 months. Assessment of participant DM self-efficacy (seven questions using a 5-point scale from "Strongly disagree" to "Strongly agree).
DM self-management
Time frame: Baseline survey at study visit and follow up survey 6-months after.
5 min-survey at baseline and 6 months. Assessment of participant DM self-management ( 5-point scale from "Very difficult: I couldn't do it at all" to "Not difficult: I could do all of I).
DR Screening Satisfaction Survey (Intervention Group)
Time frame: Baseline survey at study visit and follow up survey 12-months after (at next DR screening).
5 min-survey at baseline and 6 months. Assessment of participant satisfaction with POC DR screening (three questions using a 5-point scale from "Strongly disagree" to "Strongly agree, three multiple choice questions, and one open text field).
Demographic and Clinical Data
Time frame: Intake at study 1 day visit.
Participant level demographics (e.g., sex assigned at birth, gender, age, race, ethnicity, marital status, employment status, insurance type etc.) and clinical data will be extracted from the electronic health record to obtain participant level information on comorbidities, medication use and compliance with quality methods and as applicable selected patient visit history.
Social Determinants of Health
Time frame: Intake at study 1 day visit.
Participant information on non-medical factors (e.g., socioeconomic status, employment, housing stability, food insecurity, education, social support networks, living environment, alcohol/tobacco consumption) that could influence health outcomes will be collected.

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 6 Nov 2025.
Derived from this study: PubMed 41118165Diaz EA, Seifert ML, Gruning V, Stadnick NA, Lugo-Butler E, Servin AN, Rodriguez-Rosales CI, Geremia C, Ramachandra C, Bhaskaranand M, Howard D, Solis O, Velasquez S, Snook B, Tucker S, Munoz FA. Diabetic Retinopathy Screening Among Federally Qualified Health Center Patients Using Point-of-Care AI: DRES-POCAI: A Trial Protocol. JAMA Netw Open. 2025 Oct 1;8(10):e2538114. doi: 10.1001/jamanetworkopen.2025.38114.
Individual participant dataSharing planned: No

Related trials for Diabetic Retinopathy (DR)

Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
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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. This study is not recruiting at the moment.

Fatima Muñoz, MD, MPH principal investigator

San Ysidro Health

Nicole Stadnick, PhD principal investigator

University of California, San Diego

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DR screening completion and result (time frame: the enrollment (baseline) and through study completion, an average of 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06721351, which also lists 1 linked publication.

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 6 Nov 2025.