Vision DisordersNCT07559292
Implementing Artificial Intelligence to Prevent Vision Loss From Diabetes
A study testing AI and Usual Practice in people with Vision Disorders and Diabetes, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This pragmatic clinical trial is being conducted to test the effectiveness of AI in improving screening and follow-up eye care compared to usual-care among patients with diabetes across 4 primary care clinics. This is an autonomous AI-based screening to detect diabetic eye disease at primary care visits. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Disorders, Diabetes
- What is being tested?
- AI and Usual Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2026to Feb 2027
- 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
None listed.
Who cannot join
- Have a documented eye exam in the electronic health record within 12 months of the date of the primary care visit.
- Contraindication includes diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementing Artificial Intelligence (AI) to Prevent Vision Loss From Diabetes
This pragmatic clinical trial is being conducted to test the effectiveness of AI in improving screening and follow-up eye care compared to usual-care among patients with diabetes across 4 primary care clinics. This is an autonomous AI-based screening to detect diabetic eye disease at primary care visits.
Read the detailed description
Four clinics from two health systems will be recruited, with two clinics from each health system and randomly assigned to either usual-care or the AI Intervention with 2 clinics assigned to each arms. Beginning in month 3, a 6-week baseline period will be conducted in all clinics, followed by a 4-month intervention period for the two clinics assigned to AI.
Primary Objective:
Compare the odds of patients, who get eye screening in the AI and usual-care arms within 5 months of the recommendation
Secondary Objective:
- Compare the odds of patients, who completed follow-up with recommended eye care in the AI and usual-care arms within 5 months of the recommendation
- Compare the odds of patients in different demographic groups who receive eye screening in the AI and usual-care arms within 5 months of the recommendation
- Conditions
- Vision Disorders, Diabetes
- Being tested
- AI, Usual Practice
- Keywords
- Artificial Intelligence, AI, diabetic eye disease, pragmatic
- Medical subject headings
- Vision Disorders, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIOther
AI-based eye screening program
Usual PracticeOther
PCP recommends annual vision screening, a separate visit entirely
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Patients with diabetes will follow the clinic's usual practice, in which the primary care provider recommends an annual screening eye exam for patients with diabetes. This requires the patient to make a separate visit to see an eye care provider. Clinic staff will provide scheduling assistance per the standard scheduling procedure for the clinic. Receives: Other: Usual Practice |
| AI Intervention | Experimental | AI intervention includes (1) acquisition of eye photos and (2) autonomous (i.e. without human oversight) AI-based identification of referrable or non-referrable eye disease at the primary care clinic. Receives: Other: AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who get eye screening in the AI and usual-care arms within 5 months of the recommendation
Measured: up to 5 months
Secondary outcomes (2)
Proportion of patients, who completed follow-up with recommended eye care in the AI and usual-care arms within 5 months of the recommendation
Measured: up to 5 months
Proportion of patients in different demographic groups who receive eye screening in the AI and usual-care arms within 5 months of the recommendation
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start15 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision DisordersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel cluster randomized control trial
- Masking
- None (open label)
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roomsa Channa, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559292
- Sponsor's protocol ID
- 2025-1248
- Other IDs
- SMPH | Ophthal and Visual, Protocol Version 4/2/24
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Artificial Intelligence (AI) to Prevent Vision Loss From Diabetes
- ClinicalTrials.gov ID
- NCT07559292
- Acronym / sponsor ID
- 2025-1248
- Conditions
- Vision Disorders, Diabetes
- Keywords
- Artificial Intelligence, AI, diabetic eye disease, pragmatic
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 30 Apr 2026 (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.
This pragmatic clinical trial is being conducted to test the effectiveness of AI in improving screening and follow-up eye care compared to usual-care among patients with diabetes across 4 primary care clinics. This is an autonomous AI-based screening to detect diabetic eye disease at primary care visits.
Detailed description
Four clinics from two health systems will be recruited, with two clinics from each health system and randomly assigned to either usual-care or the AI Intervention with 2 clinics assigned to each arms. Beginning in month 3, a 6-week baseline period will be conducted in all clinics, followed by a 4-month intervention period for the two clinics assigned to AI.
Primary Objective:
Compare the odds of patients, who get eye screening in the AI and usual-care arms within 5 months of the recommendation
Secondary Objective:
- Compare the odds of patients, who completed follow-up with recommended eye care in the AI and usual-care arms within 5 months of the recommendation
- Compare the odds of patients in different demographic groups who receive eye screening in the AI and usual-care arms within 5 months of the recommendation
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel cluster randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual PracticePatients with diabetes will follow the clinic's usual practice, in which the primary care provider recommends an annual screening eye exam for patients with diabetes. This requires the patient to make a separate visit to see an eye care provider. Clinic staff will provide scheduling assistance per the standard scheduling procedure for the clinic. |
| AI Intervention | Experimental | Other: AIAI intervention includes (1) acquisition of eye photos and (2) autonomous (i.e. without human oversight) AI-based identification of referrable or non-referrable eye disease at the primary care clinic. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Have a documented eye exam in the electronic health record within 12 months of the date of the primary care visit.
- Contraindication includes diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
- Pregnant
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 |
|---|---|---|
| AIAI-based eye screening program | Other | AI Intervention |
| Usual PracticePCP recommends annual vision screening, a separate visit entirely | Other | Usual Care |
Primary outcome
Proportion of patients who get eye screening in the AI and usual-care arms within 5 months of the recommendation
Time frame: up to 5 months
2 secondary outcomes
Proportion of patients, who completed follow-up with recommended eye care in the AI and usual-care arms within 5 months of the recommendation
Time frame: up to 5 months
Proportion of patients in different demographic groups who receive eye screening in the AI and usual-care arms within 5 months of the recommendation
Time frame: up to 5 months
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 30 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
Roomsa Channa, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI and Usual Practice in people with Vision Disorders and Diabetes, run by University of Wisconsin, Madison at 1 site 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 0 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Proportion of patients who get eye screening in the AI and usual-care arms within 5 months of the recommendation (time frame: up to 5 months). 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 30 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.