An interventional study of AI and Usual Practice in Vision Disorders and Diabetes, sponsored by University of Wisconsin, Madison. Enrolling by invitation at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Health services research
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.
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:
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's planned enrollment of 1,700 is above the median of 78 across 244 interventional studies indexed under Vision Disorders.
Browse Vision Disorders studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinic Inclusion Criteria:
Patient Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Usual Practice
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.
Other: AI
AI-based eye screening program
PCP recommends annual vision screening, a separate visit entirely
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
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
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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