Implementing Artificial Intelligence to Prevent Vision Loss From Diabetes

NCT07559292 | Enrolling By Invitation

• 3 other identifiers: 2025-1248SMPH | Ophthal and VisualProtocol Version 4/2/24
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vision Disorders; Diabetes

Keywords

Artificial Intelligence; AI; diabetic eye disease; pragmatic

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who get eye screening in the AI and usual-care arms within 5 months of the recommendation

  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

  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

  up to 5 months

Study Arms (2)

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.

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.

Other: AI

Interventions

AI OTHER

AI-based eye screening program

AI Intervention

Usual Practice OTHER

PCP recommends annual vision screening, a separate visit entirely

Usual Care

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serve at least 267 patients with diabetes during the study period
• No point-of-care screening system in use for diabetic eye disease
• Agree to share limited identifiers data as requested
• Age 22 years or older
• Diagnosis of type 1 or 2 diabetes
• No known diabetic eye disease
• No diabetic eye exam in the past 12 months

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Vision Disorders; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Roomsa Channa, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel cluster randomized control trial

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)