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OpenTrials
Enrolling by Invitation

NCT Number: NCT07559292

Implementing Artificial Intelligence 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.

Enrolling by Invitation

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Clinic Inclusion Criteria:

  • 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

Patient Inclusion Criteria:

  • 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

Exclusion criteria

  • 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

Treatment and study plan

AI

Other

AI-based eye screening program

Usual practice

Other

PCP recommends annual vision screening, a separate visit entirely

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Implementing Artificial Intelligence (AI) to Prevent Vision Loss From Diabetes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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