[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07559292":3,"trial-entities:NCT07559292":89,"trial-summary:NCT07559292":15},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":47,"sex":52,"minimum_age":53,"maximum_age":15,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":69,"locations":72,"central_contacts":82,"overall_officials":83,"references":87,"see_also_links":88},"NCT07559292","2025-1248","Implementing Artificial Intelligence to Prevent Vision Loss From Diabetes","Implementing Artificial Intelligence (AI) to Prevent Vision Loss From Diabetes","ENROLLING_BY_INVITATION","2027-02","2026-04","2026-04-30","2026-02-15","University of Wisconsin, Madison","OTHER",null,"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.\n\nPrimary Objective:\n\nCompare the odds of patients, who get eye screening in the AI and usual-care arms within 5 months of the recommendation\n\nSecondary Objective:\n\n1. 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\n2. 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",[19,20],"Vision Disorders","Diabetes",[22,23,24,25],"Artificial Intelligence","AI","diabetic eye disease","pragmatic","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[29],"NA",{"count":31,"type":32},1700,"ESTIMATED",[34,38],{"type":14,"name":23,"description":35,"armGroupLabels":36},"AI-based eye screening program",[37],"AI Intervention",{"type":14,"name":39,"description":40,"armGroupLabels":41},"Usual Practice","PCP recommends annual vision screening, a separate visit entirely",[42],"Usual Care",[44],{"measure":45,"timeFrame":46},"Proportion of patients who get eye screening in the AI and usual-care arms within 5 months of the recommendation","up to 5 months",[48,50],{"measure":49,"timeFrame":46},"Proportion of patients, who completed follow-up with recommended eye care in the AI and usual-care arms within 5 months of the recommendation",{"measure":51,"timeFrame":46},"Proportion of patients in different demographic groups who receive eye screening in the AI and usual-care arms within 5 months of the recommendation","ALL","22 Years",true,{"inclusion":56,"exclusion":64,"raw_text":68},[57,58,59,60,61,62,63],"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",[65,66,67],"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","Clinic Inclusion Criteria:\n\n* Serve at least 267 patients with diabetes during the study period\n* No point-of-care screening system in use for diabetic eye disease\n* Agree to share limited identifiers data as requested\n\nPatient Inclusion Criteria:\n\n* Age 22 years or older\n* Diagnosis of type 1 or 2 diabetes\n* No known diabetic eye disease\n* No diabetic eye exam in the past 12 months\n\nExclusion Criteria:\n\n* Have a documented eye exam in the electronic health record within 12 months of the date of the primary care visit.\n* Contraindication includes diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.\n* Pregnant",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"University of Wisconsin","Madison","Wisconsin","53792","United States",{"lat":80,"lon":81},43.07305,-89.40123,[],[84],{"name":85,"affiliation":13,"role":86},"Roomsa Channa, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":90,"biomarkers":92},[91],"Diabetes Mellitus",[]]