[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598296":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":50,"collaborators":52,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":32,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Assisted Screening","EXPERIMENTAL","Intervention group (physicians assisted by AI): After the fundus photography is completed, the AI software (VeriSee AMD and VeriSee DR) will automatically retrieve and analyze the image data from Picture Archiving and Communication System (PACS) to generate the results. The research team will immediately provide the AI-generate results to physicians, enabling participants to receive their reports and results during the same visit. If any abnormalities are detected, the physicians will refer the participants for further ophthalmologic evaluation.",[13],"Other: VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degeneration",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Physician Screening","ACTIVE_COMPARATOR","Control group (physicians diagnosing without AI assistance): After the fundus photography is completed, participants will need to schedule a follow-up appointment with the attending physicians to receive their report and have preliminary assessment of the possibility of DR or AMD. If the physician detects any abnormalities, the physicians will refer the participants for further ophthalmologic evaluation.",[19],"Other: Standard fundus photography with physician interpretation",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"VeriSee AI-assisted screening tools for diabetic retinopathy and age-related macular degeneration","VeriSee DR is an AI-assisted diagnosis screening tool for diabetic retinopathy, the software received medical device license approval from the TFDA in 2020 (MOHW-MD-No.006966). VeriSee AMD is an AI-assisted diagnosis screening tool for age-related macular degeneration, the software also received medical device license approval from the TFDA in 2022 (MOHW-MD-No.007652).",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard fundus photography with physician interpretation","The control group will undergo the fundus photography without AI-functionality, with reports interpreted solely by physicians. Participants must schedule a follow-up visit to receive their results.",[15],[31],{"facility":5,"status":32,"city":33,"state":25,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Taipei","100225","Taiwan","TW",{"type":38,"coordinates":39},"Point",[40,41],121.52639,25.05306,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"Yi-Ting Hsieh, Medical Doctor","CONTACT","+886-2-2312-3456","265018","ythyth@gmail.com",{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[53,56,58],{"name":54,"class":55},"Ministry of Health and Welfare, Taiwan","OTHER_GOV",{"name":57,"class":6},"Fu Jen Catholic University Hospital",{"name":59,"class":6},"Min-Sheng General Hospital","100598296","artificial-intelligence-aided-screening-for-patients-with-diabetic-retinopathy-and-age-related-macular-degeneration-in-family-medicine-and-geriatric-medicine-outpatient-clinics-100598296",false,"NCT07069647","Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics","Artificial Intelligence-Aided Screening for Patients With Diabetic Retinopathy and Age-related Macular Degeneration in Family Medicine and Geriatric Medicine Outpatient Clinics: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* VeriSee AMD is used in non-retinal subspecialty ophthalmology clinics for adults aged 50 and above.\n* VeriSee DR is used in non-retinal subspecialty clinics for diabetic patients aged 20 and above.\n\nExclusion Criteria:\n\n* The patient does not agree to participate in the trial or is unable to provide informed consent.","ALL","20 Years",{"count":70,"type":71},4300,"ESTIMATED","INTERVENTIONAL",[74],"NA","Diabetic retinopathy (DR) and age-related macular degeneration (AMD) are leading causes of vision loss, with rising incidence due to aging populations and increasing diabetes prevalence. However, delayed diagnoses are common due to low disease literacy and lack of dedicated screening tools in internal medicine. This multi-center RCT at National Taiwan University Hospital evaluates the clinical effectiveness and cost-effectiveness of the VeriSee AI-assisted diagnostic software for DR and AMD screening. Participants include adults with diabetes and individuals aged 50 and above meeting AMD screening criteria, randomized to AI-assisted screening with immediate physician explanation or standard physician-only screening. Primary outcomes include detection rates of DR and AMD, ophthalmology referral outcomes, and patient\u002Fphysician satisfaction. Data collection will occur from April 2025 to December 2027. This study aims to provide evidence on the clinical utility of AI-assisted ophthalmic screening in improving early detection, facilitating timely treatment, and reducing severe visual impairment and healthcare burdens in real-world clinical settings.",[77,78],"Age-Related Macular Degeneration (AMD)","Diabetic Retinopathy (DR)",[77,78,80,81,82],"Artificial Intelligence","Randomized Controlled Trial","Fundus Photography","2025-11-16",{"date":85,"type":86},"2025-11-19","ACTUAL",{"date":88,"type":86},"2025-10-02",{"date":90,"type":71},"2027-12-31",{"name":5,"class":6},1]