[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fundus-photography\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fundus-photography":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100622079",false,"NCT07378956","Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus","Clinical Efficacy of Implementing an AI-Driven Software as a Medical Device (SaMD) for Funduscopy Analysis in Patients With Diabetes Mellitus: A Randomized Controlled Trial Protocol","SAFE-DM","Inclusion Criteria:\n\n* Adults aged 19 years or older.\n* A documented diagnosis of type 2 diabetes mellitus.\n* Ability to communicate adequately and provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* A prior diagnosis of diabetic retinopathy at the time of screening.\n* A history of ophthalmic surgery within 6 months prior to the screening date.\n* A diagnosis of type 1 diabetes mellitus.\n* Pregnancy at the time of screening.\n* Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.","ALL","19 Years",{"count":19,"type":20},340,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.",[26,27,28],"Diabetic Retinopathy (DR)","Diabete Mellitus","Fundus Photography","RECRUITING","2026-04-08",{"date":32,"type":33},"2026-04-13","ACTUAL",{"date":35,"type":33},"2026-04-07",{"date":37,"type":20},"2027-08-31",{"name":39,"class":40},"VUNO Inc.","INDUSTRY",""]