[{"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":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100622079","clinical-efficacy-of-implementing-an-ai-samd-for-funduscopy-analysis-in-patients-with-diabetes-mellitus-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":20,"type":21},340,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Diabetic Retinopathy (DR)","Diabete Mellitus","Fundus Photography","RECRUITING","2026-04-08",{"date":33,"type":34},"2026-04-13","ACTUAL",{"date":36,"type":34},"2026-04-07",{"date":38,"type":21},"2027-08-31",{"name":40,"class":41},"VUNO Inc.","INDUSTRY"]