[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604409":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":23,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":23,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":86,"whyStopped":23,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University Hospital, Motol","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study arm","EXPERIMENTAL","All participants will undergo 3 consecutive examinations - non-mydriatic fundus camera assessed by AI-driven software, fundus opthalmoscopy assessed by experienced opthalmologist and optic coherence tomography examination.",[13,14,15,16],"Diagnostic Test: Non-mydriatic fundus camera photography","Diagnostic Test: Fundus ophtalmoscopy","Diagnostic Test: Optic coherence tomography","Diagnostic Test: Confocal microscopy of the retina",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","Non-mydriatic fundus camera photography","Non-mydriatic fundus camera photography assessed by artificial intelligence software",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Fundus ophtalmoscopy","Fundus opthalmoscopy assessed by an experienced ophtalmologist",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Optic coherence tomography","Optic coherence tomography assessed by an experienced ophtalmologist",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Confocal microscopy of the retina","In a subset of participants over 18 years of age, confocal microscopy of the retina will be performed to assess the presence of diabetic neuropathy",[9],[37],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"Vit Neuman, MD, PhD","CONTACT","+420 224 432 090","Vit.Neuman@fnmotol.cz",[43],{"facility":44,"status":23,"city":45,"state":46,"zip":47,"country":48,"countryCode":23,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University Hospital Motol","Prague","Prague 5","15006","Czechia",{"type":50,"coordinates":51},"Point",[52,53],14.42076,50.08804,{"lat":53,"lon":52},[56],{"name":38,"role":39,"phone":57,"phoneExt":23,"email":41},"+420224432090",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Vit Neuman","MD, PhD","100604409","pediatric-artificial-intelligence-for-retinopathy-screening-in-children-with-type-1-diabetes-100604409",false,"NCT07149142","Pediatric Artificial Intelligence for Retinopathy Screening in Children With Type 1 Diabetes","Feasibility and Effectiveness of Diabetic Retinopathy Screening Using Artificial Intelligence in Children With Type 1 Diabetes","PAIRS-T1D","Inclusion Criteria:\n\n* Type 1 diabetes diagnosed according to the ADA criteria\n* Age over 11.0 years or duration of diabetes over 2 years\n* Signed written informed consent by both the CwD and their parent\u002Fcaregiver\n\nExclusion Criteria:\n\n* Unwillingness to sign a written informed consent by both the CwD and their parent\u002Fcaregiver","ALL","11 Years","19 Years",{"count":74,"type":75},400,"ESTIMATED","INTERVENTIONAL",[78],"NA","The proposed project is a clinical intervention trial testing the feasibility and effectiveness of diabetic retinopathy screening evaluated by artificial intelligence (AI) based software in children with type 1 diabetes (CwD). Another novel method, the confocal microscopy of the retina will be used to assess the early stages of diabetic neuropathy. In parallel, we aim to assess the prevalence of diabetic retinopathy and neuropathy in a well-controlled population of CwD at a tertiary diabetes care center.\n\nEach participant will undergo an examination of diabetic retinopathy using the non-mydriatic fundus camera. The resulting photography will be evaluated by AI driven software. The participant will then follow this examinaton with fundus ophtalmoscopy in arteficial mydriasis as a standard method of diabetic retinopathy assessment. Another method, the optic coherence tomography (OCT), which is considered as the most sensitive method for diabetic retinopathy assessment, will be performed after that. The results of these methods will be compared to assess the sensitivity of each. The examination-satisfaction questionnaire will be given to the participants.\n\nIn subjects over 18 years, a confocal microscopy of the retina examination will be performed to assess the status of the corneal sub-basal nerve plexus and the presence of diabetic neuropathy will be noted.\n\nThe prevalence of diabetic retinopathy and neuropathy in this group of children with diabetes will be assessed based on the results.",[81],"Type 1 Diabetes Mellitus",[83,84,85],"Diabetic Retinopathy","Diabetic Neuropathy","Artificial Intelligence","NOT_YET_RECRUITING","2025-09-10",{"date":89,"type":90},"2025-09-17","ACTUAL",{"date":92,"type":75},"2026-01-01",{"date":94,"type":75},"2029-12-31",{"name":5,"class":6},1]