[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416223":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":68,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":22,"enrollmentInfo":84,"targetDuration":22,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":47,"whyStopped":22,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Diabetic Retinopathy (DR)","EXPERIMENTAL","Screening of DR with artificial intelligence (NeoRetina algorithm) and diagnostic evaluation with a standard of care ophthalmological examination.",[13,14,15],"Diagnostic Test: Screening of DR and DME with artificial intelligence using NeoRetina","Diagnostic Test: Routine ophthalmological evaluation of DR and DME","Diagnostic Test: Manual grading of DR and DME by CHUM ophthalmologists based on retinal photographies acquired by Diagnos",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIAGNOSTIC_TEST","Screening of DR and DME with artificial intelligence using NeoRetina","Macula-centered eye color fundus photos will be acquired by DIAGNOS team using a non-mydriatic digital camera (without pupil dilation). After a numerical treatment, retinal images will be analyzed by NeoRetina artificial intelligence (AI) algorithm in order to find eye lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded by NeoRetina according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Routine ophthalmological evaluation of DR and DME","Standard of care eye examination (blind assessment) will be performed by an ophthalmologist of the CHUM in order to find lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded by the doctor according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Manual grading of DR and DME by CHUM ophthalmologists based on retinal photographies acquired by Diagnos","Ophthalmologists of the CHUM will revise the macula-centered eye color photos acquired by DIAGNOS in order to find lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded (blind assessment) according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.",[9],[32],{"name":33,"affiliation":5,"role":34},"Karim Hammamji, MD","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Marie-Catherine Tessier, MSc","CONTACT","514-890-8000","11550","marie-catherine.tessier.chum@ssss.gouv.qc.ca",{"name":33,"role":38,"phone":39,"phoneExt":40,"email":43},"ophtalmologie.recherche.chum@ssss.gouv.qc.ca",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Centre hospitalier de l'Université de Montréal","RECRUITING","Montreal","Quebec","H2X 0A9","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-73.58781,45.50884,{"lat":57,"lon":56},[60,62,66],{"name":61,"role":38,"phone":39,"phoneExt":40,"email":41},"Marie-Catherine Tessier, M.Sc.",{"name":63,"role":38,"phone":39,"phoneExt":64,"email":65},"Laila Reed Dagher, B.Sc.","11553","laila.reed.dagher.chum@ssss.gouv.qc.ca",{"name":67,"role":34,"phone":22,"phoneExt":22,"email":22},"Karim Hammamji karim.hammamji.med@ssss.gouv.qc.ca, MD",{"type":69,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[71],{"name":72,"class":73},"DIAGNOS Inc.","UNKNOWN","100416223","evaluation-of-neoretina-artificial-intelligence-algorithm-for-the-screening-of-diabetic-retinopathy-at-the-chum-100416223",false,"NCT04699864","Evaluation of NeoRetina Artificial Intelligence Algorithm for the Screening of Diabetic Retinopathy at the CHUM","The Use of Artificial Intelligence in the Early Detection and the Follow-Up of Diabetic Retinopathy of Diabetic Patients Followed at the CHUM: Evaluation of NeoRetina Automated Algorithm (DIAGNOS Inc.)","DR-NeoRetina","Inclusion Criteria:\n\n1. Patients of 18 years old and older;\n2. Ability to provide informed consent;\n3. Diagnostic for diabetes : 3a) Type 1 diabetes of a lest 5 years of evolution; or 3b) Type 2 diabetes;\n4. Diabetic patient followed and refered by a physician of the Centre hospitalier de l'Université de Montréal (CHUM) : 4a) followed by an endocrinologist of the CHUM; or 4b) hospitalized at the CHUM; or 4c) on the waiting list of the Ophthalmology Clinic of the CHUM for the evaluation of DR.\n\nExclusion Criteria:\n\n1. Patients less than 18 years old;\n2. Inability to provide informed consent;\n3. Patient who already had a treatment (surgery, laser, injection, etc.) for any retinal condition : Age-related macular degeneration (AMD), retinal vascular occlusion (RVO); etc.","ALL","18 Years",{"count":85,"type":86},630,"ESTIMATED","INTERVENTIONAL",[89],"NA","This prospective study aims to validate if NeoRetina, an artificial intelligence algorithm developped by DIAGNOS Inc. and trained to automatically detect the presence of diabetic retinopathy (DR) by the analysis of macula centered eye fundus photographies, can detect this disease and grade its severity.",[92,93,94],"Diabetic Retinopathy","Diabetic Macular Edema","Diabetic Maculopathy",[96,97,98,9,99,100,101,102,103,104,105],"Diabetes","Type 1 Diabetes","Type 2 Diabetes","Diabetic Macular Edema (DME)","Ophthalmological Evaluation","Screening of Diabetic Retinopathy","Eye Disease","Eye Complications of Diabetes","Diabetes Mellitus","Artificial Intelligence","2024-09-16",{"date":108,"type":109},"2024-09-19","ACTUAL",{"date":111,"type":109},"2024-06-10",{"date":113,"type":86},"2026-12",{"name":5,"class":6},1]