[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496710":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":46,"collaborators":26,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":26,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pilot Phase","ACTIVE_COMPARATOR","12 patients with glaumatous optic neuropathy",[13],"Behavioral: Pilot Phase: standardized behavioral task",{"label":15,"type":16,"description":17,"interventionNames":18},"Validation Phase","PLACEBO_COMPARATOR","66 patients with glaumatous optic neuropathy 12 subjects with no known visual impairment",[19],"Behavioral: Validation Phase: standardized behavioral task",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Pilot Phase: standardized behavioral task","Pilot Phase:\n\n* Mobility under variable light conditions (scotopic, photopic, glare, dark adaptation), performed in a virtual environment.\n* Visual search for objects in real life scenes (office, kitchen, living room) performed in a virtual environment.\n* Ability to drive (UFOV and DVFAT psychophysical tests).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Validation Phase: standardized behavioral task","Validation Phase:\n\n* Mobility in variable light conditions (photopic and scotopic), performed in real and virtual environments.\n* Visual search for objects in real scenes (office, kitchen, bedroom, living room) performed in a virtual environment.\n* Driving ability (two psychophysical tests UFOV and DVFAT, one supervised road test).",[15],[32],{"name":33,"affiliation":34,"role":35},"Christophe BAUDOUIN, Pr","Hôpital National de la Vision des15-20","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Nabil BROUK","CONTACT","+33140021126","nbrouk@15-20.fr",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Hayet SERHANE","+33140021144","hserhane@15-20.fr",{"type":47,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100496710","streetlab-assessment-tool-of-activities-daily-living-in-glaucoma-patient-100496710",false,"NCT05747781","STReetlab Assessment Tool of Activities Daily Living in Glaucoma Patient","Validation of Standardized Tests Allowing the Evaluation of the Impacts of Glaucomatous Optic Neuropathy in Daily Life Activities","STRATAL-GL","Inclusion Criteria:\n\nGlaucoma patients:\n\n* Age: 18 - 80 years,\n* Visual acuity of at least 6\u002F10th binocular,\n* Patient followed at Quinze-Vingts and presenting with chronic stable glaucoma defined by the glaucoma ophthalmologist,\n* MMSE questionnaire score ≥ 25\u002F30 or ≥ 16\u002F25 (if the patient no longer drives),\n* Ability to give consent and comply with the study protocol,\n* Person with Social Security coverage.\n* Recruitment of glaucoma patients will be based on the criteria defined by the HPA classification (Appendix) on the basis of the Humphrey visual field, for categorization of patients into three stages of optic neuropathy progression (early stage \"1\", moderate \"2\" and advanced \"3\").\n\nFor the optional roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers (GL and VS) who report being:\n\n* Always drivers in possession of a valid driver's license,\n* Driven at least 500 km in the past year.\n\nHealthy volunteer:\n\n* Age: 18 - 80 years.\n* Age and sex matching between healthy volunteers and glaucoma patients (± 5 years).\n* MMSE questionnaire score ≥ 25\u002F30.\n* Visual acuity of at least 10\u002F10th in binocular.\n* Ability to give consent and comply with the study protocol.\n* Person with a Social Security plan.\n\nFor the roadside fitness visit (V4), specific inclusion criteria will be required for this study: the roadside assessment will be performed with volunteers who declare themselves:\n\n* Always drivers in possession of a valid driver's license,\n* Driven at least 500 km in the past year.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Inability to personally give consent.\n* Participants will not have neurodegenerative diseases or any other disease that could interfere with the assessments planned during this study.\n* Participants will not have any other ophthalmologic diseases other than glaucoma.\n* Drug treatments that may cause motor, visual, or cognitive impairment (PSAs, neuroleptics, etc.) or that may interfere with the study assessments.\n* Condition that limits ability to move.\n* Inability to read.",true,"ALL","18 Years","80 Years",{"count":61,"type":62},100,"ESTIMATED","INTERVENTIONAL",[65],"NA","The impact of glaucomatous optic neuropathy on the daily life of patients is poorly characterized and does not benefit from standardized tests.\n\nThe development and validation of new tests could be used to assess the efficacy of innovative treatments for visually impaired patients and\u002For optimize management strategies.",[68],"Optic Neuropathy","NOT_YET_RECRUITING","2023-02-17",{"date":72,"type":73},"2023-02-28","ACTUAL",{"date":75,"type":62},"2023-03-01",{"date":77,"type":62},"2027-03-31",{"name":5,"class":6}]