[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570033":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":20,"interventions":26,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":64,"collaborators":13,"id":66,"slug":13,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":13,"studyType":80,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":88,"whyStopped":13,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Essilor International","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Light discomfort thresholds","Amount of light (in lux) that produce a defined discomfort level (just perceptible or really disturbing)","2 hours",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE",[21],{"label":22,"type":23,"description":13,"interventionNames":24},"Glare discomfort measures with filters","EXPERIMENTAL",[25],"Other: Filter comparison",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":13},"OTHER","Filter comparison","Three filters will be compared on light discomfort thresholds using the Lumiz 100™ device",[22],[33],{"name":34,"affiliation":5,"role":35},"Pascale Lacan, Phd","STUDY_DIRECTOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":13,"email":41},"Pascale Lacan, PhD","CONTACT","+33155964816","lacanp@essilor.fr",[43],{"facility":44,"status":13,"city":45,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Institut des Sciences de la Vision","Saint-Etienne","France","42100","FR",{"type":50,"coordinates":51},"Point",[52,53],4.39,45.43389,{"lat":53,"lon":52},[56,60,62],{"name":57,"role":39,"phone":58,"phoneExt":13,"email":59},"Aurore Munier, Doctor of Optometry","+ 33 (0) 4 77 95 31 70","a.munier@isvision.fr",{"name":61,"role":39,"phone":13,"phoneExt":13,"email":13},"Aurore Munier, Doctor of optometry",{"name":63,"role":39,"phone":13,"phoneExt":13,"email":13},"Sophie Comte, Doctor of optometry",{"type":65,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100570033",false,"NCT06701981","Study on the Effect of Filters on Discomfort Glare on Healthy Adults","Etude De L'Effet De Filtres Sur L'Eblouissement D'Inconfort","PREVIS","Inclusion Criteria:\n\n* A willing person, fluent in French, inclined to follow protocol, capable of reading and understanding the information form, and able to give their free and informed consent.\n* Beneficiary of the French Social Security system\n* Aged 18 to 65 years\n* No or moderate ocular correction (Spherical prescription for distance vision: in the range \\[-8.00 to +6.00 D\\]\\* (negative cylinder) for each eye; Cylindrical prescription for distance vision: in the range \\[0 to -4.00 D\\] for each eye; Anisometropia ≤ 2.00 D on the equivalent sphere)\n* Correct vision with prescription glasses (Corrected visual acuity +0.10 logMAR or better (distance vision \u002F high contrast \u002F photopic luminance)\n* Regular user of sunglasses at least in bright light conditions\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years (i.e., no minors in accordance with Article L1121-7 of the Public Health Code of \"Code de Santé Publique\")\n* Pregnant, parturient, or breastfeeding women (Article L1121-5 of the Public Health Code of \"Code de Santé Publique\")\n* Persons deprived of liberty by judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, and persons admitted to a health or social institution for purposes other than research\n* Adults incapable or unable to express their consent (Article L1121-8 of the Public Health Code of \"Code de Santé Publique\")\n* Participant in the exclusion period of another biomedical research study\n* Participant who cannot be contacted in case of emergency\n* All categories of persons particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code)\n* Employees at the Institut des Sciences de la Vision or EssilorLuxottica\n* Ocular pathology that may affect vision (e.g., glaucoma involving visual field loss, maculopathy involving visual acuity loss, or retinitis pigmentosa causing significant discomfort in poorly or overly lit environments)\n* Neurological deficit, including a history of epileptic pathology or regular or severe migraines\n* Ocular surgery affecting vision (e.g., refractive surgery, cataract surgery, or iridectomy)\n* Ocular or head trauma",true,"ALL","18 Years","65 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[15],"The goal of this clinical trial is to evaluate the glare protection provided by two filters compared to no filter. Using the Lumiz 100™ device (a headset with gradually increasing light), participants will measure their discomfort thresholds under three different conditions (one per filter). Each measurement will be repeated three times. The study requires a single visit of 2 hours for each participant. Glare protection will be quantified by comparing discomfort thresholds across the no-filter condition and the two studied filters.",[84],"Glare",[86,87],"glare","filter","NOT_YET_RECRUITING","2024-11-20",{"date":91,"type":92},"2024-11-22","ACTUAL",{"date":94,"type":79},"2024-12-02",{"date":96,"type":79},"2025-03-31",{"name":5,"class":6},1]