[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550418":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":92,"collaborators":26,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":26,"enrollmentInfo":104,"targetDuration":26,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Cutting Edge SAS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LuxHighAdd","EXPERIMENTAL","The experimental group will recieve the LuxHighAdd intraocular lens bilaterally.",[13],"Device: LuxHighAdd IOL",{"label":15,"type":16,"description":17,"interventionNames":18},"LuxGood group","ACTIVE_COMPARATOR","The control group will recieve the LuxGood intraocular lens bilaterally.",[19],"Device: LuxGood IOL",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","LuxHighAdd IOL","Bilateral implantation in the capsular bag to replace the cataractous human crystalline lens.",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"LuxGood IOL",[15],[31],{"name":32,"affiliation":33,"role":34},"Alain Saad, MD","Hôpital Fondation Adolphe de Rothschild","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Line Bettinelli, OD","CONTACT","0619530701","line.bettinelli@bausch.com",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Christophe Cesses","0786991458","christophe.cesses@bausch.com",[46,65,81],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Centre d'Ophtalmologie des Dr Rozot et associés","RECRUITING","Marseille","13008","France","FR",{"type":54,"coordinates":55},"Point",[56,57],5.38107,43.29695,{"lat":57,"lon":56},[60,63],{"name":61,"role":38,"phone":62,"phoneExt":26,"email":26},"Dr Rozot, MD","+334 91 22 24 29",{"name":64,"role":34,"phone":26,"phoneExt":26,"email":26},"Pascal ROZOT, MD",{"facility":66,"status":48,"city":67,"state":26,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Clinique Honoré Cave","Montauban","82000",{"type":54,"coordinates":70},[71,72],1.3542,44.01759,{"lat":72,"lon":71},[75,79],{"name":76,"role":38,"phone":77,"phoneExt":26,"email":78},"Cloé Sanchez","+33563030304","cloe.sanchez@clinique-honore-cave.com",{"name":80,"role":34,"phone":26,"phoneExt":26,"email":26},"Vincent GUALINO, MD",{"facility":33,"status":48,"city":82,"state":26,"zip":83,"country":51,"countryCode":52,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Paris","75019",{"type":54,"coordinates":85},[86,87],2.3488,48.85341,{"lat":87,"lon":86},[90,91],{"name":32,"role":38,"phone":26,"phoneExt":26,"email":26},{"name":32,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":93,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100550418","multicentric-clinical-investigation-to-assess-safety-and-performance-of-lux-highadd-iol-100550418",false,"NCT06446817","Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL","Multicentric Clinical Investigation to Determine Safety and Efficacy of a Hydrophobic Acrylic Multifocal Intraocular Lens","HIGHADD","Inclusion Criteria:\n\n* Subject aged 50 or over on the day of inclusion, presenting a bilateral cataract, qualified for bilateral implantation\n* No ocular comorbidity possibly affecting the study results\n* Fit within the available IOL diopter range\n* Have had no previous refractive surgery\n* Regular corneal astigmatism ≤1.0 dioptres\n* Clear intraocular media other than cataract\n* Availability, willingness and sufficient cognitive awareness to comply with examination procedures\n* Ability to attend all study follow-ups\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Ocular surface disease potentially affecting study results\n* Pre-existing ocular pathology or history of pathology potentially affecting the study results\n* Acute or chronic disease or illness that would increase risk or confound study results\n* Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy)\n* Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D\n* Instability of keratometry or biometry measurements\n* Traumatic cataract\n* Amblyopia\n* History of ocular trauma or any prior ocular surgery including refractive procedures\n* Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens\n* Pupil abnormalities\n* Systemic or ocular medication that could modify pupil dynamics\n* Expected complicated surgery or complicated surgery\n* Concurrent participation in another drug or device investigation","ALL","50 Years",{"count":105,"type":106},57,"ESTIMATED","INTERVENTIONAL",[109],"NA","The study purpose is to demonstrate safety and performance of bilateral implantation of LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens.",[112],"Cataract","2026-05-21",{"date":115,"type":116},"2026-05-26","ACTUAL",{"date":118,"type":116},"2024-12-19",{"date":120,"type":106},"2028-12",{"name":5,"class":6},3]