[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535967":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":39,"locations":50,"responsibleParty":79,"collaborators":26,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":26,"enrollmentInfo":91,"targetDuration":26,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":53,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Cutting Edge SAS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LuxBoost Group","EXPERIMENTAL","the experimental group will receive the LuxBoost intraocular lens.",[13],"Device: LuxBoost IOL",{"label":15,"type":16,"description":17,"interventionNames":18},"LuxGood group","ACTIVE_COMPARATOR","the control group will receive the LuxGood parent intraocular lens.",[19],"Device: LuxGood IOL",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","LuxBoost 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],[31,35],{"name":32,"affiliation":33,"role":34},"Vincent GUALINO","Clinique Honoré Cave 82000 Montauban","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":38},"Christophe CESSES","Cutting Edge S.A.S (Sponsor)","STUDY_DIRECTOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Ilham XHAARD","CONTACT","620 050 651","+33","ilham.xhaard@cutting-edge.fr",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Line BETTINELLI","619 530 701","line.bettinelli@cutting-edge.fr",[51,67],{"facility":52,"status":53,"city":54,"state":26,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Clinique Honore Cave","RECRUITING","Montauban","82000","France","FR",{"type":59,"coordinates":60},"Point",[61,62],1.3542,44.01759,{"lat":62,"lon":61},[65],{"name":66,"role":34,"phone":26,"phoneExt":26,"email":26},"Vincent GUALINO, Dr",{"facility":68,"status":53,"city":69,"state":26,"zip":70,"country":56,"countryCode":57,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"West Ophta","Rennes","35000",{"type":59,"coordinates":72},[73,74],-1.67431,48.11109,{"lat":74,"lon":73},[77],{"name":78,"role":34,"phone":26,"phoneExt":26,"email":26},"Pierre-Emmanuel ARCADE, Dr",{"type":80,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100535967","bicentric-clinical-investigation-to-assess-safety-and-performance-of-luxboost-iol-100535967",false,"NCT06258707","Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL","Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.","LuxBoost","Inclusion Criteria:\n\n* Subject aged 50 or over on the day of inclusion, presenting a\n* bilateral cataract for which posterior chamber IOL implantation\n* has been planned.\n* Fit within the available IOL diopter range.\n* Have had no previous refractive surgery.\n* Regular corneal astigmatism \\\u003C 1 dioptre by an automatic\n* keratometer (regularity measured by topographer).\n* Availability, willingness, and sufficient cognitive awareness to\n* 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* Subjects suffering from diagnosed degenerative visual disorders\n* Pre-existing ocular pathology\n* Acute or chronic disease or illness that would increase risk or confound study results\n* Axial lengths and keratometry such as the IOL spherical power is\n* not in the range of 14 to 28 D\n* Instability of keratometry or biometry measurements\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","ALL","50 Years",{"count":92,"type":93},58,"ESTIMATED","INTERVENTIONAL",[96],"NA","The study purpose is to demonstrate safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens.",[99],"Aphakia",[101],"Enhanced monofocal IOL","2026-02-11",{"date":104,"type":105},"2026-02-12","ACTUAL",{"date":107,"type":105},"2024-10-14",{"date":109,"type":93},"2027-06-15",{"name":5,"class":6},2]