[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467301":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":44,"interventions":57,"overallOfficials":65,"centralContacts":69,"locations":32,"responsibleParty":74,"collaborators":32,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":32,"enrollmentInfo":87,"targetDuration":32,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":32,"overallStatus":97,"whyStopped":32,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":32},{"fullName":5,"class":6},"LensGen, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":32},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Distance-corrected intermediate ETDRS LogMar visual acuity","Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm","12 Months",{"measure":14,"description":15,"timeFrame":12},"Distance-corrected intermediate ETDRS LogMar visual acuity vs Control","Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group",{"measure":17,"description":18,"timeFrame":12},"Defocus curve testing with ETDRS chart","Monocular diopters of depth of focus (DOF)",{"measure":20,"description":21,"timeFrame":12},"Best corrected distance ETDRS LogMar visual acuity vs control","Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group",{"measure":23,"description":24,"timeFrame":12},"Best corrected distance ETDRS LogMar visual acuity","Monocular photopic best corrected distance visual acuity (BCDVA)",[26,29],{"measure":27,"description":28,"timeFrame":12},"Distance-corrected near ETDRS LogMar visual acuity","Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm",{"measure":30,"description":31,"timeFrame":12},"Distance-corrected near ETDRS LogMar visual acuity vs control","Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","SINGLE_GROUP","A prospective, randomized, controlled, double-masked, phased, multicenter clinical study","TREATMENT",{"masking":39,"maskingDescription":40,"whoMasked":41},"DOUBLE","The subject will be masked to randomization assignment and will be unmasked at the completion of the study. Scheduled masked postoperative assessments will be performed by a masked examiner",[42,43],"PARTICIPANT","CARE_PROVIDER",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Investigational IOL","EXPERIMENTAL","Juvene® IOL",[50],"Device: Juvene IOL",{"label":52,"type":53,"description":54,"interventionNames":55},"Control IOL","ACTIVE_COMPARATOR","Tecnis® Monofocal (ZCB00, PCB00 or DCB00)",[56],"Device: Tecnis® Monofocal (ZCB00, PCB00 or DCB00)",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":32},"DEVICE","Juvene IOL","Cataract extraction and implantation of a posterior chamber IOL",[46],{"type":59,"name":54,"description":61,"armGroupLabels":64,"otherNames":32},[52],[66],{"name":67,"affiliation":5,"role":68},"Patrick R Casey, O.D.","STUDY_DIRECTOR",[70],{"name":67,"role":71,"phone":72,"phoneExt":32,"email":73},"CONTACT","(949) 472-5112","info@lensgen.com",{"type":75,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100467301","clinical-study-to-evaluate-the-lensgen-juvene-intraocular-lens-100467301",false,"NCT05364983","Clinical Study to Evaluate the LensGen® Juvene® Intraocular Lens","A Prospective, Randomized, Controlled, Double-Masked, Phased, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of the LensGen® Juvene® Intraocular Lens","Nirvana","Key Inclusion Criteria:\n\n* Subjects must be 22 years of age or older\n* Able to comprehend and provide written informed consent\n* Willing and able to comply with schedule for follow-up visits\n* Demonstrate sufficient cognitive awareness to comply with examination procedures\n* Other inclusion criteria specified in the protocol may apply.\n\nKey Exclusion Criteria:\n\n* Subjects with clinically significant dry eye syndrome (DES) expected to impact postoperative visual acuity\n* Subjects taking medications that may affect ocular function (including but not limited to mydriatic, cycloplegic and miotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, and anticholinergic agents)\n* Prior intraocular or corneal surgery (including corneal refractive correction i.e., LASIK, PRK, etc.)\n* Any corneal dystrophy that may affect visual acuity (e.g., keratoconus, pellucid corneal degeneration, etc.)\n* Other exclusion criteria specified in the protocol may apply.",true,"ALL","22 Years",{"count":88,"type":89},56,"ESTIMATED","INTERVENTIONAL",[92],"NA","To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.",[95,96],"Cataract","Presbyopia","NOT_YET_RECRUITING","2023-03-07",{"date":100,"type":101},"2023-03-09","ACTUAL",{"date":103,"type":89},"2023-05",{"date":105,"type":89},"2026-11",{"name":5,"class":6}]