[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605644":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":11,"studyPopulation":11,"armGroups":39,"interventions":49,"overallOfficials":11,"centralContacts":11,"locations":55,"responsibleParty":78,"collaborators":11,"id":81,"slug":11,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":11,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":11,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"OMIQ Research","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Distance-corrected binocular defocus curve at 4 m",null,"3 months",[14,17,21,24,27],{"measure":15,"description":16,"timeFrame":12},"Monocular and binocular, corrected and uncorrected distance, intermediate, and near visual acuities","Visual acuities in logMAR scale using ETDRS (Early Treatment Diabetic Retinopathy Study) charts",{"measure":18,"description":19,"timeFrame":20},"Distance-corrected contrast sensitivity","Contrast sensitivity using M\\&S device","Three months",{"measure":22,"description":23,"timeFrame":12},"Low contrast (25%) binocular distance-corrected visual acuity","Contrast sensitivity in logMAR scale using low contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts",{"measure":25,"description":26,"timeFrame":12},"Visual dysfunction assessment using the QUVID (Questionnaire for visual disturbances) questionnaire","Assessment of qualitative visual dysphotopsia using a specific validated questionnaire",{"measure":28,"description":29,"timeFrame":12},"Spectacle independence assessment using the IOLSAT (Intraocular lens satisfaction) questionnaire","Assessment of recent use of spectacles to see at different distances using a specific questionnaire",{"allocation":31,"interventionModel":32,"interventionModelDescription":11,"primaryPurpose":33,"observationalModel":11,"timePerspective":11,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":11,"whoMasked":36},"DOUBLE",[37,38],"PARTICIPANT","OUTCOMES_ASSESSOR",[40,45],{"label":41,"type":42,"description":11,"interventionNames":43},"Extended depth of focus intraocular lens Clareon Vivity","EXPERIMENTAL",[44],"Device: Phacoemulsification with implantation of an extended depth of focus intraocular lens",{"label":46,"type":47,"description":11,"interventionNames":48},"Extended depth of focus intraocular lens PureSee","ACTIVE_COMPARATOR",[44],[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":11},"DEVICE","Phacoemulsification with implantation of an extended depth of focus intraocular lens","Comparison of two different Extended depth of focus intraocular lenses",[41,46],[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Sant Cugat del Vallès","Barcelona","08195","Spain","ES",{"type":64,"coordinates":65},"Point",[66,67],2.08611,41.47063,{"lat":67,"lon":66},[70,75],{"name":71,"role":72,"phone":73,"phoneExt":11,"email":74},"Anna Romero, Administration","CONTACT","+34937071936","asdireccio@omiq.es",{"name":76,"role":77,"phone":11,"phoneExt":11,"email":11},"Mercè Guarro, MD","PRINCIPAL_INVESTIGATOR",{"type":77,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Merce Guarro","MD","100605644",false,"NCT07165197","Visual Performance of Clareon Vivity and PureSee IOL","Visual Performance of Clareon® Vivity® and PureSee® Intraocular Lenses in Patients Undergoing Cataract Surgery","PURVI2","Inclusion Criteria:\n\n* Patients of any sex and race aged 50 years or older\n* Patients undergoing bilateral age-related cataract surgery with a lens opacity grade 3 or higher in the LOCS III grading scale\n* Willing to receive implantation of an EDOF IOL\n* Willing to sign the informed consent and attend the study visits\n\nExclusion Criteria:\n\n* Requirement of a spherical or toric power of the IOL to achieve emmetropia beyond the available range of either of the two lenses\n* The number of patients included with low astigmatism that require an equivalent to a T2 toric IOL will be capped to 10 patients\u002Fgroup\n* Irregular astigmatism\n* Contact lens wear in the previous 3 weeks before biometry\n* Moderate or severe ocular surface, corneal, macular or optic nerve disease that in opinion of the investigator precludes the desired functional results\n* History of previous refractive, cornea, retina or glaucoma surgery\n* Eyes with a clear lens demanding a refractive lens exchange\n* Amblyopia in any eye\n* Significant previous ocular trauma\n* Pregnancy\n* A systemic condition that, in the opinion of the investigator, precludes the reliable assessments required in the study (i.e., dementia) or participation in the study (i.e., severe mobility problems).","ALL","50 Years",{"count":91,"type":92},80,"ESTIMATED","INTERVENTIONAL",[95],"NA","This is study to determine the visual performance of patients with age-related cataracts implanted in both eyes with either of two extended depth of focus intraocular lenses, the Clareon Vivity (Alcon Healthcare) or the PureSee (Johnson \\& Johnson)",[98],"Cataract","2025-09-02",{"date":101,"type":102},"2025-09-10","ACTUAL",{"date":104,"type":102},"2025-06-27",{"date":106,"type":92},"2026-03",{"name":5,"class":6},1]