[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646637":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Vienna Hospital Association","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tecnis PureSee","EXPERIMENTAL","Bilateral implantation of the Tecnis PureSee refractive extended depth-of-focus IOL (Johnson \\& Johnson Vision; non-toric model ZEN00V or toric DET series). The same lens platform is implanted in both eyes. Target refraction: emmetropia in the dominant eye and approximately -0.50 D in the non-dominant eye.",[13],"Device: Tecnis PureSee IOL implantation",{"label":15,"type":16,"description":17,"interventionNames":18},"1stQ Comfort Z-EDOF","ACTIVE_COMPARATOR","Bilateral implantation of the 1stQ Comfort Z-EDOF refractive extended depth-of-focus IOL (1stQ GmbH; non-toric models B1XBY0\u002FS1XBY0 or toric B1ZBY0). The same lens platform is implanted in both eyes. Target refraction: emmetropia in the dominant eye and approximately -0.50 D in the non-dominant eye.",[19],"Device: 1stQ Comfort Z-EDOF IOL implantation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Tecnis PureSee IOL implantation","Phacoemulsification with bilateral implantation of the Tecnis PureSee refractive EDOF IOL in the capsular bag. Toric variant used for preoperative corneal astigmatism greater than 0.75 D.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"1stQ Comfort Z-EDOF IOL implantation","Phacoemulsification with bilateral implantation of the 1stQ Comfort Z-EDOF refractive EDOF IOL in the capsular bag. Toric variant used for preoperative corneal astigmatism greater than 0.75 D.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Michal Klimek, MD","CONTACT","+43 650 460 7496","klimek.michael@gmx.at",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Augenabteilung, Klinik Hietzing, Wiener Gesundheitsverbund","Vienna","State of Vienna","1130","Austria","AT",{"type":46,"coordinates":47},"Point",[48,49],16.37208,48.20849,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":53,"phoneExt":26,"email":36},"+43 6504607496",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Prim. Univ.-Prof. Dr. Pia Veronika Vécsei-Marlovits, MSc, MB","Prim.a Univ.-Prof.in Dr.in Pia Veronika Vécsei-Marlovits, MSc, MBA","100646637","prospective-randomized-parallel-group-comparison-of-two-refractive-edof-intraocular-lenses-johnson--johnson-tecnis-puresee-versus-1stq-comfort-z-edof-100646637",false,"NCT07688681","Prospective, Randomized, Parallel-group Comparison of Two Refractive EDOF Intraocular Lenses: Johnson & Johnson Tecnis PureSee Versus 1stQ Comfort Z-EDOF","1stQvsPureSee","Inclusion Criteria:\n\n* Age ≥40 years, able to understand the study and give written informed consent\n* Clinically significant bilateral age-related cataract suitable for phacoemulsification with posterior chamber IOL implantation\n* Expected postoperative best-corrected visual acuity ≤0.2 logMAR in both eyes\n* Regular corneal astigmatism ≤4.5 D in both eyes (IOLMaster 700)\n* Axial length 21.5-26.5 mm in both eyes\n* Clear cornea without clinically significant opacities, scars, or stromal dystrophies\n* Normal pupil function; no significant anisocoria (≥1 mm) and no afferent pupillary defect\n* Acceptance of the target refraction strategy: emmetropia in the dominant eye and -0.50 D in the non-dominant eye\n* Willing and able to attend all follow-up visits (Month 1, 3, and 6)\n* Written informed consent obtained before any study-related procedure\n\nExclusion Criteria:\n\n* Prior corneal refractive surgery, corneal transplantation, glaucoma filtering surgery, or vitreoretinal surgery in either eye (uncomplicated intravitreal injections allowed)\n* Irregular astigmatism, keratoconus, forme fruste keratoconus, corneal ectasia, significant corneal opacities or scars, or endothelial dystrophy\n* Keratometric astigmatism \\>4.5 D in either eye\n* Axial length \\\u003C21.5 mm or \\>26.5 mm in either eye\n* Calculated IOL power outside the available range of either study lens\n* Macular pathology expected to limit visual acuity (e.g., age-related macular degeneration, diabetic maculopathy, epiretinal membrane, macular hole)\n* Advanced glaucoma with central visual field involvement, or IOP not controlled on ≤2 topical medications\n* Optic neuropathy expected to limit visual potential\n* Pre-existing amblyopia in either eye\n* Significant anisocoria, afferent pupillary defect, non-dilating pupil, or iris abnormalities affecting IOL function or measurement\n* Endothelial cell density \\\u003C1500 cells\u002Fmm²\n* Uncontrolled diabetes mellitus (HbA1c \\>9%) or autoimmune disease with active ocular involvement\n* Systemic medications affecting pupil size that cannot be discontinued (e.g., tamsulosin)\n* Pregnancy or breastfeeding\n* Intraoperative complication precluding safe in-the-bag IOL implantation (affected eyes withdrawn)\n* Cognitive impairment, language barrier, or other factors preventing reliable participation\n* Current enrollment in another interventional clinical study affecting visual outcomes","ALL","40 Years",{"count":68,"type":69},110,"ESTIMATED","INTERVENTIONAL",[72],"NA","This study compares two types of artificial lens (intraocular lens, or IOL) used during cataract surgery. Both are extended depth-of-focus (EDOF) lenses, designed to give clear vision across a range of distances - far and intermediate - so that people depend less on glasses after surgery. The two lenses, the Tecnis PureSee and the 1stQ Comfort Z-EDOF, use different optical designs, and it is not yet known whether one provides a wider range of clear vision than the other.\n\nAdults having cataract surgery in both eyes may take part. Each participant is randomly assigned to receive one of the two lens types, and the same lens type is implanted in both eyes. Neither the participant nor the staff measuring vision knows which lens was used until the main 6-month assessment is complete.\n\nAfter surgery, participants attend check-ups at 1, 3, and 6 months. The study measures how wide a range of distances each person can see clearly, along with vision at different distances, quality of vision, side effects such as glare or halos, and overall satisfaction. The results will help doctors and patients choose between these lens types.",[75],"Cataract",[77],"EDOF intraocular lens","NOT_YET_RECRUITING","2026-06-30",{"date":81,"type":82},"2026-07-07","ACTUAL",{"date":84,"type":69},"2026-08-01",{"date":86,"type":69},"2029-04-01",{"name":5,"class":6},1]