[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610825":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":38,"responsibleParty":160,"collaborators":26,"id":162,"slug":163,"hasResults":164,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":26,"eligibilityCriteria":168,"healthyVolunteers":164,"sex":169,"minAge":170,"maxAge":26,"enrollmentInfo":171,"targetDuration":26,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":26,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},{"fullName":5,"class":6},"Biotech Healthcare Holding Gmbh","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.)","EXPERIMENTAL","Patients will be implanted with Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.) IOL based on randomization",[13],"Device: Optiflex TRIO Intraocular Lens",{"label":15,"type":16,"description":17,"interventionNames":18},"AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.)","ACTIVE_COMPARATOR","Patients will be implanted with AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.) based on randomization",[19],"Device: AcrySof® IQ PanOptix®",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Optiflex TRIO Intraocular Lens","The patients will be implanted with Optiflex TRIO IOL at this arm based on randomization. Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is refractive-diffractive trifocal Toric with the anterior surface being aspheric and the posterior surface with a square edge design. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"AcrySof® IQ PanOptix®","The patients will be implanted with AcrySof® IQ PanOptix® at this arm based on randomization. Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is diffractive trifocal with the anterior surface being aspheric and the posterior surface with a toric component. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"BHARGAV D JOSHI, M.Sc.","CONTACT","+917966823000","203","bhargav.joshi@biotechhealthcare.com",[39,64,81,103,123,140],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Internationale Innovative Ophthalmochirurgie GbR","RECRUITING","Düsseldorf","North Rhine-Westphalia","40212","Germany","DE",{"type":48,"coordinates":49},"Point",[50,51],6.77927,51.22319,{"lat":51,"lon":50},[54,58,61],{"name":55,"role":34,"phone":56,"phoneExt":26,"email":57},"Clinical Study Coordinator, optometrist","0049 0211 6006600","m.kirca@augenchirurgie.clinic",{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Dr. Detlev Breyer, Cataract & Refractive Surgeon","PRINCIPAL_INVESTIGATOR",{"name":62,"role":63,"phone":26,"phoneExt":26,"email":26},"Kristin Lena Arzt, MD, FEBO","SUB_INVESTIGATOR",{"facility":65,"status":41,"city":66,"state":43,"zip":67,"country":45,"countryCode":46,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Augentagesklinik","Greven","48268",{"type":48,"coordinates":69},[70,71],7.59396,52.09364,{"lat":71,"lon":70},[74,77,79],{"name":75,"role":34,"phone":76,"phoneExt":26,"email":26},"Edda Clinical Study Coordinator, Optometrist","0049 0800 3 100 900",{"name":78,"role":60,"phone":26,"phoneExt":26,"email":26},"Dr. Karen Sophie Glandorf, MD",{"name":80,"role":63,"phone":26,"phoneExt":26,"email":26},"Elisabeth Bari-Kacik, Specialist Ophthalmologist",{"facility":65,"status":41,"city":82,"state":43,"zip":83,"country":45,"countryCode":46,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Rheine","48429",{"type":48,"coordinates":85},[86,87],7.44055,52.28509,{"lat":87,"lon":86},[90,93,95,97,99,101],{"name":55,"role":34,"phone":91,"phoneExt":26,"email":92},"0049 0 800 3 100 900","a.gerling@precise.vision",{"name":94,"role":60,"phone":26,"phoneExt":26,"email":26},"Dr. Florian Kretz, MD, FEBO",{"name":96,"role":63,"phone":26,"phoneExt":26,"email":26},"David Beckers, MD",{"name":98,"role":63,"phone":26,"phoneExt":26,"email":26},"Lena Beckers, MD",{"name":100,"role":63,"phone":26,"phoneExt":26,"email":26},"Jil-Catherine Große-Volksbeck, MD",{"name":102,"role":63,"phone":26,"phoneExt":26,"email":26},"Frauke Jürgens, Specialist Ophthalmologist",{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Netradhama Superspeciality Eye Hospital","NOT_YET_RECRUITING","Bangalore","Karnatak","560082","India","IN",{"type":48,"coordinates":112},[113,114],77.59369,12.97194,{"lat":114,"lon":113},[117,121],{"name":118,"role":34,"phone":119,"phoneExt":26,"email":120},"Aditi chowdhary, Optometrist","+9196935 10981","research@nethradhama.org",{"name":122,"role":60,"phone":26,"phoneExt":26,"email":26},"Dr. Sri Ganesh, Cataract & Refractive Surgeon",{"facility":124,"status":41,"city":125,"state":126,"zip":127,"country":109,"countryCode":110,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Dr. Agarwal Eye Hospital","Chennai","Tamil Nadu","600018",{"type":48,"coordinates":129},[130,131],80.27847,13.08784,{"lat":131,"lon":130},[134,138],{"name":135,"role":34,"phone":136,"phoneExt":26,"email":137},"Shalini Ramasamy, Optometrist","+91 82202 87800","shalini.r@dragarwal.com",{"name":139,"role":60,"phone":26,"phoneExt":26,"email":26},"Dr. Ashvin Agarwal, M.S. (Opthalmology)",{"facility":141,"status":41,"city":142,"state":142,"zip":143,"country":144,"countryCode":145,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Hospital Arruzafa","Córdoba","14012","Spain","ES",{"type":48,"coordinates":147},[148,149],-4.77275,37.89155,{"lat":149,"lon":148},[152,156,158],{"name":153,"role":34,"phone":154,"phoneExt":26,"email":155},"David Cerdan Clinical Study Coordinator, Optometrist","0034 957 40 10 40","dcerdan@hospitalarruzafa.com",{"name":157,"role":60,"phone":26,"phoneExt":26,"email":26},"Antonio Cano Ortiz, Cataract & Refractive Surgeon",{"name":159,"role":63,"phone":26,"phoneExt":26,"email":26},"Alberto Villarubia Cuadrado",{"type":161,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100610825","a-planned-study-at-multiple-sites-is-being-done-to-compare-the-results-of-two-types-of-trifocal-toric-intraocular-lenses-used-in-cataract-surgery-100610825",false,"NCT07232615","A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal Toric Intraocular Lenses Used in Cataract Surgery","A Prospective, Multicenter Clinical Study Comparing Outcomes of Two Trifocal Toric Intraocular Lens","Inclusion Criteria:\n\n1. Age of patient \\>21 Years\n2. Patient diagnosed with cataract.\n3. Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry\n4. Calculated IOL power is within the range of investigational IOLs.\n5. Patient willing to sign inform consent form.\n6. Clear intraocular media other than cataract.\n7. Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.\n\nExclusion Criteria:\n\n1. Previous intraocular or corneal surgery.\n2. Traumatic cataract\n3. Pregnancy (as stated by patient) or lactation.\n4. Concurrent participation in another drug or device investigation.\n5. Irregular astigmatism.\n6. Patient receiving chlorquine treatment.\n7. Subjects with any systemic disease that could increase operative risk or confound the outcome.\n8. Active ocular disease in the operative eye other than cataract.\n9. Vulnerable subjects as defined in section 12.3.9.\n10. Corneal Astigmatism \\> 4.5 D","ALL","21 Years",{"count":172,"type":173},138,"ESTIMATED","INTERVENTIONAL",[176],"NA","To evaluate the clinical outcomes and patient satisfaction of two commercially available trifocal toric intraocular lenses Primary Objective: To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses. Secondary Objectives: To assess and compare the safety of two trifocal toric intraocular lenses.",[179,180,181],"Presbyopia Correction","Astigmatism","Cataract","2025-11-14",{"date":184,"type":185},"2025-11-18","ACTUAL",{"date":187,"type":185},"2021-11-22",{"date":189,"type":173},"2027-02",{"name":5,"class":6},6]