[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629178":3},{"organization":4,"outcomesModule":7,"designInfo":81,"detailedDescription":35,"studyPopulation":35,"armGroups":87,"interventions":93,"overallOfficials":99,"centralContacts":119,"locations":129,"responsibleParty":219,"collaborators":221,"id":224,"slug":35,"hasResults":225,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":225,"sex":231,"minAge":232,"maxAge":35,"enrollmentInfo":233,"targetDuration":35,"studyType":236,"phases":237,"briefSummary":239,"conditions":240,"keywords":35,"overallStatus":242,"whyStopped":35,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},{"fullName":5,"class":6},"Carl Zeiss Meditec AG","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Refractive predictability","Difference between predicted Manifest Refraction Spherical Equivalent and achieved Manifest Refraction Spherical Equivalent at the final postoperative visit: Percentage of first implanted eyes within ± 1.0 D","From preoperative visit to the final postoperative visit at twelve months",[14,17,19,22,25,29,33,37,40,42,44,46,48,50,52,54],{"measure":15,"description":16,"timeFrame":12},"Refractive outcomes","Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent",{"measure":10,"description":18,"timeFrame":12},"Percentage of eyes within ± 0.25 D, ± 0.5 D, \\& ± 1.0 D",{"measure":20,"description":21,"timeFrame":12},"Reduction in cylindrical power","The change in manifest refractive cylinder from baseline to the final postoperative visit.",{"measure":23,"description":24,"timeFrame":12},"IOL Rotation","Percentage of IOLs with IOL rotation with less than 10 and 20 degrees.",{"measure":26,"description":27,"timeFrame":28},"Stability of IOL axis orientation","Expressed as percentage of IOLs that rotate ≤ +\u002F- 5 degrees postoperatively","Between 30 to 60 days and 120 to 180 days",{"measure":30,"description":31,"timeFrame":32},"Axis Misalignment","The absolute difference between intended IOL axis orientation and measured IOL axis orientation with less than 10 and 20 degrees.","From baseline to postoperative visit 120-180 days",{"measure":34,"description":35,"timeFrame":36},"Monocular Uncorrected Distance Visual Acuity (UDVA)",null,"12-Month Postoperative",{"measure":38,"description":35,"timeFrame":39},"Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better","12-Months Postoperatively",{"measure":41,"description":35,"timeFrame":39},"Monocular Best-Corrected Distance Visual Acuity (CDVA)",{"measure":43,"description":35,"timeFrame":39},"Monocular Uncorrected Intermediate Visual Acuity (UIVA)",{"measure":45,"description":35,"timeFrame":39},"Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)",{"measure":47,"description":35,"timeFrame":39},"Monocular (1st eye implantations) defocus curve",{"measure":49,"description":35,"timeFrame":39},"Binocular defocus curve on subjects implanted binocularly",{"measure":51,"description":35,"timeFrame":39},"Intraocular Pressure",{"measure":53,"description":35,"timeFrame":39},"Assessment of subject satisfaction, patient reported outcomes, and spectacle independence",{"measure":55,"description":56,"timeFrame":39},"IOL observations","IOL Decentration, Tilt, Discoloration, Opacity, Glistenings",[58,61,64,67,69,72,75,78],{"measure":59,"description":60,"timeFrame":39},"Preservation of Corrected Distance Visual Acuity","Rate of eyes with postoperative CDVA 0.3 logMAR or better",{"measure":62,"description":35,"timeFrame":63},"Contrast Sensitivity","Six-Months Postoperatively",{"measure":65,"description":66,"timeFrame":39},"Posterior Capsule Opacification","Rate of occurrence and grading",{"measure":68,"description":35,"timeFrame":39},"Rate of performed and planned Nd:YAG laser capsulotomies",{"measure":70,"description":71,"timeFrame":39},"Signs of intraocular inflammation","* Anterior chamber cells following Standardization of Uveitis Nomenclature (SUN) grading scheme\n* Anterior chamber flare following SUN grading scheme\n* Vitreous cells, following National Institutes of Health (NIH) grading scheme\n* Cystoid macular oedema\n* Hypopyon\n* Endophthalmitis",{"measure":73,"description":74,"timeFrame":39},"Slit lamp biomicoscopy","* Eyelid\n* Conjunctiva\n* Corneal Edema\n* Other corneal abnormalities",{"measure":76,"description":77,"timeFrame":39},"Fundus examination","* Retina\n* Macula\n* Optic Nerve",{"measure":79,"description":80,"timeFrame":39},"Adverse event rate of Posterior Chamber IOL","As per ISO 11979:2024",{"allocation":82,"interventionModel":83,"interventionModelDescription":35,"primaryPurpose":84,"observationalModel":35,"timePerspective":35,"maskingInfo":85},"NA","SINGLE_GROUP","TREATMENT",{"masking":86,"maskingDescription":35,"whoMasked":35},"NONE",[88],{"label":89,"type":90,"description":35,"interventionNames":91},"Unilateral or bilateral implantation of investigational device","EXPERIMENTAL",[92],"Device: Monofocal toric IOL",[94],{"type":95,"name":96,"description":97,"armGroupLabels":98,"otherNames":35},"DEVICE","Monofocal toric IOL","The device under investigation is a CE-approved monofocal bitoric, aspheric, aberration-correcting intraocular lens indicated for aphakia after surgical extraction of the cataractous natural lens and is also indicated for the correction of regular corneal astigmatism.",[89],[100,104,107,110,113,116],{"name":101,"affiliation":102,"role":103},"Gerd Auffarth, Dr. Med","University Hospital Heidelberg","PRINCIPAL_INVESTIGATOR",{"name":105,"affiliation":106,"role":103},"Andrea Janeková, MD, Ph.D","Eye Centre Prague",{"name":108,"affiliation":109,"role":103},"Iveta Němcová, MD, Ph.D","Military University Hospital, Prague",{"name":111,"affiliation":112,"role":103},"Jiří Pašta, Doc.MUDr","Premium Clinic",{"name":114,"affiliation":115,"role":103},"Satish Srinivasan, M.D","Ayrshire Eye Clinic",{"name":117,"affiliation":118,"role":103},"Pedro Tañá, M.D","Oftalmología Vistahermosa S.L",[120,125],{"name":121,"role":122,"phone":123,"phoneExt":35,"email":124},"Grant Sharpe","CONTACT","+447918937014","grant.sharpe@zeiss.com",{"name":126,"role":122,"phone":127,"phoneExt":35,"email":128},"Linda Villanueva","7143226506","linda.villanueva@zeiss.com",[130,148,158,167,185,202],{"facility":131,"status":35,"city":132,"state":132,"zip":133,"country":134,"countryCode":35,"cosmosGeoPoint":135,"geoPoint":140,"contacts":141},"Oční klinikaO","Prague","18100","Czechia",{"type":136,"coordinates":137},"Point",[138,139],14.42076,50.08804,{"lat":139,"lon":138},[142,146],{"name":143,"role":122,"phone":144,"phoneExt":35,"email":145},"Petra Kasakova","+420734579078","kasakova@premiumclinic.cz",{"name":147,"role":103,"phone":35,"phoneExt":35,"email":35},"Jiří Pašta",{"facility":149,"status":35,"city":132,"state":35,"zip":35,"country":134,"countryCode":35,"cosmosGeoPoint":150,"geoPoint":152,"contacts":153},"Oční Centrum Praha",{"type":136,"coordinates":151},[138,139],{"lat":139,"lon":138},[154,156],{"name":155,"role":122,"phone":35,"phoneExt":35,"email":35},"Study Coordinator",{"name":157,"role":103,"phone":35,"phoneExt":35,"email":35},"Andrea Janeková",{"facility":159,"status":35,"city":132,"state":35,"zip":35,"country":134,"countryCode":35,"cosmosGeoPoint":160,"geoPoint":162,"contacts":163},"Ústřední vojenská nemocnice - Vojenská fakultní nemocnice Praha",{"type":136,"coordinates":161},[138,139],{"lat":139,"lon":138},[164,165],{"name":155,"role":122,"phone":35,"phoneExt":35,"email":35},{"name":166,"role":103,"phone":35,"phoneExt":35,"email":35},"Iveta Němcová",{"facility":168,"status":35,"city":169,"state":35,"zip":170,"country":171,"countryCode":172,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Universitätsklinikum Heidelberg","Heidelberg","69120","Germany","DE",{"type":136,"coordinates":174},[175,176],8.69079,49.40768,{"lat":176,"lon":175},[179,183],{"name":180,"role":122,"phone":181,"phoneExt":35,"email":182},"Raquel Amroussi","+4966215636849","raquel.willrichamroussi@med.uni-heidelberg.de",{"name":184,"role":103,"phone":35,"phoneExt":35,"email":35},"Gerd Auffarth",{"facility":186,"status":35,"city":187,"state":35,"zip":188,"country":189,"countryCode":190,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Ofatlivist Alicante","Alicante","03001","Spain","ES",{"type":136,"coordinates":192},[193,194],-0.48149,38.34517,{"lat":194,"lon":193},[197,200],{"name":198,"role":122,"phone":35,"phoneExt":35,"email":199},"José Rubio","jmrubio@oftalvist.es",{"name":201,"role":103,"phone":35,"phoneExt":35,"email":35},"Pedro Tañá",{"facility":115,"status":35,"city":203,"state":204,"zip":205,"country":206,"countryCode":207,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Ayr","Ayrshire","KA7 2SP","United Kingdom","UK",{"type":136,"coordinates":209},[210,211],-4.63393,55.46273,{"lat":211,"lon":210},[214,217],{"name":155,"role":122,"phone":215,"phoneExt":35,"email":216},"+44 1292 282100","info@ayrshireeyeclinic.com",{"name":218,"role":103,"phone":35,"phoneExt":35,"email":35},"Satish Srinivasan",{"type":220,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[222],{"name":223,"class":6},"targomedGmbH","100629178",false,"NCT07471295","Toric Performance And Constant Evaluation","Prospective Assessment of Constant Optimization and Visual Outcomes Following Monofocal Toric IOL Implantation","PACE","Inclusion Criteria:\n\n* Aged 18 years or older;\n* Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits;\n* Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral phacoemulsification or Femtosecond-Laser-Assisted cataract surgery;\n* Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated.\n* Signed informed consent form;\n* Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment;\n* Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps);\n* Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm;\n* Clear intraocular media other than cataract.\n\nExclusion Criteria:\n\n* Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject;\n* Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye\n* Traumatic cataract;\n* Pregnancy or lactation;\n* Concurrent participation in another drug or device investigation within the last 30 days;\n* Irregular astigmatism;\n* Instability of keratometry or biometry measurements;\n* Subjects wearing contact lenses as standard vision aid;\n* Abnormal pupil;\n* Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.);\n* History of concurrent intraocular inflammation;\n* Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies);\n* History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis;\n* Pseudoexfoliation syndrome (according to investigator judgement);\n* Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;\n* All kind of infections (acute ocular disease, external \u002F internal infection, systemic infection);\n* Monophthalmic patient;\n* Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease\n* Patient expected to require retinal laser treatment before the end of the last follow-up examination;\n* Patient expected to require refractive laser treatment \u002F refractive laser touch-up before the end of the last follow-up examination;\n* Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy)\n* In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day","ALL","18 Years",{"count":234,"type":235},130,"ESTIMATED","INTERVENTIONAL",[238],"PHASE4","The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.",[241],"Cataract","NOT_YET_RECRUITING","2026-03-10",{"date":245,"type":246},"2026-03-13","ACTUAL",{"date":248,"type":235},"2026-05-01",{"date":250,"type":235},"2028-02-28",{"name":5,"class":6},6]