Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:15 AM
Study NCT ID:
NCT07471295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toric Performance And Constant Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Preservation of Corrected Distance Visual Acuity', 'timeFrame': '12-Months Postoperatively', 'description': 'Rate of eyes with postoperative CDVA 0.3 logMAR or better'}, {'measure': 'Contrast Sensitivity', 'timeFrame': 'Six-Months Postoperatively'}, {'measure': 'Posterior Capsule Opacification', 'timeFrame': '12-Months Postoperatively', 'description': 'Rate of occurrence and grading'}, {'measure': 'Rate of performed and planned Nd:YAG laser capsulotomies', 'timeFrame': '12-Months Postoperatively'}, {'measure': 'Signs of intraocular inflammation', 'timeFrame': '12-Months Postoperatively', 'description': '* 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': 'Slit lamp biomicoscopy', 'timeFrame': '12-Months Postoperatively', 'description': '* Eyelid\n* Conjunctiva\n* Corneal Edema\n* Other corneal abnormalities'}, {'measure': 'Fundus examination', 'timeFrame': '12-Months Postoperatively', 'description': '* Retina\n* Macula\n* Optic Nerve'}, {'measure': 'Adverse event rate of Posterior Chamber IOL', 'timeFrame': '12-Months Postoperatively', 'description': 'As per ISO 11979:2024'}], 'primaryOutcomes': [{'measure': 'Refractive predictability', 'timeFrame': 'From preoperative visit to the final postoperative visit at twelve months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Refractive outcomes', 'timeFrame': 'From preoperative visit to the final postoperative visit at twelve months', 'description': 'Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent'}, {'measure': 'Refractive predictability', 'timeFrame': 'From preoperative visit to the final postoperative visit at twelve months', 'description': 'Percentage of eyes within ± 0.25 D, ± 0.5 D, \\& ± 1.0 D'}, {'measure': 'Reduction in cylindrical power', 'timeFrame': 'From preoperative visit to the final postoperative visit at twelve months', 'description': 'The change in manifest refractive cylinder from baseline to the final postoperative visit.'}, {'measure': 'IOL Rotation', 'timeFrame': 'From preoperative visit to the final postoperative visit at twelve months', 'description': 'Percentage of IOLs with IOL rotation with less than 10 and 20 degrees.'}, {'measure': 'Stability of IOL axis orientation', 'timeFrame': 'Between 30 to 60 days and 120 to 180 days', 'description': 'Expressed as percentage of IOLs that rotate ≤ +/- 5 degrees postoperatively'}, {'measure': 'Axis Misalignment', 'timeFrame': 'From baseline to postoperative visit 120-180 days', 'description': 'The absolute difference between intended IOL axis orientation and measured IOL axis orientation with less than 10 and 20 degrees.'}, {'measure': 'Monocular Uncorrected Distance Visual Acuity (UDVA)', 'timeFrame': '12-Month Postoperative'}, {'measure': 'Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better', 'timeFrame': '12-Months Postoperatively'}, {'measure': 'Monocular Best-Corrected Distance Visual Acuity (CDVA)', 'timeFrame': '12-Months Postoperatively'}, {'measure': 'Monocular Uncorrected Intermediate Visual Acuity (UIVA)', 'timeFrame': '12-Months Postoperatively'}, {'measure': 'Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)', 'timeFrame': '12-Months Postoperatively'}, {'measure': 'Monocular (1st eye implantations) defocus curve', 'timeFrame': '12-Months Postoperatively'}, {'measure': 'Binocular defocus curve on subjects implanted binocularly', 'timeFrame': '12-Months Postoperatively'}, {'measure': 'Intraocular Pressure', 'timeFrame': '12-Months Postoperatively'}, {'measure': 'Assessment of subject satisfaction, patient reported outcomes, and spectacle independence', 'timeFrame': '12-Months Postoperatively'}, {'measure': 'IOL observations', 'timeFrame': '12-Months Postoperatively', 'description': 'IOL Decentration, Tilt, Discoloration, Opacity, Glistenings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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 / 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 / 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"}, 'identificationModule': {'nctId': 'NCT07471295', 'acronym': 'PACE', 'briefTitle': 'Toric Performance And Constant Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carl Zeiss Meditec AG'}, 'officialTitle': 'Prospective Assessment of Constant Optimization and Visual Outcomes Following Monofocal Toric IOL Implantation', 'orgStudyIdInfo': {'id': 'GPAS-SAS-026-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unilateral or bilateral implantation of investigational device', 'interventionNames': ['Device: Monofocal toric IOL']}], 'interventions': [{'name': 'Monofocal toric IOL', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Unilateral or bilateral implantation of investigational device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18100', 'city': 'Prague', 'state': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Petra Kasakova', 'role': 'CONTACT', 'email': 'kasakova@premiumclinic.cz', 'phone': '+420734579078'}, {'name': 'Jiří Pašta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oční klinikaO', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}, {'name': 'Andrea Janeková', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oční Centrum Praha', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT'}, {'name': 'Iveta Němcová', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ústřední vojenská nemocnice - Vojenská fakultní nemocnice Praha', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'contacts': [{'name': 'Raquel Amroussi', 'role': 'CONTACT', 'email': 'raquel.willrichamroussi@med.uni-heidelberg.de', 'phone': '+4966215636849'}, {'name': 'Gerd Auffarth', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '03001', 'city': 'Alicante', 'country': 'Spain', 'contacts': [{'name': 'José Rubio', 'role': 'CONTACT', 'email': 'jmrubio@oftalvist.es'}, {'name': 'Pedro Tañá', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ofatlivist Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': 'KA7 2SP', 'city': 'Ayr', 'state': 'Ayrshire', 'country': 'United Kingdom', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'info@ayrshireeyeclinic.com', 'phone': '+44 1292 282100'}, {'name': 'Satish Srinivasan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ayrshire Eye Clinic', 'geoPoint': {'lat': 55.46273, 'lon': -4.63393}}], 'centralContacts': [{'name': 'Grant Sharpe', 'role': 'CONTACT', 'email': 'grant.sharpe@zeiss.com', 'phone': '+447918937014'}, {'name': 'Linda Villanueva', 'role': 'CONTACT', 'email': 'linda.villanueva@zeiss.com', 'phone': '7143226506'}], 'overallOfficials': [{'name': 'Gerd Auffarth, Dr. Med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg'}, {'name': 'Andrea Janeková, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Centre Prague'}, {'name': 'Iveta Němcová, MD, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military University Hospital, Prague'}, {'name': 'Jiří Pašta, Doc.MUDr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premium Clinic'}, {'name': 'Satish Srinivasan, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ayrshire Eye Clinic'}, {'name': 'Pedro Tañá, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oftalmología Vistahermosa S.L'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Zeiss Meditec AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'targomedGmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}