Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT04210232
Status:
COMPLETED
Last Update Posted:
2021-10-12
First Post:
2019-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'EThoma39@its.jnj.com', 'phone': '+1 657 2903260', 'title': 'Eugenia K. Thomas', 'organization': 'Johnson & Johnson Surgical Vision'}, 'certainAgreement': {'otherDetails': 'The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '3 months postoperative', 'eventGroups': [{'id': 'EG000', 'title': 'TECNIS Toric II', 'description': 'Study Lens', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Hospitalization due to bleeding varices', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to heart attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystoid Macular Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to vomiting of blood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TECNIS Toric II', 'description': 'Study Lens'}], 'classes': [{'title': 'Very Satisfied/Satisfied', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.8', 'upperLimit': '100'}]}]}, {'title': 'Undecided/Dissatisfied/Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months postoperative', 'description': 'Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).', 'unitOfMeasure': 'Percentage of eyes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All Toric II Eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TECNIS Toric II', 'description': 'Study Lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '87 subjects signed informed consent in the study. 33 were screen failures and 54 subjects were treated/implanted across 8 clinical sites in the US. Of the 54 subjects treated, 32 subjects were treated bilaterally, and 22 subjects were treated unilaterally.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TECNIS Toric II', 'description': 'Study Lens'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<60 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}, {'title': '>=80 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Native hawaiian/Pacific islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-20', 'size': 1153787, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-02T13:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2019-12-23', 'resultsFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-07', 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II', 'timeFrame': '3 months postoperative', 'description': 'Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract', 'Corneal Astigmatism']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned;\n2. Preoperative corneal astigmatism of one diopter or more in the operative eye;\n3. Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better;\n4. Clear intraocular media other than cataract in each eye;\n5. Ability to understand, read and write English in order to consent to study participation;\n6. Availability, willingness, sufficient cognitive awareness to comply with examination procedures;\n7. Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization.\n\nExclusion Criteria:\n\n1. Recurrent severe anterior or posterior segment inflammation or uveitis;\n2. Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible;\n3. Circumstances that would result in damage to the endothelium during implantation;\n4. Suspected ocular microbial infection;\n5. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;\n6. Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, \\[macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.\\];\n7. Planned monovision correction;\n8. Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.'}, 'identificationModule': {'nctId': 'NCT04210232', 'briefTitle': 'Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Surgical Vision, Inc.'}, 'officialTitle': 'Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)', 'orgStudyIdInfo': {'id': 'NXGT-201-TTL2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TECNIS® TORIC II Intraocular Lens (IOL)', 'description': 'Subjects will be implanted with the TECNIS Toric II IOL in one or both eyes qualified for study inclusion', 'interventionNames': ['Device: TECNIS® TORIC II Intraocular Lens (IOL)']}], 'interventions': [{'name': 'TECNIS® TORIC II Intraocular Lens (IOL)', 'type': 'DEVICE', 'description': 'Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.', 'armGroupLabels': ['TECNIS® TORIC II Intraocular Lens (IOL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Empire Eye & Laser Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Jones Eye Clinic', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Eye Care and Laser Center', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Eye Doctors of Washington', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '48009', 'city': 'Birmingham', 'state': 'Michigan', 'country': 'United States', 'facility': 'Oakland Ophthalmic Surgery, P.C.', 'geoPoint': {'lat': 42.5467, 'lon': -83.21132}}, {'zip': '63109', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Tekwani Vision Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '29456', 'city': 'Ladson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Cataract & Laser Center', 'geoPoint': {'lat': 32.98573, 'lon': -80.10981}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Key & Whitman Eye Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Eye and Laser Center', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkhurst NuVision', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98503', 'city': 'Lacey', 'state': 'Washington', 'country': 'United States', 'facility': 'Clarus Eye Center', 'geoPoint': {'lat': 47.03426, 'lon': -122.82319}}], 'overallOfficials': [{'name': 'Johnson & Johnson Surgical Vision Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Surgical Vision'}]}, 'ipdSharingStatementModule': {'url': 'http://yoda.yale.edu', 'ipdSharing': 'YES', 'description': 'Johnson \\& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Surgical Vision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}