Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT04327518
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2020-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the Rotational Stability of the Tecnis Toric II IOL
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-26', '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': '7142478200', 'title': 'Director of Clinical Science, Ophthalmic Implants', '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', 'eventGroups': [{'id': 'EG000', 'title': 'Tecnis Toric II IOL', 'description': 'Study lens', 'otherNumAtRisk': 125, 'deathsNumAtRisk': 125, 'otherNumAffected': 0, 'seriousNumAtRisk': 125, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystoid Macular Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Bilateral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyphema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic Choroidal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tecnis Toric II IOL', 'description': 'Study lens'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week postoperative', 'description': 'Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method.', 'unitOfMeasure': 'Percentage of Eyes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'All Toric II Eyes with Valid Axis Data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tecnis Toric II IOl', 'description': 'Study Lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '202', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '200', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'preAssignmentDetails': 'A total of 125 subjects were enrolled. A total of 202 eyes were implanted with the TECNIS Toric II IOL in at least one eye: 80 subjects were treated bilaterally (77 subjects with study lens on both eyes, 3 subjects with non-study lens on first eye and study lens on second eye) and 45 subjects were treated unilaterally. All implanted subjects were examined through 3-months postoperatively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tecnis Toric II IOL', 'description': 'Study lens'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<60 years', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': '>+80 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '118', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-10', 'size': 1711978, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-05T13:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2020-03-27', 'resultsFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2020-03-27', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-05', 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit', 'timeFrame': '1 week postoperative', 'description': 'Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract', 'Corneal Astigmatism']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Minimum 22 years of age;\n2. Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned;\n3. Pre-existing corneal astigmatism of one diopter or greater;\n4. Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D;\n5. Potential for postoperative BCDVA of 20/30 Snellen or better;\n6. Clear intraocular media other than cataract in each eye;\n7. Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits;\n8. Signed informed consent form (ICF) and health insurance portability and accountability act (HIPAA) authorization;\n9. Ability to understand and respond to a questionnaire in English.\n\nExclusion Criteria:\n\n1. Irregular corneal astigmatism;\n2. Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear;\n3. Previous corneal or intraocular surgery;\n4. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);\n5. Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils);\n6. Dilated pupil size of \\< 6.0 mm;\n7. Recurrent severe anterior or posterior segment inflammation or uveitis;\n8. 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;\n9. Known ocular or systemic disease 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.\\];\n10. Use of systemic or ocular medications (e.g., Flomax) that may affect vision including prior, current, or anticipated use during the course of the study that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);\n11. Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes;\n12. Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.\n13. Planned monovision correction (eye designated for near correction)'}, 'identificationModule': {'nctId': 'NCT04327518', 'acronym': 'STEELE', 'briefTitle': 'Evaluation of the Rotational Stability of the Tecnis Toric II IOL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Surgical Vision, Inc.'}, 'officialTitle': 'Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens', 'orgStudyIdInfo': {'id': 'NXGT-202-QROS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TECNIS® Toric II', 'description': 'Subjects will be implanted in one or both eyes with the study lens', 'interventionNames': ['Device: TECNIS® Toric II']}], 'interventions': [{'name': 'TECNIS® Toric II', 'type': 'DEVICE', 'description': 'Toric Intraocular Lens', 'armGroupLabels': ['TECNIS® Toric II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Empire Eye and Laser Center, Inc.', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92705', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Jones Eye Clinic', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '58078', 'city': 'West Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision, ND', 'geoPoint': {'lat': 46.87497, 'lon': -96.90036}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'JW Eye Associates, P.A. DBA Key-Whitman Eye Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Eye & Laser Center, P.A.', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}], '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'}}}}