Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT03949335
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2019-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-07-12', '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 Thomas, OD', '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': '6 months', 'description': 'Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes.\n\nThe total number of participants affected by SAE is total number of unique eyes. If an eye has multiple SAEs, the number of affected participant is one (1) but list multiple number of SAEs.\n\nOnly other (not including serious) adverse events that exceed the frequency threshold of 5% are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'ZFR00V First Eye', 'description': 'Study Lens', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 10, 'seriousNumAtRisk': 135, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'ZCB00 First Eye', 'description': 'Control Lens', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 0, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'ZFR00V Second Eye', 'description': 'Study Lens', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 135, 'otherNumAffected': 0, 'seriousNumAtRisk': 135, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'ZCB00 Second Eye', 'description': 'Control Lens', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 0, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Undesirable Optical Phenomena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cystoid Macular Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Undesirable Optical Phenomena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal Detachment/tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Macular Hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes Simplex Virus Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Toxic Anterior Segment Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Ulcers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypopyon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retained lens material resulting in secondary surgical intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Due to high blood pressure and high blood sugar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fractured right fibula and dislocated ankle requiring surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Exacerbation of congestive heart failure and atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Hernia requiring surgical repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Due to pneumonia due to influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 135, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZFR00V', 'description': 'Study Lens'}, {'id': 'OG001', 'title': 'ZCB00', 'description': 'Control Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.104', 'spread': '0.138', 'groupId': 'OG000'}, {'value': '0.522', 'spread': '0.193', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months (postoperative)', 'description': 'mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'The safety (SP) population for monocular Distance-Corrected Near Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)'}, {'type': 'SECONDARY', 'title': 'Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZFR00V', 'description': 'Study Lens'}, {'id': 'OG001', 'title': 'ZCB00', 'description': 'Control Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.060', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '0.335', 'spread': '0.155', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months (postoperative)', 'description': 'mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'The safety (SP) population for monocular Distance-Corrected Intermediate Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)'}, {'type': 'SECONDARY', 'title': 'Monocular Distance-Corrected Near Visual Acuity at 33 cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZFR00V', 'description': 'Study Lens'}, {'id': 'OG001', 'title': 'ZCB00', 'description': 'Control Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '0.154', 'spread': '0.151', 'groupId': 'OG000'}, {'value': '0.608', 'spread': '0.187', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months postoperative', 'description': 'mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'The safety (SP) population for monocular Distance-Corrected Near Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)'}, {'type': 'SECONDARY', 'title': 'Monocular Photopic Best-Corrected Distance Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZFR00V', 'description': 'Study Lens'}, {'id': 'OG001', 'title': 'ZCB00', 'description': 'Control Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.014', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '-0.045', 'spread': '0.089', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.031', 'ciLowerLimit': '-0.053', 'ciUpperLimit': '-0.010', 'pValueComment': 'Success criteria was evaluated using lower confidence interval. No P-Value was calculated.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Noninferiority margin equals -0.1'}], 'paramType': 'MEAN', 'timeFrame': '6 months postoperative', 'description': 'mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'The safety (SP) population for monocular Best-Corrected Distance Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)'}, {'type': 'SECONDARY', 'title': 'Monocular Distance-Corrected Defocus Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZFR00V', 'description': 'Study Lens'}, {'id': 'OG001', 'title': 'ZCB00', 'description': 'Control Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'groupId': 'OG000', 'lowerLimit': '-3.6', 'upperLimit': '-3.0'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-1.1', 'upperLimit': '-0.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months postoperative', 'description': 'Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population', 'unitOfMeasure': 'diopter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'The safety (SP) population for monocular Distance-Corrected Defocus Curve include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)'}, {'type': 'SECONDARY', 'title': 'Spectacle Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ZFR00V', 'description': 'Study Lens'}, {'id': 'OG001', 'title': 'ZCB00', 'description': 'Control Lens'}], 'classes': [{'title': 'None of the time', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'A little/Some/Most/All of the time', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months postoperative', 'description': 'Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts "none of the time" in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety (SP) population for spectacle independence include all subjects implanted bilaterally with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ZFR00V', 'description': 'Study Lens'}, {'id': 'FG001', 'title': 'ZCB00', 'description': 'Control Lens'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': '272 subjects were bilaterally implanted with either the study or control lens. 135 subjects were bilaterally implanted with the study lens and 137 subjects were bilaterally implanted with the control lens. All 272 subjects were bilaterally implanted with the same IOL model in both eyes.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ZFR00V', 'description': 'Study Lens'}, {'id': 'BG001', 'title': 'ZCB00', 'description': 'Control Lens'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<60', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': '60 to 69', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}, {'title': '70 to 79', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': '> or = 80', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian (including Indian)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}, {'title': 'Other Race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-12', 'size': 1300543, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-16T06:49', 'hasProtocol': True}, {'date': '2020-05-12', 'size': 409873, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-16T06:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only the surgeon and the operative staff will know which lens type is implanted and will be unmasked throughout the study. There may also be site coordinators and other site study staff, such as those performing slit-lamp exams, who will be unmasked. Unmasked study staff and study subjects will be instructed not to disclose the lens type the subject received or to talk about the lens to any subjects or masked evaluators.\n\nThe subjects and the study technicians performing the postoperative vision tests are to be masked through study completion. To maintain subject/technician-masking through the 6-month study exams, a masking plan will be tailored for each site to detail how lens assignment information will be concealed from masked technicians.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2019-05-01', 'resultsFirstSubmitDate': '2021-06-16', 'studyFirstSubmitQcDate': '2019-05-13', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-03', 'studyFirstPostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm', 'timeFrame': '6 months (postoperative)', 'description': 'mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months'}], 'secondaryOutcomes': [{'measure': 'Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm', 'timeFrame': '6 months (postoperative)', 'description': 'mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population'}, {'measure': 'Monocular Distance-Corrected Near Visual Acuity at 33 cm', 'timeFrame': '6 months postoperative', 'description': 'mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months'}, {'measure': 'Monocular Photopic Best-Corrected Distance Visual Acuity', 'timeFrame': '6 months postoperative', 'description': 'mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.'}, {'measure': 'Monocular Distance-Corrected Defocus Curve', 'timeFrame': '6 months postoperative', 'description': 'Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population'}, {'measure': 'Spectacle Wear', 'timeFrame': '6 months postoperative', 'description': 'Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts "none of the time" in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract', 'Corneal Astigmatism']}, 'referencesModule': {'references': [{'pmid': '37097283', 'type': 'DERIVED', 'citation': 'Chang DH, Hu JG, Lehmann RP, Thompson VM, Tsai LH, Thomas EK. Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial. J Cataract Refract Surg. 2023 Aug 1;49(8):840-847. doi: 10.1097/j.jcrs.0000000000001205.'}]}, 'descriptionModule': {'briefSummary': 'This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization.\n\nAfter signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be at least 22 years old\n* have cataracts in both eyes\n* sign the written informed consent\n* be willing and able to comply with examination procedures\n* understand, read and write English to complete informed consent and questionnaires\n* be available for study follow-up visits\n\nExclusion Criteria:\n\n* currently participating in any other clinical study or have participated in a clinical study during the last 60 days\n* have a certain disease/illness such as poorly-controlled diabetes\n* have certain ocular conditions such as uncontrolled glaucoma\n* Is taking medication that may affect vision\n* Subject is pregnant, plan to become pregnant during the study, or is breastfeeding'}, 'identificationModule': {'nctId': 'NCT03949335', 'acronym': 'BRAVO', 'briefTitle': 'Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Surgical Vision, Inc.'}, 'officialTitle': 'Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens', 'orgStudyIdInfo': {'id': 'SUR-CAT-652-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational', 'description': 'Bilateral implantation with investigational IOL Model ZFR00V', 'interventionNames': ['Device: IOL Model ZFR00V']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Bilateral implantation with control IOL Model ZCB00', 'interventionNames': ['Device: IOL Model ZCB00']}], 'interventions': [{'name': 'IOL Model ZFR00V', 'type': 'DEVICE', 'description': 'Bilateral implantation with Investigational IOL Model ZFR00V', 'armGroupLabels': ['Investigational']}, {'name': 'IOL Model ZCB00', 'type': 'DEVICE', 'description': 'Bilateral Implantation with control IOL Model ZCB00', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Empire Eye & Laser Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Wolstan & Goldberg Eye Associates', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Katzen Eye Care & Laser Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'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 & Laser Center', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '45242', 'city': 'Blue Ash', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.232, 'lon': -84.37827}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scott & Christie and Associates, PC', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina EyeCare Physicians', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '75243', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Key-Whitman Eye Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Berkeley Eye Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Eye and Laser Center', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}, {'zip': '75965', 'city': 'Nacogdoches', 'state': 'Texas', 'country': 'United States', 'facility': 'Lehmann Eye Center', 'geoPoint': {'lat': 31.60351, 'lon': -94.65549}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Focal Point Vision', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98503', 'city': 'Lacey', 'state': 'Washington', 'country': 'United States', 'facility': 'Clarus Eye Centre', '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 Device 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'}}}}