Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT03111550
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2017-04-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Investigation of the Next-Generation Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'djanaki1@its.jnj.com', 'phone': '+1 714-247-8628', 'title': 'Devi Priya Janakiraman,OD, FAAO', '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': 'The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group.\n\nOne subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.', 'eventGroups': [{'id': 'EG000', 'title': 'Tecnis ZHR00', 'description': 'Investigational Lens Device', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 4, 'seriousNumAtRisk': 78, 'deathsNumAffected': 2, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'ZQR00', 'description': 'Investigational Lens Device', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 3, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'ZXR00', 'description': 'Control Lens Device', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 3, 'seriousNumAtRisk': 79, 'deathsNumAffected': 1, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'ADE, Bothersome visual symptoms causing significant impairment lasting more than 3 mos postop', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Retinal tear and repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Clot in leg requiring emergency angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary Surgical Intervention: IOL removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystoid Macular Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hernia Surgical repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis of Large intestine with perforation resulting in hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lens removal due to undesired optical phenomena due to fixed pupil', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death during sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to surgical removal of tumors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death secondary to cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to weakness secondary to cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to hip fracture secondary to fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}, {'units': 'Eyes', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tecnis ZHR00', 'description': 'Investigational Lens Device'}, {'id': 'OG001', 'title': 'Tecnis ZQR00', 'description': 'Investigational Lens Device'}, {'id': 'OG002', 'title': 'Tecnis ZXR00', 'description': 'Control Lens Device'}], 'classes': [{'categories': [{'measurements': [{'value': '0.136', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '0.141', 'spread': '0.149', 'groupId': 'OG001'}, {'value': '0.276', 'spread': '0.116', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month postoperative', 'description': 'The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'The safety population (SP) of all subjects implanted who have available data will be used for all analysis. For the monocular endpoints, the safety population will consist of first eyes implanted with a study IOL.'}, {'type': 'PRIMARY', 'title': 'Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tecnis ZHR00', 'description': 'Investigational Lens Device'}, {'id': 'OG001', 'title': 'Tecnis ZQR00', 'description': 'Investigational Lens Device'}, {'id': 'OG002', 'title': 'Tecnis ZXR00', 'description': 'Control Lens Device'}], 'classes': [{'title': 'Corneal edema', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Cystoid macular edema', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Iritis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Raised IOP requiring treatment', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.02041', 'groupIds': ['OG002'], 'ciNumSides': 'ONE_SIDED', 'statisticalMethod': 'Exact test on binomial distribution', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for corneal edema)'}], 'paramType': 'NUMBER', 'timeFrame': '6 months postoperative', 'description': 'Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution.\n\nISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).\n\nISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.\n\nSPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US).\n\nOnly AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical comparisons to ISO SPE rates are based on first-eye data'}, {'type': 'PRIMARY', 'title': 'Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tecnis ZHR00', 'description': 'Investigational Lens Device'}, {'id': 'OG001', 'title': 'Tecnis ZQR00', 'description': 'Investigational Lens Device'}, {'id': 'OG002', 'title': 'Tecnis ZXR00', 'description': 'Control Lens Device'}], 'classes': [{'title': 'Cystoid Macular Edema', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'Hypopyon', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Endolphthalmitis', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Lens dislocated from posterior chamber', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Pupillary block', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Retinal detachment', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': 'Eyes with secondary surgical intervention', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1969', 'groupIds': ['OG001'], 'ciNumSides': 'ONE_SIDED', 'pValueComment': 'For ZQR00 retinal detachment', 'statisticalMethod': 'Exact test on binomial distribution', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Compare if study AE rate is significantly higher than ISO SPE rate (0.3% for retinal detachment)'}, {'pValue': '0.4655', 'groupIds': ['OG000'], 'ciNumSides': 'ONE_SIDED', 'pValueComment': 'For ZHR00 secondary surgical intervention', 'statisticalMethod': 'Exact test of binomial distribution', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)'}, {'pValue': '0.0210', 'groupIds': ['OG001'], 'ciNumSides': 'ONE_SIDED', 'pValueComment': 'For ZQR00 secondary surgical intention', 'statisticalMethod': 'Exact test on binomial distribution', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)'}, {'pValue': '0.4698', 'groupIds': ['OG002'], 'ciNumSides': 'ONE_SIDED', 'pValueComment': 'For ZXR00 secondary surgical intervention', 'statisticalMethod': 'Exact test on binomial distribution', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Compare if study AE rate is significantly higher than ISO SPE rate (0.8% for secondary surgical intervention)'}], 'paramType': 'NUMBER', 'timeFrame': '6 months postoperative', 'description': 'Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution.\n\nOnly AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical comparisons to ISO SPE rates are based on first-eye data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tecnis ZHR00', 'description': 'Investigational Lens Device'}, {'id': 'FG001', 'title': 'Tecnis ZQR00', 'description': 'Investigational Lens Device'}, {'id': 'FG002', 'title': 'Tecnis ZXR00', 'description': 'Control Lens Device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'First eye', 'groupId': 'FG000', 'numSubjects': '77'}, {'comment': 'First eye', 'groupId': 'FG001', 'numSubjects': '73'}, {'comment': 'First eye', 'groupId': 'FG002', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 242 subjects were enrolled in this study, and 229 subjects were implanted with study IOL in first eye.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tecnis ZHR00', 'description': 'Investigational Lens Device'}, {'id': 'BG001', 'title': 'Tecnis ZQR00', 'description': 'Investigational Lens Device'}, {'id': 'BG002', 'title': 'Tecnis ZXR00', 'description': 'Control Lens Device'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Les than < 60 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}, {'title': 'Greater than or equal to >= 80 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian (including Indian)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian/Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}]}, {'title': 'Other race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-24', 'size': 1484270, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-06T11:26', 'hasProtocol': True}, {'date': '2017-02-24', 'size': 930834, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-06T11:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'subject/evaluator-masked'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'dispFirstSubmitDate': '2019-02-11', 'completionDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2017-04-07', 'dispFirstSubmitQcDate': '2020-08-07', 'resultsFirstSubmitDate': '2020-07-06', 'studyFirstSubmitQcDate': '2017-04-07', 'dispFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-07', 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm', 'timeFrame': '1 month postoperative', 'description': 'The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative'}, {'measure': 'Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)', 'timeFrame': '6 months postoperative', 'description': 'Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution.\n\nISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).\n\nISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.\n\nSPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US).\n\nOnly AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.'}, {'measure': 'Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates)', 'timeFrame': '6 months postoperative', 'description': 'Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution.\n\nOnly AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL.\n\nThe study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral cataracts\n* Potential for postoperative BCDVA of 20/30 Snellen or better\n* Corneal astigmatism of 1.00 D or less in both eyes\n* Normal corneal topography\n* Clear intraocular media other than cataract in each eye\n* Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries\n\nExclusion Criteria:\n\n* Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)\n* Irregular corneal astigmatism\n* Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)\n* Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery\n* Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study\n* Inability to achieve keratometric stability for contact lens wearers\n* Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject\n* Subjects with diagnosed degenerative visual disorders\n* Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects\n* Use of systemic or ocular medications that may affect vision\n* Prior, current, or anticipated use of tamsulosin or silodosin\n* Poorly-controlled diabetes\n* Acute, chronic, or uncontrolled systemic or ocular disease or illness\n* Known ocular disease or pathology that may affect visual acuity or may require surgical intervention during the course of the study or may be expected to require retinal laser treatment or other surgical intervention during the course of the study\n* 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\n* Concurrent participation or participation within 45 days prior to preoperative visit in any other clinical trial\n* Desire for monovision correction'}, 'identificationModule': {'nctId': 'NCT03111550', 'briefTitle': 'Clinical Investigation of the Next-Generation Intraocular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Optics'}, 'officialTitle': 'Clinical Investigation of the TECNIS Next-Generation Intraocular Lens', 'orgStudyIdInfo': {'id': 'EDOF-121-NGPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Investigational Lens Device #1', 'description': 'Investigational Intraocular Lens Device #1: Tecnis Model ZHR00', 'interventionNames': ['Device: Investigational Intraocular Lens Device #1: TECNIS Model ZHR00']}, {'type': 'OTHER', 'label': 'Investigational Lens Device #2', 'description': 'Investigational Intraocular Lens Device #2: Tecnis Model ZQR00', 'interventionNames': ['Device: Investigational Intraocular Lens Device #2: TECNIS Model ZQR00']}, {'type': 'OTHER', 'label': 'Control Device', 'description': 'Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00', 'interventionNames': ['Device: TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00']}], 'interventions': [{'name': 'Investigational Intraocular Lens Device #1: TECNIS Model ZHR00', 'type': 'DEVICE', 'description': 'Intraocular lens replaces the natural lens removed during cataract surgery.', 'armGroupLabels': ['Investigational Lens Device #1']}, {'name': 'Investigational Intraocular Lens Device #2: TECNIS Model ZQR00', 'type': 'DEVICE', 'description': 'Intraocular lens replaces the natural lens removed during cataract surgery.', 'armGroupLabels': ['Investigational Lens Device #2']}, {'name': 'TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00', 'type': 'DEVICE', 'description': 'Intraocular lens replaces the natural lens removed during cataract surgery.', 'armGroupLabels': ['Control Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Empire Eye and Laser Center', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Assil Eye Institute', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Jones Eye Care', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Eye Care and Laser', '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': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Consultants LTD', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scott and Christie and Associates,PC', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '29456', 'city': 'Ladson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Cataract and Laser Center', 'geoPoint': {'lat': 32.98573, 'lon': -80.10981}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37072', 'city': 'Goodlettsville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Loden Vision Centers', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'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}}], 'overallOfficials': [{'name': 'Devi Priya Janakiraman, OD,FAAO', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Medical Optics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Optics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}