Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-31 @ 7:41 PM
Study NCT ID:
NCT01230060
Status:
COMPLETED
Last Update Posted:
2013-08-22
First Post:
2010-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001035', 'term': 'Aphakia'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jon.hayashida@bausch.com', 'phone': '(949) 521-7876', 'title': 'Jon Hayashida', 'organization': 'Bausch & Lomb Incorporated'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '140-180 days', 'eventGroups': [{'id': 'EG000', 'title': 'enVista', 'description': 'enVista One-Piece Hydrophobic Acrylic Intraocular Lens\n\nenVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.', 'otherNumAtRisk': 122, 'otherNumAffected': 0, 'seriousNumAtRisk': 122, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Acute myeloid leukemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 122, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'enVista', 'description': 'enVista One-Piece Hydrophobic Acrylic Intraocular Lens\n\nenVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '120-180 days (visit 4)', 'description': 'Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All non missing implanted eyes, consistent set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'enVista', 'description': 'enVista One-Piece Hydrophobic Acrylic Intraocular Lens\n\nenVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 6 clinical sites in the US. Study started Aug 2010 and was completed June 2011.', 'preAssignmentDetails': '122 subjects underwent cataract extraction and implantation of the Bausch + Lomb Intraocular Lens (IOL) for the correction of aphakia.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'enVista', 'description': 'enVista One-Piece Hydrophobic Acrylic Intraocular Lens\n\nenVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'spread': '8.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All implanted eyes'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-09', 'studyFirstSubmitDate': '2010-10-27', 'resultsFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2010-10-27', 'lastUpdatePostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-09', 'studyFirstPostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '120-180 days (visit 4)', 'description': 'Number of participants achieving best corrected visual acuity (BCVA) of 20/40 or better following cataract extraction and intraocular lens implantation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ocular surgery', 'phacoemulsification'], 'conditions': ['Aphakia', 'Cataract']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and effectiveness of the enVista® One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens has been removed by an extracapsular cataract extraction method (eg, small incision phacoemulsification).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.\n* Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40 in the study eye, with or without a glare source.\n* Subjects must have a BCVA projected to be better than 20/30 after IOL implantation in the study eye.\n\nExclusion Criteria:\n\n* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.\n* Subjects with any other serious ocular pathology, or underlying serious medical conditions, which based on the Investigator's medical judgment, could confound the results of the study."}, 'identificationModule': {'nctId': 'NCT01230060', 'briefTitle': 'One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of a Bausch + Lomb One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction', 'orgStudyIdInfo': {'id': '658'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'enVista', 'description': 'enVista One-Piece Hydrophobic Acrylic Intraocular Lens', 'interventionNames': ['Device: enVista']}], 'interventions': [{'name': 'enVista', 'type': 'DEVICE', 'description': 'One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.', 'armGroupLabels': ['enVista']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92656', 'city': 'Aliso Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 33.56504, 'lon': -117.72712}}], 'overallOfficials': [{'name': 'Mark Packer, MD,FACS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Drs. Fine, Hoffman & Packer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}