Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-02 @ 2:04 PM
Study NCT ID:
NCT05210569
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2022-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Visual Outcomes of Vivity in Patients With High Axial Length
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamesjwiens@gmail.com', 'phone': '1-204-943-6287', 'title': 'Dr James Wiens', 'organization': 'Image Plus Laser Eye Centre'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months postoperatively', 'eventGroups': [{'id': 'EG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Binocular Uncorrected Distance Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Binocular uncorrected distance visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Uncorrected Intermediate Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Binocular uncorrected intermediate visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Binocular Uncorrected Near Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '0.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Binocular uncorrected near visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prediction Error', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '3 months postoperatively', 'description': 'Percentage of eyes with absolute prediction error of 0.5D or less', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Binocular Corrected Distance Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Binocular corrected distance visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Distance Corrected Intermediate Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Binocular distance corrected intermediate visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Distance Corrected Near Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'spread': '0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Binocular distance corrected near visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Monocular Corrected Distance Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Monocular corrected distance visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Monocular Distance Corrected Intermediate Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Monocular distance corrected intermediate visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Monocular Distance Corrected Near Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'spread': '0.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Monocular distance corrected near visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Manifest Refraction Spherical Equivalent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'spread': '0.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Manifest refraction spherical equivalent', 'unitOfMeasure': 'diopter (D)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}, {'type': 'SECONDARY', 'title': 'Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'title': '"Bothered quite a bit" or "Bothered very much" by starbursts', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '"Bothered quite a bit" or "Bothered very much" by halos', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '"Bothered quite a bit" or "Bothered very much" by glare', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '"Bothered quite a bit" or "Bothered very much" by haze', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '"Bothered quite a bit" or "Bothered very much" by blurred vision', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '"Bothered quite a bit" or "Bothered very much" by double vision', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '"Bothered quite a bit" or "Bothered very much" by dark area', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months postoperatively', 'description': 'Questionnaire for visual disturbance scores (QUVID)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Spectacle Independence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'title': 'Spectacle independence distance (overall)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Spectcle independence intermediate (overall)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Spectacle independence near (overall)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months postoperatively', 'description': 'Binocular distance-corrected low contrast distance visual acuity (logMAR)', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '40', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '40', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bilateral Implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)\n\nVivity: Vivity intraocular lens (IOL)'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '6.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'typeUnitsAnalyzed': 'Eyes'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-11', 'size': 364903, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-28T09:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2022-01-13', 'resultsFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-15', 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binocular Uncorrected Distance Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Binocular uncorrected distance visual acuity (logMAR)'}, {'measure': 'Binocular Uncorrected Intermediate Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Binocular uncorrected intermediate visual acuity (logMAR)'}, {'measure': 'Binocular Uncorrected Near Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Binocular uncorrected near visual acuity (logMAR)'}], 'secondaryOutcomes': [{'measure': 'Prediction Error', 'timeFrame': '3 months postoperatively', 'description': 'Percentage of eyes with absolute prediction error of 0.5D or less'}, {'measure': 'Binocular Corrected Distance Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Binocular corrected distance visual acuity (logMAR)'}, {'measure': 'Binocular Distance Corrected Intermediate Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Binocular distance corrected intermediate visual acuity (logMAR)'}, {'measure': 'Binocular Distance Corrected Near Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Binocular distance corrected near visual acuity (logMAR)'}, {'measure': 'Monocular Corrected Distance Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Monocular corrected distance visual acuity (logMAR)'}, {'measure': 'Monocular Distance Corrected Intermediate Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Monocular distance corrected intermediate visual acuity (logMAR)'}, {'measure': 'Monocular Distance Corrected Near Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Monocular distance corrected near visual acuity (logMAR)'}, {'measure': 'Manifest Refraction Spherical Equivalent', 'timeFrame': '3 months postoperatively', 'description': 'Manifest refraction spherical equivalent'}, {'measure': 'Questionnaire', 'timeFrame': '3 months postoperatively', 'description': 'Questionnaire for visual disturbance scores (QUVID)'}, {'measure': 'Percentage of Participants With Spectacle Independence', 'timeFrame': '3 months', 'description': 'The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.'}, {'measure': 'Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)', 'timeFrame': '3 months postoperatively', 'description': 'Binocular distance-corrected low contrast distance visual acuity (logMAR)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['EDOF IOL Vivity'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.', 'detailedDescription': 'This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.', 'eligibilityCriteria': "Subjects are eligible for the study if they meet the following criteria:\n\nNote: Ocular criteria must be met in both eyes.\n\nInclusion Criteria:\n\n* Undergoing uncomplicated bilateral cataract surgery with IOL implantation.\n* Gender: Males and Females.\n* Age: 50 years or older.\n* Willing and able to provide written informed consent for participation in the study.\n* Willing and able to comply with scheduled visits and other study procedures.\n* Motivated for greater degree of spectacle independence vs monofocal IOL.\n* Axial length ≥24.5mm in both eyes.\n* Planned cataract removal by femtosecond laser.\n\nExclusion Criteria:\n\nIf any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.\n\n* Ocular comorbidity that might hamper postoperative visual acuity.\n* Previous refractive surgery.\n* Irregular corneal astigmatism.\n* Evidence of keratoconus as per Pentacam.\n* Expected post-op VA worse than 20/25 (Snellen).\n* Refractive lens exchange.\n* Difficulties comprehending written or spoken English language.\n* Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).\n* Clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion.\n* Axial length \\<24.5mm.\n* Evidence of macular pathology as per optical coherence tomography examination.\n\nThe principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.\n\nPregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness."}, 'identificationModule': {'nctId': 'NCT05210569', 'briefTitle': 'Visual Outcomes of Vivity in Patients With High Axial Length', 'organization': {'class': 'OTHER', 'fullName': 'Dr. James J. Wiens Medical Corporation'}, 'officialTitle': 'Visual Outcomes of the AcrySof® Vivity Intraocular Lens in Patients With High Ocular Axial Length', 'orgStudyIdInfo': {'id': 'JW-21-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bilateral implantation of the Vivity IOL', 'description': 'Vivity intraocular lens (IOL)', 'interventionNames': ['Device: Vivity']}], 'interventions': [{'name': 'Vivity', 'type': 'DEVICE', 'description': 'Vivity intraocular lens (IOL)', 'armGroupLabels': ['Bilateral implantation of the Vivity IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3C4K5', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Image Plus Laser Eye Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'James J Wiens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. James J. Wiens Medical Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. James J. Wiens Medical Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sengi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}