Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 8:15 PM
Study NCT ID:
NCT05464732
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vivity IOL: Emmetropia Compared to Monovision.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hps@cepmd.com', 'phone': '8438813937', 'title': 'Director of Clinical Trials', 'organization': 'Carolina Eyecare Physicians, LLC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'AE were collected from the time the ICF was signed to the exit visit at 3 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Monovision', 'description': 'The target refraction is plano (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. The Vivity IOL will be implanted bilaterally.\n\nCorrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.\n\nVivity IOL: The Vivity IOL will be implanted bilaterally in all subjects.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Emmetropia', 'description': "Subject's vision will be tested with both eyes corrected for emmetropia.\n\nVivity IOL: The Vivity IOL will be implanted bilaterally in all subjects.", 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Binocular Uncorrected Near (40 cm) Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Monovision', 'description': 'The target refraction is plano (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. The Vivity IOL will be implanted bilaterally.\n\nCorrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.\n\nVivity IOL: The Vivity IOL will be implanted bilaterally in all subjects.'}, {'id': 'OG001', 'title': 'Emmetropia', 'description': "Subject's vision will be tested with both eyes corrected for emmetropia.\n\nVivity IOL: The Vivity IOL will be implanted bilaterally in all subjects."}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The logMAR binocular uncorrected visual acuity at 40 cm will be measured.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Monovision Then Emmetropia', 'description': 'All study participants received the Vivity IOL in both eyes.\n\n1. Target refraction plano (emmetropia): the target was (0.00 D) for both the dominant and the non-dominant eye. Corrected vision will involve correcting both eyes for plano.\n2. Target refraction monovision where the target was (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.'}, {'id': 'FG001', 'title': 'Emmetropia Then Monovision', 'description': 'All study participants received the Vivity IOL in both eyes.\n\n1. Target refraction plano (emmetropia): the target was (0.00 D) for both the dominant and the non-dominant eye. Corrected vision will involve correcting both eyes for plano.\n2. Target refraction monovision where the target was (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 33 subjects were enrolled in the study. One was lost to follow up and one experienced a progression of their macular degeneration, leaving 31 subjects for analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall', 'description': 'All study participants received the Vivity IOL in both eyes.\n\nThe same group of participants were evaluated twice using two different target refractions:\n\n1. Target refraction plano: the target was (0.00 D) for both the dominant and the non-dominant eye. Corrected vision will involve correcting both eyes for plano.\n2. Target refraction monovision where the target was (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. Corrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.\n\nParticipants were randomized to which target was evaluated first and there was a 10 minutes break between the 2 evaluations.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'spread': '5.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-15', 'size': 172177, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-13T17:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients all had same treatment, evaluated postoperatively in two scenarios.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2022-07-18', 'resultsFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2022-07-18', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-19', 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binocular Uncorrected Near (40 cm) Visual Acuity', 'timeFrame': '3 months', 'description': 'The logMAR binocular uncorrected visual acuity at 40 cm will be measured.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Presbyopia']}, 'descriptionModule': {'briefSummary': 'Current visual outcomes expectations of cataract patients are similar to those of refractive surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision activities. Different options are available including: mono-vision and presbyopia correcting intraocular lenses (IOL). Presbyopia correcting IOLs include accommodative, multifocal, trifocal and extended depth of focus (EDOF) IOLs. The Vivity Extended Vision IOL is not a multifocal IOL but due to its design, it provides better intermediate and near VA compared to a monofocal IOL.', 'detailedDescription': 'The study is concerned with the visual performance of the Vivity Extended Vision IOL at distance, intermediate and near when one of the eyes is targeted for emmetropia and the other is targeted for slight myopia. Patients will serve as their own controls with visual performance evaluated against corrected vision with a target of emmetropia in both eyes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must fulfill the following conditions to qualify for enrollment into the trial\n\n1. Subject is undergoing bilateral lens extraction with intraocular lens implantation.\n2. Gender: Males and Females.\n3. Age: 50 years and older.\n4. Willing and able to provide written informed consent for participation in the study\n5. Willing and able to comply with scheduled visits and other study procedures.\n6. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6 to 30 days between surgeries\n7. Subjects who require an IOL power in the range of +15.0 D to +25.0 D only.\n8. Subjects who require a toric IOL up to +3.00 D at the IOL plane (2.06 D corneal plane).\n9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions on the eligibility exam may not be enrolled into the trial.\n\n1. Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.\n2. Uncontrolled diabetes.\n3. Use of any systemic or topical drug known to interfere with visual performance.\n4. Contact lens use during the active treatment portion of the trial.\n5. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.\n6. Clinically significant corneal dystrophy\n7. History of chronic intraocular inflammation.\n8. History of retinal detachment.\n9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.\n10. Previous intraocular surgery.\n11. Previous corneal refractive surgery (i.e. laser-assisted in situ keratomileusis, photorefractive keratectomy, radial keratotomy).\n12. Previous keratoplasty\n13. Severe dry eye\n14. Pupil abnormalities\n15. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).\n16. Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.\n17. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.\n\nThe principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates the patient is unsuitable for the trial.'}, 'identificationModule': {'nctId': 'NCT05464732', 'briefTitle': 'Vivity IOL: Emmetropia Compared to Monovision.', 'organization': {'class': 'OTHER', 'fullName': 'Carolina Eyecare Physicians, LLC'}, 'officialTitle': 'Visual Outcomes, Patient Satisfaction and Spectacle Independence Evaluation of the Acrysof® IQ Vivity® Intraocular Lens Targeted for Emmetropia or Nanovision.', 'orgStudyIdInfo': {'id': 'CEP 20-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Monovision then emmetropia', 'description': 'The target refraction is plano (0.00 D) for the dominant eye and between -0.50 D and -0.75 D for the non-dominant eye. The Vivity IOL will be implanted bilaterally.\n\nCorrected vision will involve correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.', 'interventionNames': ['Device: Vivity IOL emmetropia', 'Device: Vivity IOL monovision']}, {'type': 'EXPERIMENTAL', 'label': 'Emmetropia then monovision', 'description': "Subject's vision will be tested with both eyes corrected for emmetropia. Subjects will then be tested correcting the dominant eye for emmetropia and the non-dominant eye for -0.50 D.", 'interventionNames': ['Device: Vivity IOL emmetropia', 'Device: Vivity IOL monovision']}], 'interventions': [{'name': 'Vivity IOL emmetropia', 'type': 'DEVICE', 'description': 'The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to bilateral emmetropia.', 'armGroupLabels': ['Emmetropia then monovision', 'Monovision then emmetropia']}, {'name': 'Vivity IOL monovision', 'type': 'DEVICE', 'description': 'The Vivity IOL will be implanted bilaterally in all subjects, tested with correction to emmetropia in the dominant eye and -0.50 in the non-dominant eye.', 'armGroupLabels': ['Emmetropia then monovision', 'Monovision then emmetropia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Eyecare Physicians, LLC', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}], 'overallOfficials': [{'name': 'Kerry Solomon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carolina Eyecare Physicians, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carolina Eyecare Physicians, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Science in Vision', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}