Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 2:30 PM
Study NCT ID:
NCT06229106
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2024-01-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Symfony vs Vivity in Dim Light
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': 'hsandoval@cepmd.com', 'phone': '8438813937', 'title': 'Director of Clinical Research', 'organization': 'Carolina Eyecare Physicians, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Symfony Optiblue IOL', 'description': 'The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nSymfony IOL: The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clareon Vivity IOL', 'description': 'The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nVivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symfony Optiblue IOL', 'description': 'The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nSymfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}, {'id': 'OG001', 'title': 'Clareon Vivity IOL', 'description': 'The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nVivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after surgery', 'description': 'logMAR visual acuity', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symfony Optiblue IOL', 'description': 'The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nSymfony IOL: The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}, {'id': 'OG001', 'title': 'Clareon Vivity IOL', 'description': 'The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nVivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after surgery', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symfony Optiblue IOL', 'description': 'The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nSymfony IOL: The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}, {'id': 'OG001', 'title': 'Clareon Vivity IOL', 'description': 'The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nVivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.44', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after surgery', 'description': 'Visual acuity measured at 4 m', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symfony Optiblue IOL', 'description': 'The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nSymfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}, {'id': 'FG001', 'title': 'Clareon Vivity IOL', 'description': 'The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nVivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Symfony Optiblue IOL', 'description': 'The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nSymfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}, {'id': 'BG001', 'title': 'Clareon Vivity IOL', 'description': 'The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.\n\nVivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.18', 'spread': '7.02', 'groupId': 'BG000'}, {'value': '70.16', 'spread': '5.62', 'groupId': 'BG001'}, {'value': '70.17', 'spread': '6.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-22', 'size': 216211, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-23T18:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2024-01-19', 'resultsFirstSubmitDate': '2025-01-24', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-24', 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions.', 'timeFrame': '3 months after surgery', 'description': 'logMAR visual acuity'}], 'secondaryOutcomes': [{'measure': 'Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions.', 'timeFrame': '3 months after surgery'}, {'measure': 'Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions', 'timeFrame': '3 months after surgery', 'description': 'Visual acuity measured at 4 m'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with a target refraction of plano OU.\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 in both eyes, with 1 to 30 days between surgeries.\n7. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.\n\nExclusion Criteria:\n\n1. Severe preoperative ocular pathology\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. Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities.\n8. History of chronic intraocular inflammation.\n9. History of retinal detachment.\n10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.\n11. Previous intraocular surgery.\n12. Previous corneal refractive surgery (i.e., LASIK, PRK, RK).\n13. Subject who declined any type of presbyopia correcting IOL due to concerns with visual disturbances (i.e., halos)\n14. Previous keratoplasty\n15. Severe dry eye\n16. Pupil abnormalities\n17. Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK)\n18. 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.\n19. 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.'}, 'identificationModule': {'nctId': 'NCT06229106', 'briefTitle': 'Symfony vs Vivity in Dim Light', 'organization': {'class': 'OTHER', 'fullName': 'Carolina Eyecare Physicians, LLC'}, 'officialTitle': 'Evaluation of the Symfony With Optiblue Intraocular Lens Compared to The Vivity IOL Under Mesopic Conditions', 'orgStudyIdInfo': {'id': 'CEP 23-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Symfony IOL', 'description': 'The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.', 'interventionNames': ['Device: Symfony IOL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vivity IOL', 'description': 'The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.', 'interventionNames': ['Device: Vivity IOL']}], 'interventions': [{'name': 'Symfony IOL', 'type': 'DEVICE', 'description': 'The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.', 'armGroupLabels': ['Symfony IOL']}, {'name': 'Vivity IOL', 'type': 'DEVICE', 'description': 'The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism.', 'armGroupLabels': ['Vivity IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Sight', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Eyecare Physicians, LLC', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carolina Eyecare Physicians, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Science in Vision', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}