Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT05488769
Status:
TERMINATED
Last Update Posted:
2023-01-19
First Post:
2022-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007910', 'term': 'Lenses, Intraocular'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Investigational product not available', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-16', 'studyFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction questionnaire', 'timeFrame': '3 months postoperative', 'description': 'The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.'}, {'measure': 'Visual disturbances questionnaire', 'timeFrame': '3 months postoperative', 'description': 'Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.'}, {'measure': 'Binocular uncorrected and distance-corrected visual acuity at near (40cm)', 'timeFrame': '3 months postoperative'}], 'primaryOutcomes': [{'measure': 'Binocular distance-corrected visual acuity at distance (6m)', 'timeFrame': '3 months postoperative'}, {'measure': 'Binocular distance-corrected visual acuity at intermediate (66cm)', 'timeFrame': '3 months postoperative'}], 'secondaryOutcomes': [{'measure': 'Percentage of eyes with absolute prediction error less than or equal to 0.50D', 'timeFrame': '3 months postoperative'}, {'measure': 'Percentage of eyes with refractive astigmatism less than or equal to 0.50 D', 'timeFrame': '3 months postoperative'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.', 'detailedDescription': 'This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible test subjects will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for intermediate and distance vision, and who are considered appropriate candidates for EDOF 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\n* Visually significant age-related cataracts bilaterally.\n* Best monocular Corrected distance Visual Acuity predicted to be (20/25) or better after cataract removal and IOL implantation as determined by surgeon.\n* Gender: Males and Females.\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* Clear intraocular media other than cataract.\n* Planned Bilateral implantation of the Clareon Vivity and Vivity toric IOLs.\n* IOL powers between 6D and 30D, T2-T6.\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* Previous ocular or refractive surgery\n* Ocular surface disease/Dry Eye Disease\n* Intraoperative complications during procedure\n* Glaucoma, including well-controlled\n* Any disorders that reduce binocular vision (ie Strabismus)\n* Any ocular comorbidity that, in the opinion of the investigator reduce post-op visual acuity (e.g. AMD etc)\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': 'NCT05488769', 'briefTitle': 'Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material', 'organization': {'class': 'OTHER', 'fullName': 'Vision North Eye Centre'}, 'officialTitle': 'Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material', 'orgStudyIdInfo': {'id': 'TN-22-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Clareon Vivity extended depth of focus (EDOF) intraocular lens', 'description': 'Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens', 'interventionNames': ['Device: Clareon Vivity extended depth of focus (EDOF) intraocular lens']}], 'interventions': [{'name': 'Clareon Vivity extended depth of focus (EDOF) intraocular lens', 'type': 'DEVICE', 'description': 'Implantation with the Clareon Vivity extended depth of focus (EDOF) intraocular lens', 'armGroupLabels': ['Clareon Vivity extended depth of focus (EDOF) intraocular lens']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V8G 1V7', 'city': 'Terrace', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vision North Eye Centre', 'geoPoint': {'lat': 54.51634, 'lon': -128.60345}}], 'overallOfficials': [{'name': 'Thomas Nagy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vision North Eye Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Nagy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sengi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Thomas Nagy', 'investigatorAffiliation': 'Vision North Eye Centre'}}}}