Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT06196593
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2023-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-24', 'size': 119293, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-24T00:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-24', 'studyFirstSubmitDate': '2023-12-24', 'studyFirstSubmitQcDate': '2023-12-24', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binocular UDVA', 'timeFrame': '3 months', 'description': 'Binocular Uncorrected Distance Visual Acuity'}, {'measure': 'Binocular UIVA', 'timeFrame': '3 months', 'description': 'Binocular Uncorrected Intermediate Visual Acuity'}, {'measure': 'Binocular UNVA', 'timeFrame': '3 months', 'description': 'Binocular Uncorrected Near Visual Acuity'}], 'secondaryOutcomes': [{'measure': 'CDVA', 'timeFrame': '3 months', 'description': 'Corrected Distance Visual Acuity'}, {'measure': 'DCIVA', 'timeFrame': '3 months', 'description': 'Distance Corrected Intermediate Visual Acuity'}, {'measure': 'DCNVA', 'timeFrame': '3 months', 'description': 'Distance Corrected Near Visual Acuity'}, {'measure': 'MRSE', 'timeFrame': '3 months', 'description': 'Mean Refractive Spherical Equivalent'}, {'measure': 'Rotational Stability', 'timeFrame': '1 month', 'description': 'Degree of rotation of intraocular lens'}, {'measure': 'Binocular Defocus Curve', 'timeFrame': '3 months', 'description': 'Measurement of the performance of the Intraocular lens at different distances'}, {'measure': 'Contrast Sensitivity', 'timeFrame': '3 months', 'description': 'Measurement of the contrast sensitivity after implantation with this intraocular lens'}, {'measure': 'QUVID', 'timeFrame': '3 months', 'description': 'Questionnaire on Visual Disturbances'}, {'measure': 'VF-14', 'timeFrame': '3 months', 'description': 'Visual function 14 index of questions designed to assess difficulty performing daily visual tasks'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cataract surgery', 'intraocular lens', 'non-diffractive extended depth of focus'], 'conditions': ['Cataract Senile', 'Intraocular Lens Complication']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to evaluate the clinical and patient reported outcomes after bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens.', 'detailedDescription': 'This is a prospective interventional case series of 30 patients who underwent cataract surgery and bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens. This study is represented by an Asian cohort of patients and the study evaluations were focused not only on clinical visual outcomes but also on "real-life" patient reported outcomes such as dysphotopsias, spectacle independence and daily visual tasks all of which were measured at 1 month and up to 3 months postoperatively. The objective would be to provide insight into the performance of this intraocular lens in Asian patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18 years or older\n* bilateral significant cataracts\n* bilateral significant corneal astigmatism\n\nExclusion Criteria:\n\n* previous refractive surgery\n* amblyopia\n* strabismus\n* any ocular co-morbidity which could impact on final visual acuity\n* pre-existing zonular weakness\n* capsular instability or compromise'}, 'identificationModule': {'nctId': 'NCT06196593', 'briefTitle': 'Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens', 'organization': {'class': 'OTHER', 'fullName': 'LEC Eye Centre'}, 'officialTitle': 'Visual Outcomes Following Bilateral Implantation of a Non-diffractive Wavefront-shaping Extended Depth of Focus Toric Intraocular Lens', 'orgStudyIdInfo': {'id': 'VTLEC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All eyes', 'description': 'All eyes implanted with AcrySof™ IQ Vivity™ Toric intraocular lens', 'interventionNames': ['Device: AcrySof™ IQ Vivity™ Toric intraocular lens']}], 'interventions': [{'name': 'AcrySof™ IQ Vivity™ Toric intraocular lens', 'type': 'DEVICE', 'description': 'Uneventful phacoemulsification and implantation of IOL', 'armGroupLabels': ['All eyes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30450', 'city': 'Ipoh', 'state': 'Perak', 'country': 'Malaysia', 'facility': 'LEC Eye Centre', 'geoPoint': {'lat': 4.5841, 'lon': 101.0829}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LEC Eye Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director', 'investigatorFullName': 'Mun Wai Lee', 'investigatorAffiliation': 'LEC Eye Centre'}}}}