Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-27 @ 5:45 AM
Study NCT ID:
NCT07070492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Combined Cataract Surgery With Retinal Surgery for Visually Significant Epiretinal Membrane With Vivity Versus Monofocal Intraocular Lens
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': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2025-06-24', 'studyFirstSubmitQcDate': '2025-07-07', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vision Acuity', 'timeFrame': 'At the study visit at least 3 months after the combined cataract and retinal surgeries'}], 'secondaryOutcomes': [{'measure': 'Contrast Sensitivity', 'timeFrame': 'At the study visit at least 3 months after the combined cataract and retinal surgeries'}, {'measure': 'Patient Reported Outcomes (PRO) on vision-related Quality of Life (QOL) and satisfaction', 'timeFrame': 'At the study visit at least 3 months after the combined cataract and retinal surgeries', 'description': "Using 5-point Likert scale, Research Insight's Validated PRO Questionnaire to assess patient overall satisfaction post-surgery, QOL on driving, reading, computer use, watching TV, sports, and Glare/Haloes."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract and IOL Surgery', 'Epi-retinal Membrane']}, 'descriptionModule': {'briefSummary': 'To investigate the patient Quality of Life and satisfaction outcomes of combined cataract surgery with retinal surgery for visually significant epiretinal membrane in patients receiving Vivity IOL versus standard monofocal controls.', 'detailedDescription': 'The information gained by this study will help understand better the suitability of Vivity IOLs for patients with a common retinal condition and potentially expand access and offering of premium IOLs to help patients gain independence from glasses, which can improve quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with visually significant epiretinal membrane who are undergoing or have already had pars plana vitrectomy and membrane peel combined with cataract surgery using Clareon Vivity and Clareon Vivity Toric IOLs or monofocal IOL\n* IOL powers between +6D to +30.0D, T3-T6\n\nExclusion Criteria:\n\n* History of ocular or refractive surgery\n* Other ocular or systemic comorbidities that may alter or reduce visual acuity and contrast sensitivity, such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, strabismus/amblyopia etc.\n* Patients with irregular astigmatism, corneal dystrophies, pupil abnormalities, zonular laxity\n* Intraoperative or postoperative complications'}, 'identificationModule': {'nctId': 'NCT07070492', 'briefTitle': 'Outcomes of Combined Cataract Surgery With Retinal Surgery for Visually Significant Epiretinal Membrane With Vivity Versus Monofocal Intraocular Lens', 'organization': {'class': 'OTHER', 'fullName': 'Sutter Health'}, 'officialTitle': 'Outcomes of Combined Cataract Surgery With Retinal Surgery for Visually Significant Epiretinal Membrane With Vivity Versus Monofocal Intraocular Lens', 'orgStudyIdInfo': {'id': '2025.067-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vivity Extended Depth of Focus IOL', 'interventionNames': ['Device: cataract surgery', 'Procedure: retinal surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard monofocal IOL', 'interventionNames': ['Device: cataract surgery', 'Procedure: retinal surgery']}], 'interventions': [{'name': 'cataract surgery', 'type': 'DEVICE', 'description': 'cataract surgery receiving Vivity IOL or standard mono focal controls', 'armGroupLabels': ['Standard monofocal IOL', 'Vivity Extended Depth of Focus IOL']}, {'name': 'retinal surgery', 'type': 'PROCEDURE', 'description': 'Retinal surgery for visually significant epiretinal membrane', 'armGroupLabels': ['Standard monofocal IOL', 'Vivity Extended Depth of Focus IOL']}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'CSR'], 'timeFrame': 'After the final results were published and released to the public.', 'ipdSharing': 'YES', 'description': 'Patient Report Outcomes on Quality of Life and satisfaction', 'accessCriteria': 'Researchers will have to make explicit request to the corresponding author to determine if any individual participant data can be released. No Personal Health Information and personal identifiers will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debbie Kuo, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Palo Alto Foundation Medical Group affiliated Ophthalmologist', 'investigatorFullName': 'Debbie Kuo, MD', 'investigatorAffiliation': 'Sutter Health'}}}}