Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT05689333
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2022-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Performance of the Vista Probe for Vitrectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2023-01-16', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of post-operative rates of retinal tears', 'timeFrame': 'Month 1', 'description': 'Calculate the incidence of post-operative rates of retinal tears'}, {'measure': 'Incidence of retinal detachment', 'timeFrame': 'Month 1', 'description': 'Calculate the incidence of post-operative retinal detachment'}, {'measure': 'Incidence of sclerotomy complications like leakage', 'timeFrame': 'Month 1', 'description': 'Calculate the incidence of post-operative sclerotomy complications like leakage'}, {'measure': 'Incidence of ocular hypotony', 'timeFrame': 'Month 1', 'description': 'Calculate the incidence of post-operative ocular hypotony'}, {'measure': 'Incidence of choroidal detachment', 'timeFrame': 'Month 1', 'description': 'Calculate the incidence of post-operative choroidal detachment'}, {'measure': 'Incidence of visually significant vitreous hemorrhage', 'timeFrame': 'Month 1', 'description': 'Calculate the incidence of post-operative visually significant vitreous hemorrhage (visual acuity defined by counting fingers or worse)'}, {'measure': 'Incidence of endophthalmitis', 'timeFrame': 'Month 1', 'description': 'Calculate the incidence of post-operative endophthalmitis'}], 'secondaryOutcomes': [{'measure': 'Surgeon- will assess device adequacy for removal of vitreous', 'timeFrame': 'Day 0 (Operative Visit)', 'description': 'Surgeon-assess device adequacy for removal of vitreous will be summarized using counts and percentages'}, {'measure': 'Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking', 'timeFrame': 'Days1, 7, 30 & 90', 'description': 'Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking, at any post-operative visit will be summarized using counts and percentages'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Vitrectomy Probe', 'Vitreous aspiration & cutting', 'Dissect tissue in the eye'], 'conditions': ['Vitrectomy']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participant with age ≥ 18 years at the time of screening.\n* Subject must have a clinical indication for anterior vitrectomy.\n* Subjects must be able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.\n* Subjects must be willing and able to comply with all treatment and follow-up study procedures.\n\nExclusion Criteria:\n\n* Subjects who have experienced any significant trauma in the operative eye within the past month.\n* Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.\n* Subjects with prior history of uncontrolled glaucoma or uveitis refractory to treatment or ocular hypertension (IOP\\>30mm Hg) in study eye.\n* Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigator's medical judgment, poses a concern for the subjects' safety.\n* Female subjects of child bearing potential with positive urine pregnancy test\n* Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into or during this study."}, 'identificationModule': {'nctId': 'NCT05689333', 'briefTitle': 'A Study to Evaluate the Safety and Performance of the Vista Probe for Vitrectomy Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'VISTA Ophthalmics'}, 'officialTitle': 'A Prospective, Single-arm, Non-comparative, Open-label, Monocular, Post Approval Study to Assess Safety and Device Performance of the Vista Vitrectomy Probe During Vitrectomy Surgery', 'orgStudyIdInfo': {'id': 'CBCC/2022/009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '27 GA Vista Ophthalmics vitrector', 'description': 'The vitrectomy will be performed through the pars plana using the 27 GA Vista Ophthalmics vitrector.', 'interventionNames': ['Device: Vista Vitrectomy Probe']}], 'interventions': [{'name': 'Vista Vitrectomy Probe', 'type': 'DEVICE', 'description': 'Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector', 'armGroupLabels': ['27 GA Vista Ophthalmics vitrector']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90067', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'CBCC Global Research Site:003', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'CBCC Global Research Site:002', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '19004', 'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CBCC Global Research Site:001', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'CBCC Global Research Site:004', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}], 'overallOfficials': [{'name': 'Don Knowles', 'role': 'STUDY_CHAIR', 'affiliation': 'VISTA Ophthalmics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VISTA Ophthalmics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CBCC Global Research', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}