Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-02 @ 10:36 AM
Study NCT ID:
NCT07140692
Status:
COMPLETED
Last Update Posted:
2025-08-25
First Post:
2025-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C000726608', 'term': 'vitreous floaters'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The Vista Ophthalmics 1-Step Vitrector is intended to perform anterior/posterior vitrectomy procedures and remove vitreous and dissected tissue in the eye. It consists of a single-use vitrector with air supply tubing.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of change in iTrace Dysfunctional Lens Index (DLI) from baseline to post-operative visit Day 30', 'timeFrame': 'Day 30 (+/- 7 days)', 'description': 'iTrace Dysfunctional Lens Index (DLI) score'}, {'measure': 'Degree of change in Kim Floater Survey from baseline to post-operative visit Day 30', 'timeFrame': 'Day 30 (+/-7 days)', 'description': 'Assessment using Kim Floater Questionnaire'}, {'measure': 'Degree of change in surgeon assessed vitreous opacities from baseline to post-operative visit Day 30', 'timeFrame': 'Day 30 (+/-7 days)', 'description': 'Dilated Fundus/Peripheral Exam'}], 'secondaryOutcomes': [{'measure': 'Incidence of post-operative adverse events', 'timeFrame': 'Day 30 (+/- 7 days)', 'description': 'Ophthalmic examination'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Vitrectomy', 'Vista 1-Step Vitrector', 'Vitreous opacities or floaters'], 'conditions': ['Vitreous Floaters', 'Vitreous Opacities']}, 'descriptionModule': {'briefSummary': 'Vitreous opacities or floaters are a common ocular condition that can cause significant impairment in vision-related quality of life (QoL) in some patients. Vitrectomy involves the surgical removal of vitreous humour, the transparent jelly, from inside the eye that contains vitreous opacities and floaters. The present post-market clinical assessment study aims to assess the safety and effectiveness performance of the Vista 1-Step vitrectomy probe in adult pseudophakic patients with visually symptomatic opacities.', 'detailedDescription': 'Vitreous opacities or floaters are a common ocular condition that seems ubiquitous in a retina practice. Although symptoms are minimal in most patients, they can cause significant impairment in vision-related quality of life (QoL) in some patients.\n\nVitrectomy is a surgical procedure to remove the vitreous humour, the transparent jelly, from inside the eye. Vitrectomy Surgery can be of two types: Full and Limited. Full Vitrectomy is the commonly used and standard technique for repairing retinal detachments, removing membranes or haemorrhages, and involves vitreous detachment from the retina and its removal, both centrally and peripherally. Limited Vitrectomy is a new technique which focuses on the removal of only the central part of the vitreous or Core with the Vitreous Opacities or "Floaters" in it, and without intentionally detaching it from the retina.\n\nThe Vista Ophthalmics vitrectomy probe is a single-use vitrector intended to perform anterior/posterior vitrectomy procedures and to remove vitreous and dissect tissue in the eye. The Vista Ophthalmic\'s probe is designed as a stand-alone handpiece for use with ophthalmic systems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female participant with age ≥ 18 years at the time of screening.\n2. Subjects with Posterior chamber Intraocular lens (PCIOL) in one or both the eyes (both eyes will be independently assessed).\n3. 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.\n4. Subjects must be willing and able to comply with all treatment and follow-up study procedures.\n5. Complaints of decreased vision/decreased quality of vision due to vitreous floaters which is having an impact on Activities of daily living (ADLs).\n6. Documentation of vitreous opacities on Slit lamp exam/Dilated Fundus Exam (SLE/DFE).\n7. Documentation of decreased DLI on iTrace.\n\nExclusion Criteria:\n\n1. Subjects with history of retinal tear/detachment, macular edema, Epi-retinal membrane (ERM), vitreomacular traction syndrome (VMT), Age-related macular degeneration (AMD), Proliferative Diabetic Retinopathy (PDR), or other significant retinal disorders in procedural eye.\n2. Subjects with History of trauma to operative eye.\n3. Subjects with bleeding disorders or anticoagulation.\n4. Subjects with history of ocular herpetic infections.\n5. Female subjects of child bearing potential with positive urine pregnancy test.\n6. Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into or during this study.\n7. Any medical condition that would be contraindicated for cataract surgery.'}, 'identificationModule': {'nctId': 'NCT07140692', 'briefTitle': 'EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE', 'organization': {'class': 'OTHER', 'fullName': 'The Eye Centers of Racine and Kenosha'}, 'officialTitle': 'VISTA OPHTHALMICS 1-STEP VITRECTOR POST MARKET LIMITED VITREOUS REMOVAL (LVR) CLINICAL ASSESSMENT', 'orgStudyIdInfo': {'id': 'ECRK-LVR-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vista Ophthalmics vitrectomy', 'description': 'In this single-arm, non-comparative study, patients presenting with vitreous opacities affecting daily activities of living will undergo vitrectomy using the single-use vitrector probe of Vista Ophthalmics for the removal of the vitreous opacities.', 'interventionNames': ['Device: Vitrectomy']}], 'interventions': [{'name': 'Vitrectomy', 'type': 'DEVICE', 'description': 'In this single-arm, non-comparative study, patients presenting with vitreous opacities affecting daily activities of living will undergo vitrectomy using the single-use vitrector probe of Vista Ophthalmics for the removal of the vitreous opacities.', 'armGroupLabels': ['Vista Ophthalmics vitrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53142', 'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Eye Centers of Racine & Kenosha', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Eye Centers of Racine and Kenosha', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmologist and President, The Eye Centers of Racine & Kenosha', 'investigatorFullName': 'Inder Paul Singh, M.D.', 'investigatorAffiliation': 'The Eye Centers of Racine and Kenosha'}}}}