Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 7:28 AM
Study NCT ID:
NCT05280366
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-12
First Post:
2021-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-03-14', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean unmedicated diurnal Intraocular Pressure (IOP)', 'timeFrame': '24 months', 'description': 'Change in mean unmedicated diurnal Intraocular Pressure (IOP) over time'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['glaucoma', 'Goniotomy', 'MIGS'], 'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'A study of the Streamline Surgical System versus competitor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of Mild to Moderate Primary Open Angle Glaucomma\n\nExclusion Criteria:\n\n* Other types of glaucoma including but not limited to: Normal tension glaucoma, pseudoexfoliative glaucoma, narrow angle glaucoma, traumatic, congenital, malignant, uveitic or neovascular glaucoma. Ocular hypertension.'}, 'identificationModule': {'nctId': 'NCT05280366', 'acronym': 'VENICE', 'briefTitle': 'STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'New World Medical, Inc.'}, 'officialTitle': 'A Prospective, Randomized, Multi-center Evaluation of the Safety and Effectiveness of the STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma', 'orgStudyIdInfo': {'id': 'DF6-CL-21-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Streamline Surgical System', 'description': 'Streamline Surgical System procedure administered', 'interventionNames': ['Device: Streamline Surgical System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'iStent Inject W', 'description': 'iStent Inject W implanted', 'interventionNames': ['Device: iStent Inject W']}], 'interventions': [{'name': 'Streamline Surgical System', 'type': 'DEVICE', 'description': 'Completion of the Streamline Surgical System procedure', 'armGroupLabels': ['Streamline Surgical System']}, {'name': 'iStent Inject W', 'type': 'DEVICE', 'description': 'Implantation of competitor device', 'armGroupLabels': ['iStent Inject W']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Visionary Research Institute', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Wolstan and Goldberg Eye Associates', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Eye', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Eye Partners', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Eye Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07927', 'city': 'Dover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Eye Associates of North New Jersey', 'geoPoint': {'lat': 40.88399, 'lon': -74.5621}}, {'zip': '08361', 'city': 'Vineland', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Eye Associates Surgical Center', 'geoPoint': {'lat': 39.48623, 'lon': -75.02573}}, {'zip': '14127', 'city': 'Orchard Park', 'state': 'New York', 'country': 'United States', 'facility': 'Ross Eye Institute', 'geoPoint': {'lat': 42.76756, 'lon': -78.74392}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Black Hills Regional Eye Institute', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37003', 'city': 'Maryville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University Eye Specialists', 'geoPoint': {'lat': 35.75647, 'lon': -83.97046}}, {'zip': '76102', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Berkely Eye Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'R & R Eye Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '24052', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Piedmont Eye Center', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '53405', 'city': 'Racine', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Eye Centers of Racine and Kenosha', 'geoPoint': {'lat': 42.72613, 'lon': -87.78285}}, {'zip': '10108', 'city': 'San José', 'country': 'Costa Rica', 'facility': 'Clinica 20/20', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'zip': '72530', 'city': 'Puebla City', 'country': 'Mexico', 'facility': 'Clinica Laser y Ultrasonido Ocular', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}], 'overallOfficials': [{'name': 'Elysia Ison, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'New World Medical, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New World Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}