Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-09 @ 2:18 AM
Study NCT ID:
NCT03267134
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2017-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydrus Microstent for Refractory Open-Angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-15', 'mcpReleaseN': 9, 'releaseDate': '2025-12-01'}, {'releaseDate': '2025-12-21'}], 'estimatedResultsFirstSubmitDate': '2025-12-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'dispFirstSubmitDate': '2023-12-11', 'completionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2017-08-28', 'dispFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline', 'timeFrame': 'Baseline, Month 12', 'description': 'IOP will be measured using Goldmann Applanation tonometry. Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve MDIOP.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in MDIOP at Month 12', 'timeFrame': 'Baseline, Month 12', 'description': 'IOP will be measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve MDIOP.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Glaucoma'], 'conditions': ['Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.', 'detailedDescription': 'Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Open-angle glaucoma with optic nerve pathology;\n* Best Corrected Visual Acuity of 20/80 or better in study eye;\n* Refractory glaucoma;\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma;\n* Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma;\n* Pre-perimetric glaucoma;\n* Ocular hypertension\n* Shallow or flat anterior chamber;\n* Other protocol-specified exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03267134', 'acronym': 'SUMMIT', 'briefTitle': 'Hydrus Microstent for Refractory Open-Angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ivantis, Inc.'}, 'officialTitle': 'The Hydrus Microstent for Refractory Open-Angle Glaucoma: A Prospective, Multicenter Clinical Trial (Hydrus VII Study)', 'orgStudyIdInfo': {'id': 'CP 16-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydrus Microstent', 'description': 'Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted.', 'interventionNames': ['Device: Hydrus Microstent', 'Procedure: Ophthalmic surgery']}], 'interventions': [{'name': 'Hydrus Microstent', 'type': 'DEVICE', 'description': "Device implanted into the Schlemm's canal of the eye for the purpose of providing a natural outflow pathway for aqueous humor. The Hydrus Microstent is intended for lifetime use of the glaucoma patient.", 'armGroupLabels': ['Hydrus Microstent']}, {'name': 'Ophthalmic surgery', 'type': 'PROCEDURE', 'description': 'Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia', 'armGroupLabels': ['Hydrus Microstent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento Eye Consultants', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eye Center of Northern Colorado', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Eye', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34283', 'city': 'Venice', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Sight', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}, {'zip': '66213', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Stiles Eyecare', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '71303', 'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Eye and Laser Center', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis Ophthalmology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '16066', 'city': 'Cranberry Township', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scott & Christie and Associates', 'geoPoint': {'lat': 40.68496, 'lon': -80.10714}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texan Eye', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Glaucoma Associates of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Eye Surgeons', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '76102', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Vale-Asche Russell Clinical Research Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'R and R Research, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53142', 'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Eye Centers of Racine and Kenosha', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}, {'zip': '080020', 'city': 'Barranquilla', 'country': 'Colombia', 'facility': 'Clínica Oftalmológica', 'geoPoint': {'lat': 10.96854, 'lon': -74.78132}}, {'zip': '1200', 'city': 'Makati City', 'country': 'Philippines', 'facility': 'Asian Eye Institute', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Eye Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Clinical Project Lead, CRD Surgical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivantis, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}