Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT01052558
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2010-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 164}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-18', 'studyFirstSubmitDate': '2010-01-13', 'studyFirstSubmitQcDate': '2010-01-19', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with 12 month diurnalIOP </= 21 mmHg without use of ocular hypotensive medications for >/= 4 weeks prior to 12 month visit.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Open angle', 'Glaucoma', 'Cataract', 'Surgery', 'Intraocular Pressure'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle glaucoma or ocular hypertension and co-existing cataract.', 'detailedDescription': 'Glaucoma is a collection of disorders characterized by progressive loss of visual field due to optic nerve damage. It is a leading cause of blindness in the United States, affecting 1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long treatment with a spectrum of therapeutic options including medications, laser treatment and surgical implants. The common goal among the various therapies is to lower intraocular pressure to target levels in order to prevent loss of visual fields from excessive pressure on the optic nerve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with open-angle glaucoma in the study eye\n* Subject must be on 1 to 3 glaucoma medications\n* Subject able and willing to attend follow up visits for two years postop\n* Subject able and willing to sign informed consent\n\nExclusion Criteria:\n\n* Pseudoexfoliative and pigmentary glaucoma\n* Prior glaucoma surgery of any type'}, 'identificationModule': {'nctId': 'NCT01052558', 'briefTitle': 'GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Parallel Groupos, Multicenter Clinical Investigation of the Glaukos Trabecular Micro-bypass Stent Model GTS400 in Conjunction With Cataract Surgery', 'orgStudyIdInfo': {'id': 'GC-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cataract Surgery Only', 'interventionNames': ['Procedure: Cataract Surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment with Cataract Surgery & Stents', 'description': 'Ab interno trabecular micro-bypass stent surgery', 'interventionNames': ['Device: iStent Inject (GTS400)']}], 'interventions': [{'name': 'iStent Inject (GTS400)', 'type': 'DEVICE', 'otherNames': ['Cataract surgery, stent implantation'], 'description': 'Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.', 'armGroupLabels': ['Treatment with Cataract Surgery & Stents']}, {'name': 'Cataract Surgery', 'type': 'PROCEDURE', 'description': 'Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.', 'armGroupLabels': ['Cataract Surgery Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72756', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Boozman-Hof Regional Eye Clinic', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'North Bay Eye Associates, Inc.', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '80134', 'city': 'Parker', 'state': 'Colorado', 'country': 'United States', 'facility': 'Glaucoma Consultants of Colorado', 'geoPoint': {'lat': 39.5186, 'lon': -104.76136}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'The Center for Excellence in Eye Care', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'International Eye Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30260', 'city': 'Morrow', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clayton Eye Center / Eye Care Centers Management, Inc.', 'geoPoint': {'lat': 33.58317, 'lon': -84.33937}}, {'zip': '60619', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Eye Specialists', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46240', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Whitson Vision, PC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '01523', 'city': 'Lancaster', 'state': 'Massachusetts', 'country': 'United States', 'facility': "D'Ambrosio Eye Care", 'geoPoint': {'lat': 42.45565, 'lon': -71.67312}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kresge Eye Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64055', 'city': 'Independence', 'state': 'Missouri', 'country': 'United States', 'facility': 'Discover Vision Centers', 'geoPoint': {'lat': 39.09112, 'lon': -94.41551}}, {'zip': '64133', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Silverstein Eye Centers', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Medical Research Institute", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '75965', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'Las Vegas Physician Research Group', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Shepherd Eye Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Long Island', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Thomas Mundorf, MD', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '15825', 'city': 'Brookville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Laurel Eye Clinic', 'geoPoint': {'lat': 41.16117, 'lon': -79.08309}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Eyecare Physicians', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision / Sanford Clinic', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texan Eye', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75965', 'city': 'Nacogdoches', 'state': 'Texas', 'country': 'United States', 'facility': 'Lehmann Eye Center', 'geoPoint': {'lat': 31.60351, 'lon': -94.65549}}], 'overallOfficials': [{'name': 'Jeff Wells, PharmD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glaukos Corporation'}, {'name': 'Jay Katz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wills Eye Institute; Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}