Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-02 @ 4:55 AM
Study NCT ID:
NCT00326066
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2006-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'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': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-07', 'studyFirstSubmitDate': '2006-05-12', 'studyFirstSubmitQcDate': '2006-05-12', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Open angle', 'Glaucoma', 'Surgery', 'Cataract'], 'conditions': ['Open-Angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '20207977', 'type': 'DERIVED', 'citation': 'Fernandez-Barrientos Y, Garcia-Feijoo J, Martinez-de-la-Casa JM, Pablo LE, Fernandez-Perez C, Garcia Sanchez J. Fluorophotometric study of the effect of the glaukos trabecular microbypass stent on aqueous humor dynamics. Invest Ophthalmol Vis Sci. 2010 Jul;51(7):3327-32. doi: 10.1167/iovs.09-3972. Epub 2010 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in subjects with newly diagnosed open-angle glaucoma and subjects diagnosed with Ocular hypertension.', 'detailedDescription': 'The study will compare the reduction in IOP of those subjects implanted with two Glaukos micro-stents with the reduction in IOP for patients receiving only primary medical therapy (Xalatan - Latanoprost) or cataract surgery alone. Both groups will undergo routine cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects not yet taking any glaucoma medications or recently diagnosed with mild open-angle glaucoma and are currently being treated with up to 2 glaucoma medications.\n* All subjects must need cataract surgery.\n\nExclusion Criteria:\n\n* Angle closure glaucoma\n* Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic or angle recession glaucoma\n* Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt implant, collagen implant, cyclo destructive procedures etc)\n* Fellow eye already enrolled'}, 'identificationModule': {'nctId': 'NCT00326066', 'briefTitle': 'A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension', 'orgStudyIdInfo': {'id': 'GCF-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Device: Glaucoma Surgery']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Procedure: cataract surgery only']}], 'interventions': [{'name': 'Glaucoma Surgery', 'type': 'DEVICE', 'otherNames': ['two Glaukos iStent Trabecular Bypass Microstents'], 'description': 'Comparing the effect in reducing IOP with two Trabecular Bypass Microstents Versus none in patients undergoing cataract surgery, with early open angle glaucoma or ocular hypertension.', 'armGroupLabels': ['1']}, {'name': 'cataract surgery only', 'type': 'PROCEDURE', 'otherNames': ['Phacoemulsification'], 'description': 'Subjects will undergo routine cataract surgery only (no stent implant).', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Vienna Medical Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Mainz University', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81675', 'city': 'Munich', 'country': 'Germany', 'facility': 'Augenklinik der Technischen Universitat', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'D-97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitats- Augenklinik', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'The Netherlands Ophthalmic Research Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Ophthalmic Clinic', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '50007', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Instituto Oftalmológico de Aragón', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Beyoglu Eye Research and Education Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Head of Clinical Affairs', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Glaukos Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}