Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT01444105
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2011-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2011-09-28', 'studyFirstSubmitQcDate': '2011-09-28', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean diurnal IOP (mm Hg) at the Month 12 visit.', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open angle glaucoma', 'Pseudoexfoliative glaucoma'], 'conditions': ['Open-angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '35943114', 'type': 'DERIVED', 'citation': 'Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.', 'detailedDescription': 'Evaluation of intraocular pressure (IOP) lowering effect of two iStent stents versus a SLT procedure in subjects with open-angle glaucoma on one ocular hypotensive medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Phakic study eye or study eye with a posterior chamber intraocular lens (PC-IOL)\n* Primary open-angle glaucoma (including pseudoexfoliative)\n\nExclusion Criteria:\n\n* Aphakic or pseudophakic with anterior chamber IOLs (AC-IOLs) (study eye)\n* Prior stent implantations (study eye)'}, 'identificationModule': {'nctId': 'NCT01444105', 'briefTitle': 'Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Parallel Groups Evaluation of Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty', 'orgStudyIdInfo': {'id': 'GCF-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iStent', 'description': 'implantation of two iStent devices', 'interventionNames': ['Device: iStent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLT', 'description': 'Laser treatment', 'interventionNames': ['Other: SLT']}], 'interventions': [{'name': 'iStent', 'type': 'DEVICE', 'description': 'Implantation of two iStent devices', 'armGroupLabels': ['iStent']}, {'name': 'SLT', 'type': 'OTHER', 'description': 'Laser treatment', 'armGroupLabels': ['SLT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0001', 'city': 'Yerevan', 'country': 'Armenia', 'facility': 'S.V. Malayan Ophthalmological Center', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}], 'overallOfficials': [{'name': 'Lilit A Voskanyan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'S.V. Malayan Ophthalmological Center, Yerevan, Armenia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glaukos Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}