Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT01455467
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 Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2011-09-28', 'studyFirstSubmitQcDate': '2011-10-18', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Open angle glaucoma', 'Pigmentary glaucoma', 'Pseudoexfoliative glaucoma'], 'conditions': ['Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'Evaluation of intraocular pressure (IOP) lowering effect of one iStent versus two iStents in conjunction with cataract surgery in subjects with primary open-angle glaucoma, washed out of one anti-glaucoma medication prior to stent implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Phakic study eye requiring cataract removal and posterior chamber intraocular lens (PC-IOL) implantation\n* Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)\n\nExclusion Criteria:\n\n* Aphakic or pseudophakic with posterior or anterior chamber IOLs (PC-IOLs or AC-IOLs) (study eye)\n* Prior stent implantations (study eye)'}, 'identificationModule': {'nctId': 'NCT01455467', 'briefTitle': 'Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Glaukos Corporation'}, 'officialTitle': 'A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery', 'orgStudyIdInfo': {'id': 'GCF-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'One iStent', 'description': 'Implantation of one iStent in conjunction with cataract surgery', 'interventionNames': ['Device: One iStent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Two iStent', 'description': 'Implantation of two iStent devices in conjunction with cataract surgery', 'interventionNames': ['Device: Two iStent']}], 'interventions': [{'name': 'One iStent', 'type': 'DEVICE', 'description': 'Implantation of one iStent in conjunction with cataract surgery', 'armGroupLabels': ['One iStent']}, {'name': 'Two iStent', 'type': 'DEVICE', 'description': 'Implantation of two iStent in conjunction with cataract surgery', 'armGroupLabels': ['Two iStent']}]}, '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'}}}}