Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-28 @ 6:55 PM
Study NCT ID:
NCT00551902
Status:
WITHDRAWN
Last Update Posted:
2015-09-23
First Post:
2007-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Efficacy study indicated that further study is not warranted', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2007-10-29', 'studyFirstSubmitQcDate': '2007-10-29', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical success: intraocular pressure lowered by 30% and functional filtering bleb', 'timeFrame': '2 weeks, 1 month, 3 months, 6 months and 1 year post surgery'}], 'secondaryOutcomes': [{'measure': 'Need for laser suture lysis', 'timeFrame': 'any point post operatively'}, {'measure': 'complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing', 'timeFrame': 'any time post operatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'trabeculectomy', 'anterior chamber maintainer', 'anterior chamber infusion'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Titrating suture tightness is important to achieving the desired post-operative intraocular pressure. This process is not straightforward and intraocular pressures are often too high or too low post-operatively.', 'detailedDescription': 'The use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes.\n\nThus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* One of the following diagnoses:\n\n * primary open angle glaucoma\n * chronic angle closure glaucoma\n * pseudo exfoliation glaucoma\n * pigment dispersion glaucoma\n\nExclusion Criteria:\n\n* unable to provide consent or return for follow up'}, 'identificationModule': {'nctId': 'NCT00551902', 'briefTitle': 'Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes', 'orgStudyIdInfo': {'id': 'RC-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Trabeculectomy with anterior chamber infusion system', 'interventionNames': ['Procedure: Trabeculectomy with anterior chamber infusion system']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Trabeculectomy without anterior chamber infusion system', 'interventionNames': ['Procedure: Trabeculectomy without anterior chamber infusion system']}], 'interventions': [{'name': 'Trabeculectomy with anterior chamber infusion system', 'type': 'PROCEDURE', 'description': 'Trabeculectomy with anterior chamber infusion system', 'armGroupLabels': ['1']}, {'name': 'Trabeculectomy without anterior chamber infusion system', 'type': 'PROCEDURE', 'description': 'Standard trabeculectomy surgery', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 5G2', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Hotel Dieu Hospital, Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital, University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Robert J Campbell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Glaucoma Research & Education Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Robert Campbell', 'investigatorAffiliation': "Queen's University"}}}}