Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 5:35 AM
Study NCT ID:
NCT00854256
Status:
UNKNOWN
Last Update Posted:
2013-04-15
First Post:
2009-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trabeculectomy Versus Canaloplasty to Treat Glaucoma
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'}, {'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-04-12', 'studyFirstSubmitDate': '2009-03-02', 'studyFirstSubmitQcDate': '2009-03-02', 'lastUpdatePostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eye pressure', 'timeFrame': 'Within 12 month after surgery', 'description': 'Eye pressure is measured after 1 month, 2 months, 3 months, 6 months, 9 months, and 12 months after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate pressure lowering effect of two surgical methods canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local pressure lowering therapy the progression of the disease could not be stopped, and thus a pressure lowering surgical intervention is necessary. The risks in the postoperative course in Canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-C. Conversely, large glaucoma centers questioning the effectiveness of permanent pressure lowering of canaloplasty. Precisely this question is investigated in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with open angle glaucoma and excavation of 0.4 - 0.8\n* 60 eyes of 60 patients (30 patients for trabeculectomy, 30 patients for Canaloplasty) The ratio of female / male is not involved.\n* Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).\n* Local drug therapy: at least 2 eye pressure lowering ingredients or absolute intolerance to preservatives or eye drops.\n* general anesthesia possible.\n* The operation must be signed by the surgeon as a state-of-the-art performed without complication to be evaluated. If the operation does not meet this criterion, the patient is excluded from the study.\n\nExclusion Criteria:\n\n* all patients are not included in the group of inclusion criteria, or:\n* Phenprocoumon therapy.\n* operation is not done state-of-the-art.\n* after the surgery: additional eye pressure lowering surgery, cataract surgery, keratoplasty, laser surgery in the anterior eye segment (except suture lysis after trabeculectomy)\n* Uveitis, or possible inflammation of the eye\n* Previous eye pressure lowering operations or laser interventions\n* Corneal Refractive Surgery (pseudophakia allowed)'}, 'identificationModule': {'nctId': 'NCT00854256', 'briefTitle': 'Trabeculectomy Versus Canaloplasty to Treat Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Comparison of Canaloplasty and Trabeculectomy in Patients With Open Angle Glaucoma and Inadequate Local Eye Pressure Lowering Therapy - a Prospective, Randomized Study', 'orgStudyIdInfo': {'id': 'iScience-022-CG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canaloplasty', 'interventionNames': ['Procedure: Canaloplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trabeculectomy with mitomycin C', 'interventionNames': ['Procedure: Trabeculectomy with mitomycin C']}], 'interventions': [{'name': 'Canaloplasty', 'type': 'PROCEDURE', 'description': 'Canaloplasty surgery', 'armGroupLabels': ['Canaloplasty']}, {'name': 'Trabeculectomy with mitomycin C', 'type': 'PROCEDURE', 'description': 'Trabeculectomy with mitomycin C surgery', 'armGroupLabels': ['Trabeculectomy with mitomycin C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50924', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Centre of Ophthalmology, University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Gerhard Welsandt, MD', 'role': 'CONTACT', 'email': 'g.welsandt@uni-koeln.de', 'phone': '+49-221-478-0'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'collaborators': [{'name': 'iScience Interventional Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Gerhard Welsandt, MD', 'oldOrganization': 'University of Cologne'}}}}