Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01115218
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2010-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-16', 'studyFirstSubmitDate': '2010-05-03', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma'], 'conditions': ['Glaucoma', 'Trabeculectomy', 'Wound Healing']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate whether it is possible to predict the success of trabeculectomy in patients with glaucoma through the examination of mediators of wound healing in anterior chamber fluid. The success rate of trabeculectomy with mitomycin C in the literature is about 75%. This leads on the question why 25% of the patients received trabeculectomy are not sufficient treated and have not a long-term IOP reduction. Precisely this question is to be examined by the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the University Eye Hospital of Cologne', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with glaucoma with a trabeculectomy required\n* 60 eyes of 60 patients, The ratio of female / male is not involved.\n* Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).\n* age of at least 18 years\n\nExclusion Criteria:\n\n* all patients not included in the group of inclusion criteria.\n* less than 50yl anterior chamber fluid could be collected during the operation.'}, 'identificationModule': {'nctId': 'NCT01115218', 'briefTitle': 'The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy', 'orgStudyIdInfo': {'id': 'MeVeTra-2009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Glaucoma patients', 'interventionNames': ['Procedure: Trabeculectomy']}], 'interventions': [{'name': 'Trabeculectomy', 'type': 'PROCEDURE', 'description': 'Trabeculectomy with mitomycin C', 'armGroupLabels': ['Glaucoma patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Eye Hospital, University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Arno Hueber', 'investigatorFullName': 'Arno Hueber', 'investigatorAffiliation': 'University of Cologne'}}}}