Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2026-01-04 @ 5:05 PM
Study NCT ID:
NCT01741961
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2012-11-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Outcome After Ahmed Glaucoma Valve
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2012-11-22', 'studyFirstSubmitQcDate': '2012-12-03', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'reduction of glaucoma medication', 'timeFrame': '4 years', 'description': 'The number of glaucoma medication after Ahmed glaucoma valve implantation are being examined over a period of 4 years.'}, {'measure': 'postoperative complications', 'timeFrame': '4 years', 'description': 'Possible postoperative complications after Ahmed glaucoma valve implantation are being examined over a period of 4 years.'}, {'measure': 'need for revision operation', 'timeFrame': '4 years', 'description': 'The need for revision operations after Ahmed glaucoma valve implantation is being examined over a period of 4 years.'}], 'primaryOutcomes': [{'measure': 'intraocular pressure reduction', 'timeFrame': '4 years', 'description': 'The reduction of intraocular pressure after Ahmed glaucoma valve implantation is observed over a period of 4 years.'}], 'secondaryOutcomes': [{'measure': 'development of visual acuity', 'timeFrame': '4 years', 'description': 'The development of visual acuity after Ahmed glaucoma valve implantation is being examined over a period of 4 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['uncontrolled glaucoma', 'glaucoma drainage device'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.', 'detailedDescription': 'The development of intraocular pressure, visual acuity, number of glaucoma medication, number of complications and necessity of revision operations after Ahmed glaucoma valve implantation for uncontrolled glaucoma is examined yearly for a period of 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from uncontrolled glaucoma, most often after multiple ocular surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from medically uncontrolled glaucoma\n* Informed consent\n\nExclusion Criteria:\n\n* healthy subjects\n* under 18 years'}, 'identificationModule': {'nctId': 'NCT01741961', 'briefTitle': 'Long Term Outcome After Ahmed Glaucoma Valve', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': '4-year Follow-up After Ahmed Glaucoma Valve Implantation for Lowering Intraocular Pressure in Different Types of Glaucoma', 'orgStudyIdInfo': {'id': 'Ahmed-LTO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'glaucoma, surgery, Ahmed valve', 'description': 'Patients with uncontrolled glaucoma undergoing Ahmed glaucoma valve implantation for intraocular pressure reduction.', 'interventionNames': ['Procedure: Ahmed valve']}], 'interventions': [{'name': 'Ahmed valve', 'type': 'PROCEDURE', 'description': 'The flexible plate 7 (FP7) model (New World Medical) was implanted in patients with uncontrolled glaucoma.', 'armGroupLabels': ['glaucoma, surgery, Ahmed valve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'University Eye Clinic Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Karin R Pillunat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Dresden, Eye Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Karin Pillunat', 'investigatorAffiliation': 'Technische Universität Dresden'}}}}