Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 5:12 AM
Study NCT ID:
NCT00193960
Status:
UNKNOWN
Last Update Posted:
2005-12-01
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Results of Ahmed Valve Operations
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': 'D014792', 'term': 'Visual Acuity'}], 'ancestors': [{'id': 'D014787', 'term': 'Vision Tests'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009799', 'term': 'Ocular Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '1997-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-09', 'completionDateStruct': {'date': '2005-06'}, 'lastUpdateSubmitDate': '2005-11-29', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2005-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Seton surgery, glaucoma, Ahmed valve, intraocular pressure'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '18711462', 'type': 'DERIVED', 'citation': 'Rachmiel R, Trope GE, Buys YM, Flanagan JG, Chipman ML. Ahmed glaucoma valve implantation in uveitic glaucoma versus open-angle glaucoma patients. Can J Ophthalmol. 2008 Aug;43(4):462-7. doi: 10.3129/i08-082.'}]}, 'descriptionModule': {'briefSummary': 'Glaucoma drainage devices are usually placed in the superior quadrants. The superotemporal quadrant is usually the site of choice. However, when the upper fornix is scarred and especially when conjunctiva is two fibrotic to enable adequate coverage of tube with a scleral or other patch graft, some surgeons place the tube in one of inferior quadrants.', 'detailedDescription': 'Glaucoma drainage devices are usually placed in the superior quadrants. The superotemporal quadrant is usually the site of choice. However, when the upper fornix is scarred and especially when conjunctiva is two fibrotic to enable adequate coverage of tube with a scleral or other patch graft, some surgeons place the tube in one of inferior quadrants.\n\nIn the present study we will compare the outcome and complicatons of both the superior and the inferior approach for inserting Ahmed Valve implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients at the ages of 20-85 on the date of the surgery\n2. The indication for the surgery was: uncontrolled glaucoma with maximally tolerated medical therapy who did not or were not expected to respond to other surgical procedures than seton surgery.\n3. Visual acuity of, at least, 20/800 before the operation.\n4. Regular post operative follow ups, for at least 1 year.\n5. Patients after corneal transplantation for whom the indication of valve implantation was uncontrolled glaucoma.\n\nExclusion Criteria:\n\n1. A previous seton surgery in the operated eye\n2. Uveitic glaucoma patients or history of uveitis in the operated or in the fellow eye.\n3. Any inflammatory or ocular surface disease that could affect the healing of the conjunctiva after the surgery ( e.g: OCP)\n4. Strabismus or complains of diplopia prior to the seton surgery.\n5. Past history of retinal detachment surgery with scleral buckle in the operated eye\n6. Past history of endophthalmitis in the operated eye.'}, 'identificationModule': {'nctId': 'NCT00193960', 'briefTitle': 'The Results of Ahmed Valve Operations', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Comparison Between Superior and Inferior Ahmed Glaucoma Valve Implantation: Surgical Success and Complications', 'orgStudyIdInfo': {'id': 'In process'}}, 'armsInterventionsModule': {'interventions': [{'name': '1) Intraocular pressure 2) visual acuity', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rony Rachmiel, MD', 'role': 'CONTACT', 'email': 'rachmiel_r@hotmail.com', 'phone': '416-603-5317'}, {'name': 'Graham E Trope, MB, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rony Rachmiel, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yvonne M Buys, M.D., FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Flanagan John, Phd', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Ophthalmology and visual sciences, Toronto Western Hospital,', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Rony Rachmiel, M.D.', 'role': 'CONTACT', 'email': 'rachmiel_r@hotmail.com', 'phone': '416-603-5317'}], 'overallOfficials': [{'name': 'Trope E Graham, MB, FRCSC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Toronto, Department of Ophthalmology'}, {'name': 'Rony Rachmiel, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Toronto, Department of Ophthalmology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}}}}