Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-18 @ 11:21 PM
Study NCT ID:
NCT00491712
Status:
UNKNOWN
Last Update Posted:
2007-06-26
First Post:
2007-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015355', 'term': 'Glaucoma, Neovascular'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-06-25', 'studyFirstSubmitDate': '2007-06-25', 'studyFirstSubmitQcDate': '2007-06-25', 'lastUpdatePostDateStruct': {'date': '2007-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intra ocular pressure after the surgery in both groups', 'timeFrame': 'monthly'}], 'secondaryOutcomes': [{'measure': 'complication rates after surgery', 'timeFrame': 'monthly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Neovascular Glaucoma', 'Drainage implant devices', 'Silicone Ahmed Tube', 'Triamcinolone'], 'conditions': ['Neovascular Glaucoma']}, 'referencesModule': {'references': [{'pmid': '11581047', 'type': 'BACKGROUND', 'citation': "Sivak-Callcott JA, O'Day DM, Gass JD, Tsai JC. Evidence-based recommendations for the diagnosis and treatment of neovascular glaucoma. Ophthalmology. 2001 Oct;108(10):1767-76; quiz1777, 1800. doi: 10.1016/s0161-6420(01)00775-8."}]}, 'descriptionModule': {'briefSummary': 'The management of neovascular glaucoma (NVG) is a challenge for the ophthalmologist and surgery is frequently needed to control IOP. The success rates of a drainage device is usually lower in NVG than in other forms of glaucoma. Triamcinolone intra-vitreous injections acetate has been used to treat macular edema secondary to diabetic retinopathy and central retinal vein occlusion and also to control inflammation in ophthalmologic surgeries.\n\nIn the present study we will compare the outcome and complications of Silicone Ahmed Valve in GNV eyes with and without intra-vitreous triamcinolone injection.', 'detailedDescription': "The management of neovascular glaucoma (NVG) is a challenge for the ophthalmologist and surgery is frequently needed to control intraocular pressure (IOP). The success rates of a drainage device is usually lower in NVG than in other forms of glaucoma. Triamcinolone intra-vitreous injections acetate has been used to treat macular edema secondary to diabetic retinopathy and central retinal vein occlusion and also to control inflammation in ophthalmologic surgeries.\n\nIn the present study we will compare the outcome and complications of Silicone Ahmed Valve in GNV eyes with and without intra-vitreous triamcinolone injection.\n\n49 Patients with clinically uncontrolled neovascular glaucoma were selected from the glaucoma sector of Federal university of Sao Paulo. After retinal panfotocoagulation (RPF), patients who still are uncontrolled are enrolled to the study. Patients were randomized to one of two groups:\n\n1. Silicone Ahmed Implant\n2. Silicone Ahmed Implant with intra-vitreous Triamcinolone injection\n\nInclusion Criteria:\n\nPatients with NVG and uncontrolled IOP despite the use of maximum tolerated glaucoma medication Patients over 18 years old. Patients who can understand and sign the inform consent form.\n\nExclusion Criteria:\n\nActive Sclerites Uveitic NVG Previous psiquiatric condition Patients who can understand and sign the inform consent form Visual acuity worse than hand motion Previous retina surgery with buckle implant\n\nSurgery description A fornix-based conjunctival flap was created between two adjacent recti muscles. Before placement of the tube implant body to the sclera, tube was irrigated with saline solution to open the valve mechanism. The implant's polypropylene body was sutured to sclera with 6.0 silk suture. The tube then trimmed and the anterior chamber was entered from 1mm posterior to corneoscleral limbus with 23-gauge needle. A human donor scleral flap was placed over the tube and sutured to the sclera with 10.0 nylon suture. The conjunctiva was sutured to the limbus. In the triamcinolone group, a intra-vitreous injection of 0,1mL triamcinolone acetate (40mg/ml) was performed with a 30-gauge needle.\n\nFollow up after surgery was in the 1st, 4th, 7th, 15th, 30th days and after that monthly or whenever needed for clinical reasons."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with NVG and uncontrolled IOP despite the use of maximum tolerated glaucoma medication\n* Patients over 18 years old.\n* Patients who can understand and sign the inform consent form.\n\nExclusion Criteria:\n\n* Active Sclerites\n* Uveitic Neovascular glaucoma\n* Previous psiquiatric condition\n* Patients who can understand and sign the inform consent form\n* Visual acuity worse than hand motion\n* Previous retina surgery with buckle implant'}, 'identificationModule': {'nctId': 'NCT00491712', 'briefTitle': 'Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection', 'orgStudyIdInfo': {'id': 'Glau00036'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Glaucoma drainage implant with/without triamcinolone', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Augusto Paranhos Jr, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}}}}