Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
Primary Purpose
Neovascular Glaucoma
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Glaucoma drainage implant with/without triamcinolone
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Glaucoma focused on measuring Glaucoma, Neovascular Glaucoma, Drainage implant devices, Silicone Ahmed Tube, Triamcinolone
Eligibility Criteria
Inclusion Criteria:
- Patients 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.
Exclusion Criteria:
- Active Sclerites
- Uveitic Neovascular glaucoma
- 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
Sites / Locations
- Federal University of Sao Paulo
Outcomes
Primary Outcome Measures
intra ocular pressure after the surgery in both groups
Secondary Outcome Measures
complication rates after surgery
Full Information
NCT ID
NCT00491712
First Posted
June 25, 2007
Last Updated
June 25, 2007
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00491712
Brief Title
Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
Official Title
Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
In the present study we will compare the outcome and complications of Silicone Ahmed Valve in GNV eyes with and without intra-vitreous triamcinolone injection.
Detailed Description
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.
In the present study we will compare the outcome and complications of Silicone Ahmed Valve in GNV eyes with and without intra-vitreous triamcinolone injection.
49 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:
Silicone Ahmed Implant
Silicone Ahmed Implant with intra-vitreous Triamcinolone injection
Inclusion Criteria:
Patients 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.
Exclusion Criteria:
Active 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
Surgery 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.
Follow up after surgery was in the 1st, 4th, 7th, 15th, 30th days and after that monthly or whenever needed for clinical reasons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Glaucoma
Keywords
Glaucoma, Neovascular Glaucoma, Drainage implant devices, Silicone Ahmed Tube, Triamcinolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Glaucoma drainage implant with/without triamcinolone
Primary Outcome Measure Information:
Title
intra ocular pressure after the surgery in both groups
Time Frame
monthly
Secondary Outcome Measure Information:
Title
complication rates after surgery
Time Frame
monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 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.
Exclusion Criteria:
Active Sclerites
Uveitic Neovascular glaucoma
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Augusto Paranhos Jr, PHD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
11581047
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.
Results Reference
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Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
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