Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neovascular Glaucoma
Intervention: Glaucoma drainage implant with/without triamcinolone (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s): Augusto Paranhos Jr, PHD, Principal Investigator, Affiliation: Federal University of Sao Paulo
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.
Clinical Details
Official title: Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: intra ocular pressure after the surgery in both groups
Secondary outcome: complication rates after surgery
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:
1. Silicone Ahmed Implant
2. 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Federal University of Sao Paulo, Sao Paulo, SP 04023900, Brazil
Additional Information
Related publications: 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. Review.
Starting date: September 2005
Last updated: June 25, 2007
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