Overview

This trial is active, not recruiting.

Condition neovascular glaucoma
Treatment glaucoma drainage implant with/without triamcinolone
Sponsor Federal University of São Paulo
Start date September 2005
End date June 2007
Trial size 49 participants
Trial identifier NCT00491712, Glau00036

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
intra ocular pressure after the surgery in both groups
time frame: monthly

Secondary Outcomes

Measure
complication rates after surgery
time frame: monthly

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
Principal investigator Augusto Paranhos Jr, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2007.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.