Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neovascular Glaucoma |
Procedure: Glaucoma drainage implant with/without triamcinolone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection |
- intra ocular pressure after the surgery in both groups [ Time Frame: monthly ]
- complication rates after surgery [ Time Frame: monthly ]
| Enrollment: | 49 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | June 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Brazil | |
| Federal University of Sao Paulo | |
| Sao Paulo, SP, Brazil, 04023900 | |
| Principal Investigator: | Augusto Paranhos Jr, PHD | Federal University of Sao Paulo |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00491712 History of Changes |
| Other Study ID Numbers: | Glau00036 |
| Study First Received: | June 25, 2007 |
| Last Updated: | June 25, 2007 |
| Health Authority: | Brazil: National Committee of Ethics in Research Brazil: Ministry of Health Brazil: National Health Surveillance Agency |
Keywords provided by Federal University of São Paulo:
|
Glaucoma Neovascular Glaucoma Drainage implant devices Silicone Ahmed Tube Triamcinolone |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Neovascular Ocular Hypertension Eye Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013