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Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection

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ClinicalTrials.gov Identifier: NCT00491712
Recruitment Status : Unknown
Verified March 2007 by Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2007
Last Update Posted : June 26, 2007
Sponsor:
Information provided by:
Federal University of São Paulo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Neovascular Glaucoma Procedure: Glaucoma drainage implant with/without triamcinolone Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves With and Without Intravitreal Triamcinolone Injection
Study Start Date : September 2005
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. intra ocular pressure after the surgery in both groups [ Time Frame: monthly ]

Secondary Outcome Measures :
  1. complication rates after surgery [ Time Frame: monthly ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491712


Locations
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Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023900
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Augusto Paranhos Jr, PHD Federal University of Sao Paulo
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00491712    
Other Study ID Numbers: Glau00036
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: June 26, 2007
Last Verified: March 2007
Keywords provided by Federal University of São Paulo:
Glaucoma
Neovascular Glaucoma
Drainage implant devices
Silicone Ahmed Tube
Triamcinolone
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Triamcinolone
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs