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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00491712
First received: June 25, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • intra ocular pressure after the surgery in both groups [ Time Frame: monthly ]

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

Enrollment: 49
Study Start Date: September 2005
Estimated Study Completion Date: June 2007
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491712

Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023900
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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 September 16, 2014