Official Title: “Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery”

Determine efficacy of sub tenon kenalog injections for post-operative management of trabeculectomy procedures.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Postoperative sub-Tenon Triamcinolone Acetonide in glaucoma filtering surgery

Objectives: Trabeculectomy is a surgical procedure designed to reduce internal eye pressure by draining fluid from within the eye to the sub-conjunctival (superficial eye lining) space.

Scar formation from conjunctival and Tenon's capsule fibroblast proliferation represents the most common cause of failure of trabeculectomies. A number of drugs have been use to prevent failure of trabeculectomies from the scarring process including intraoperative mitomycin C (MMC) and preoperative Triamcinalone Acetonide (TA). Over the past several years, intraoperative MMC has become a preferred method of preventing scar formation. This study looks to determine in a prospective, double-blind, randomized method the long-term efficacy and safety of MMC with postoperative TA compared to the standard practice of intraoperative MMC with postoperative prednisolone acetate drops in preventing scar related failures of trabeculectomies.

Intervention(s) in this Clinical Trial

• Drug: Triamcinolone injection, sub-tenon

Primary Measures

• Intraocular pressure

Secondary Measures

• visual field progression, need for further surgery or medications

• Inclusion Criteria:Trabeculectomy surgery patient, age 18 or older - Exclusion
• Criteria:Pregnant, nursing, age less than 18, known allergy to medication being studied

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stanford University

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00238563

Study ID Number: 7/8/05-21

ClinicalTrials.gov Identifier: NCT00238563

Health Authority: United States: Institutional Review Board