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Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Not Applicable
Withdrawn
Conditions
Glaucoma
Registration Number
NCT00238563
Lead Sponsor
Stanford University
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Trabeculectomy surgery patient, age 18 or older -

Exclusion Criteria

Pregnant, nursing, age less than 18, known allergy to medication being studied

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Intraocular pressure
Secondary Outcome Measures
NameTimeMethod
visual field progression, need for further surgery or medications

Trial Locations

Locations (2)

Stanford University School of Medicine

🇺🇸

Stanford, California, United States

Santa Clara valley Medical Center

🇺🇸

San Jose, California, United States

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