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Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

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ClinicalTrials.gov Identifier: NCT00238563
Recruitment Status : Unknown
Verified August 2007 by Stanford University.
Recruitment status was:  Recruiting
First Posted : October 13, 2005
Last Update Posted : February 26, 2008
Sponsor:
Information provided by:
Stanford University

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

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Triamcinolone injection, sub-tenon Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery





Primary Outcome Measures :
  1. Intraocular pressure

Secondary Outcome Measures :
  1. visual field progression, need for further surgery or medications


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria:Trabeculectomy surgery patient, age 18 or older - Exclusion Criteria:Pregnant, nursing, age less than 18, known allergy to medication being studied

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): NCT00238563


Locations
United States, California
Santa Clara valley Medical Center Recruiting
San Jose, California, United States, 95128
Contact: Christopher J Engelman, MD    408-885-6770    engelman@stanford.edu   
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Christopher J Engelman, MD    408-885-6770    engelman@stanford.edu   
Principal Investigator: Christopher James Engelman         
Sponsors and Collaborators
Stanford University

ClinicalTrials.gov Identifier: NCT00238563     History of Changes
Other Study ID Numbers: 7/8/05-21
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: February 26, 2008
Last Verified: August 2007

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action