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Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00238563
First received: October 11, 2005
Last updated: February 22, 2008
Last verified: August 2007
History of Changes
  Purpose

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


Condition Intervention
Glaucoma
 Drug: Triamcinolone injection, sub-tenon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Intraocular pressure

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

Estimated Enrollment: 200
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00238563     History of Changes
Other Study ID Numbers: 7/8/05-21
Study First Received: October 11, 2005
Last Updated: February 22, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Glaucoma
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 June 18, 2013