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Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00238563
Recruitment Status : Withdrawn (Funding not secured)
First Posted : October 13, 2005
Last Update Posted : April 14, 2023
Sponsor:
Information provided by:
Stanford University

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Intraocular pressure

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

Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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
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United States, California
Santa Clara valley Medical Center
San Jose, California, United States, 95128
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
More Information
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ClinicalTrials.gov Identifier: NCT00238563    
Other Study ID Numbers: 7/8/05-21
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: April 14, 2023
Last Verified: April 2023
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Triamcinolone
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs