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NCT00238563 Clinical Trial

Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Glaucoma Clinical Trial

Official title:
Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00238563
Other study ID # 7/8/05-21
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated

Study information
Verified date April 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Triamcinolone injection, sub-tenon

Locations
Country Name City State
United States Santa Clara valley Medical Center San Jose California
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure
Secondary visual field progression, need for further surgery or medications
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