Back to resultsPost-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery
Primary Purpose
Glaucoma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone injection, sub-tenon
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:Trabeculectomy surgery patient, age 18 or older - Exclusion Criteria:Pregnant, nursing, age less than 18, known allergy to medication being studied
Sites / Locations
- Santa Clara valley Medical Center
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
Intraocular pressure
Secondary Outcome Measures
visual field progression, need for further surgery or medications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00238563
Brief Title
Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery
Official Title
Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not secured
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Triamcinolone injection, sub-tenon
Primary Outcome Measure Information:
Title
Intraocular pressure
Secondary Outcome Measure Information:
Title
visual field progression, need for further surgery or medications
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Trabeculectomy surgery patient, age 18 or older - Exclusion Criteria:Pregnant, nursing, age less than 18, known allergy to medication being studied
Facility Information:
Facility Name
Santa Clara valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery
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