Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

• ClinicalTrials.gov Identifier: NCT00238563
• Recruitment Status: Withdrawn
• First Posted: October 13, 2005
• Last Update Posted: April 14, 2023
• Sponsor: Stanford University
• Information provided by: Stanford University

Tracking Information

• First Submitted Date: October 11, 2005
• First Posted Date: October 13, 2005
• Last Update Posted Date: April 14, 2023
• Study Start Date: Not Provided
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: October 11, 2005): Intraocular pressure
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 11, 2005): visual field progression, need for further surgery or medications
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery
• Official Title: Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Glaucoma
• Intervention: Drug: Triamcinolone injection, sub-tenon
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: September 9, 2019): 0
• Original Enrollment (submitted: October 11, 2005): 200
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided
• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00238563
• Other Study ID Numbers: 7/8/05-21
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Stanford University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Stanford University
• Verification Date: April 2023