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Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Post-Operative Sub-Tenon Kenalog in Glaucoma Filtering Surgery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00238563
Enrollment
0
Registered
2005-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

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.

Interventions

DRUGTriamcinolone injection, sub-tenon

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Trabeculectomy surgery patient, age 18 or older -

Exclusion criteria

Pregnant, nursing, age less than 18, known allergy to medication being studied

Design outcomes

Primary

MeasureTime frame
Intraocular pressure

Secondary

MeasureTime frame
visual field progression, need for further surgery or medications

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026