Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

Status Withdrawn

Clinical Trial Summary

This study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application.

Clinical Trial Description

This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, patients from Menelik Hospital who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive mitomycin C applied topically or by injection during the surgery.At Menelik Hospital mitomycin-C (MMC) is routinely applied to the eye prior to trabeculectomy by physicians via both sponge and injection routes. The primary outcome is the patient's response to the trabeculectomy procedure, as measured by cumulative complications after a 3-month follow-up period post-operation. Secondary outcome is the change in intraocular pressure after a 3 month follow-up period. The investigators will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success. ;

Study Design

Related Conditions & MeSH terms

Glaucoma

Clinical Trial Details

NCT number	NCT02744690
Study type	Interventional
Source	University of California, San Francisco
Contact
Status	Withdrawn
Phase	N/A
Start date	March 1, 2015
Completion date	March 1, 2019

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