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Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

2016-04-20 18:23:22 | BioPortfolio

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.

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Glaucoma

Intervention

Mitomycin-C (MMC)

Location

Menelik II Hospital
Addis Ababa
Ethiopia

Status

Recruiting

Source

Francis I. Proctor Foundation

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-04-20T18:23:22-0400

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Medical and Biotech [MESH] Definitions

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An enediyne that alkylates DNA and RNA like MITOMYCIN does, so it is cytotoxic.

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