Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

July 27, 2023 updated by: University of California, San Francisco

Topical vs Injection Application of Mitomycin C Trabeculectomy Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Addis Ababa, Ethiopia
        • Menelik II Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >=40
  • Planning to have a trabeculectomy

Exclusion Criteria:

  • Life threatening or debilitating disease
  • Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
  • Pseudophakic lens
  • Contralateral eye already enrolled in study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MMC Injection
Intervention: At the intended surgical site and about 6mm from the limbus, 0.2ml of 0.2mg/ml of mitomycin-C (MMC) will be injected subconjunctivally before peritomy
Drug: Mitomycin-C (MMC)
Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital
Active Comparator: MMC Sponge Application
Intervention: After peritomy, three half-sponges soaked in 0.2mg/ml mitomycin-C (MMC) will be placed posterior to the area of intended filtration. After 2 minutes, the sponges will be removed
Drug: Mitomycin-C (MMC)
Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of complications
Time Frame: 3 months after surgery
Comparison of the cumulative incidence of complications between the treatment groups (MMC sponge and injection application) 3 months after surgery
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of complications
Time Frame: 6 and 12 months after surgery
Comparison of the cumulative incidence of complications between the treatment groups (sponge and injection application of MMC) 6 months and 12 months after surgery
6 and 12 months after surgery
Reduction of intraocular pressure from baseline, mmHg
Time Frame: 3, 6, and 12 months after surgery
The investigators will compare the reduction of IOP from baseline between the treatment groups at 3, 6, and 12 months after surgery
3, 6, and 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Menelik II Hospital

Investigators

  • Principal Investigator: Jeremy D Keenan, MD, MPH, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2015

Primary Completion (Estimated)

March 1, 2019

Study Completion (Estimated)

March 1, 2019

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

April 16, 2016

First Posted (Estimated)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-16075-MMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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