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Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

Primary Purpose

Glaucoma

Status
Withdrawn
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Mitomycin-C (MMC)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Eye Disease, Intraocular Pressure, Visual Acuity, Trabeculectomy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Menelik II Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MMC Injection

MMC Sponge Application

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cumulative incidence of complications
Comparison of the cumulative incidence of complications between the treatment groups (MMC sponge and injection application) 3 months after surgery

Secondary Outcome Measures

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

Full Information

First Posted
February 11, 2016
Last Updated
July 27, 2023
Sponsor
University of California, San Francisco
Collaborators
Menelik II Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02744690
Brief Title
Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia
Official Title
Topical vs Injection Application of Mitomycin C Trabeculectomy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The necessary ethical approvals were not obtained in a timely manner.
Study Start Date
March 1, 2015 (Anticipated)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Menelik II Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Eye Disease, Intraocular Pressure, Visual Acuity, Trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MMC Injection
Arm Type
Experimental
Arm Description
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
Arm Title
MMC Sponge Application
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Mitomycin-C (MMC)
Intervention Description
Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital
Primary Outcome Measure Information:
Title
Cumulative incidence of complications
Description
Comparison of the cumulative incidence of complications between the treatment groups (MMC sponge and injection application) 3 months after surgery
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Cumulative incidence of complications
Description
Comparison of the cumulative incidence of complications between the treatment groups (sponge and injection application of MMC) 6 months and 12 months after surgery
Time Frame
6 and 12 months after surgery
Title
Reduction of intraocular pressure from baseline, mmHg
Description
The investigators will compare the reduction of IOP from baseline between the treatment groups at 3, 6, and 12 months after surgery
Time Frame
3, 6, and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy D Keenan, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menelik II Hospital
City
Addis Ababa
Country
Ethiopia

12. IPD Sharing Statement

Learn more about this trial

Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

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