Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

NCT ID: NCT02744690

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2019-03-01

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Mitomycin-C (MMC)

Intervention Type: DRUG

Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital

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

Group Type: ACTIVE_COMPARATOR

Mitomycin-C (MMC)

Intervention Type: DRUG

Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital

Interventions

Mitomycin-C (MMC)

Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menelik II Hospital

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy D Keenan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Menelik II Hospital

Addis Ababa, , Ethiopia

Countries

Ethiopia

Other Identifiers

15-16075-MMC

Identifier Type: -

Identifier Source: org_study_id