Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

University of California San Francisco (UCSF)

Status: Withdrawn

Conditions: Glaucoma

Treatments: Drug: Mitomycin-C (MMC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02744690

15-16075-MMC

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

MMC Injection

Experimental group

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

Treatment:

Drug: Mitomycin-C (MMC)

MMC Sponge Application

Active Comparator group

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

Treatment:

Drug: Mitomycin-C (MMC)