Trial | NCT02744690  Report issue

Title

Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia
Topical vs Injection Application of Mitomycin C Trabeculectomy Trial

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Intervention/Treatment

    mitomycin ...

  • Study Participants

    0
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.
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 Started
Mar 01
2015
Anticipated
Primary Completion
Mar 01
2019
Anticipated
Study Completion
Mar 01
2019
Anticipated
Last Update
Aug 01
2023

Drug Mitomycin-C (MMC)

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

MMC Injection Experimental

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

MMC Sponge Application Active Comparator

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

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
No Results Posted