Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Topical vs Injection Application of Mitomycin C Trabeculectomy Trial

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Mitomycin-C (MMC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMC Injection<br>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)<br>* Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital<br>|
| Active Comparator: MMC Sponge Application<br>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)<br>* Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of complications | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye Disease, Intraocular Pressure, Visual Acuity, Trabeculectomy