Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

Not Applicable

Withdrawn

• Conditions: Glaucoma
• Interventions: Drug: Mitomycin-C (MMC)

• Registration Number: NCT02744690
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2015-03-01
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-04-16
• Study First Posted: 2016-04-20
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMC Injection	Mitomycin-C (MMC)	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	Mitomycin-C (MMC)	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of complications	6 and 12 months after surgery	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	3, 6, and 12 months after surgery	The investigators will compare the reduction of IOP from baseline between the treatment groups at 3, 6, and 12 months after surgery

Trial Locations

Locations (1)

Menelik II Hospital; 🇪🇹 Addis Ababa, Ethiopia