Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia

NCT02744690 | Withdrawn

• 1 other identifier: 15-16075-MMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Eye Disease; Intraocular Pressure; Visual Acuity; Trabeculectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cumulative incidence of complications

  6 and 12 months after surgery

• Reduction of intraocular pressure from baseline, mmHg

  3, 6, and 12 months after surgery

Study Arms (2)

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

Drug: Mitomycin-C (MMC)

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

Drug: Mitomycin-C (MMC)

Interventions

Mitomycin-C (MMC) DRUG

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

MMC Injection; MMC Sponge Application

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=40
• Planning to have a trabeculectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Menelik II Hospital: collaborator

Study Sites (1)

Menelik II Hospital

Addis Ababa, Ethiopia

Location

MeSH Terms

Conditions

Glaucoma; Eye Diseases

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Ocular Hypertension

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jeremy D Keenan, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: April 20, 2016
• Study Start: March 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

ET (1)