Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy

April 6, 2025 updated by: Hazem Elbadry Mohammed Mohammed, Al-Azhar University

Glaucoma is a leading cause of irreversible blindness worldwide, with intraocular pressure (IOP) reduction being the primary therapeutic goal. Trabeculectomy, augmented with mitomycin C (MMC), remains the gold standard surgical intervention but is limited by postoperative fibrosis. MMC delivery methods, including sponge application and sub-Tenon injection, vary in drug distribution and may influence surgical outcomes. This study aimed to compare the efficacy and safety of trabeculectomy using sponge-applied MMC versus sub-Tenon MMC injection, focusing on IOP reduction, bleb morphology, and postoperative medication requirements.

In this retrospective, randomized controlled trial, 50 patients with primary or secondary glaucoma were assigned to trabeculectomy with either MMC sponge application (Group A, n=25) or sub-Tenon MMC injection (Group B, n=25). All surgeries were performed by the same surgeon using standardized techniques. Patients were followed for one year, with primary outcomes including IOP reduction and secondary outcomes encompassing bleb morphology (Indiana Bleb Appearance Grading Scale), bleb integrity (Seidel test), and postoperative glaucoma medication use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 4450113
        • Ebsar Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older,
  • diagnosed with primary open-angle glaucoma (POAG) or secondary glaucoma,
  • uncontrolled IOP (IOP > 21 mmHg) despite maximally tolerated medical therapy,
  • progressive visual field deterioration,
  • or intolerance to anti-glaucoma medications.

Exclusion Criteria:

  • age under 18 years,
  • absence of light perception,
  • previous incisional glaucoma surgery,
  • need for combined ocular procedures,
  • intraoperative use of 5-fluorouracil (5-FU),
  • or follow-up duration of less than one month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MMC sponge application
Procedure: MMC sponge application
Three micro swabs soaked in 0.03% MMC were subconjunctivally applied, followed by the creation of a fornix-based conjunctival flap. Subsequently, the standard trabeculectomy procedure was initiated without additional irrigation of the MMC application site
Experimental: Sub-Tenon MMC injection
Procedure: Sub-tenon MMC injection
MMC was administered via a sub-tenon injection. A 30-gauge needle was inserted into the conjunctiva and carefully advanced laterally along Tenon's capsule. A cannula was employed to minimize the excessive spread of MMC over the anticipated conjunctival incision site. After MMC delivery, a fornix-based conjunctival peritomy was performed, and both groups proceeded to undergo standard trabeculectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure (IOP) reduction
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleb morphology (Indiana Bleb Appearance Grading Scale)
Time Frame: One year
One year
Bleb integrity (Seidel test)
Time Frame: One year
One year
Postoperative glaucoma medication use
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2025

Last Update Submitted That Met QC Criteria

April 6, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ophth._27/2024Med.Research

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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