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Completed

NCT Number: NCT06925412

Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy

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.

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Key information

Conditions

Trabeculectomy Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ebsar Eye Center

Cairo, Egypt, 4450113

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMC sponge application

Procedure

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

Sub-tenon MMC injection

Procedure

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

Primary outcomes

  1. Intraocular pressure (IOP) reduction

    Time frame: One year

Secondary outcomes

  1. Bleb morphology (Indiana Bleb Appearance Grading Scale)

    Time frame: One year

  2. Bleb integrity (Seidel test)

    Time frame: One year

  3. Postoperative glaucoma medication use

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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