Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy

NCT ID: NCT06925412

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-03-01

Brief Summary

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.

Conditions

Trabeculectomy; Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MMC sponge application

Group Type: EXPERIMENTAL

MMC sponge application

Intervention Type: 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

Group Type: EXPERIMENTAL

Sub-tenon MMC injection

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Hazem Elbadry Mohammed Mohammed

Lecturer of Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Benha University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ebsar Eye Center

Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

Ophth._27/2024Med.Research

Identifier Type: -

Identifier Source: org_study_id