Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy

Al-Azhar University

Status: Completed

Conditions: Trabeculectomy; Glaucoma

Treatments: Procedure: Sub-tenon MMC injection; Procedure: MMC sponge application

Study type: Interventional

Funder types: Other

Identifiers

NCT06925412

Ophth._27/2024Med.Research

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

MMC sponge application

Experimental group

Treatment:

Procedure: MMC sponge application

Sub-Tenon MMC injection

Experimental group

Treatment:

Procedure: Sub-tenon MMC injection