Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy

Not Applicable

Completed

• Conditions: Trabeculectomy; Glaucoma

• Registration Number: NCT06925412
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-02-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-03-01
• Study First Submitted: 2025-04-06
• Study First Submitted QC: 2025-04-06
• Last Update Submitted: 2025-04-06
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP) reduction	One year

Secondary Outcome Measures

Name	Time	Method
Bleb morphology (Indiana Bleb Appearance Grading Scale)	One year
Bleb integrity (Seidel test)	One year
Postoperative glaucoma medication use	One year

Trial Locations

Locations (1)

Ebsar Eye Center; 🇪🇬 Cairo, Egypt