NCT06925412Completed
Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy
Source: ClinicalTrials.gov · Last updated 13 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 6 Apr 2025
- Start date
- 1 Feb 2024
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- Al-Azhar University
- Diseases
- Glaucoma
- NCT number
- NCT06925412
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 1 Feb 2024 to the primary completion date, 1 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous incisional glaucoma surgery,
Age
- age under 18 years,
Other
- absence of light perception,
- need for combined ocular procedures,
- intraoperative use of 5-fluorouracil (5-FU),
- or follow-up duration of less than one month
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ebsar Eye Center Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
Related publications
- Sponge Application of Mitomycin C vs Sub-Tenon Injection in Trabeculectomy: A Randomized Controlled Trial.J Curr Glaucoma Pract · 2025 · PMID 41523175
This page is information, not medical advice. Discuss any trial with your doctor.