Glaucoma, Trabeculectomy
Conditions
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.
Interventions
PROCEDUREMMC 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
PROCEDURESub-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
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure (IOP) reduction | One year |
Secondary
| Measure | Time frame |
|---|---|
| Bleb morphology (Indiana Bleb Appearance Grading Scale) | One year |
| Bleb integrity (Seidel test) | One year |
| Postoperative glaucoma medication use | One year |
Countries
Egypt
Outcome results
None listed