NCT06925412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
Last Updated

April 13, 2025

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

April 6, 2025

Last Update Submit

April 6, 2025

Conditions

TrabeculectomyGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure (IOP) reduction

    One year

Secondary Outcomes (3)

  • Bleb morphology (Indiana Bleb Appearance Grading Scale)

    One year

  • Bleb integrity (Seidel test)

    One year

  • Postoperative glaucoma medication use

    One year

Study Arms (2)

MMC sponge application

EXPERIMENTAL
Procedure: MMC sponge application

Sub-Tenon MMC injection

EXPERIMENTAL
Procedure: Sub-tenon MMC injection

Interventions

MMC sponge applicationPROCEDURE

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

MMC sponge application
Sub-tenon MMC injectionPROCEDURE

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

Sub-Tenon MMC injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebsar Eye Center

Cairo, Egypt, 4450113, Egypt

Location

Related Publications (1)

  • Abdelhafeez SME, Mohammed Mohammed HE, Tharwat E, Ibrahim MM, Tawfik AMR, Elgohary RMA, Alabshihy MSI, Sakr AM, Ebrahim AM, Mohammed AR, Yusef NM, Saliem EA, Elsayed SSE, Elsayed Saad EM. Sponge Application of Mitomycin C vs Sub-Tenon Injection in Trabeculectomy: A Randomized Controlled Trial. J Curr Glaucoma Pract. 2025 Oct-Dec;19(4):199-207. doi: 10.5005/jp-journals-10078-1500. Epub 2025 Dec 15.

    PMID: 41523175DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Benha University, Egypt

Study Record Dates

First Submitted

April 6, 2025

First Posted

April 13, 2025

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

April 13, 2025

Record last verified: 2024-01

Locations

EG(1)