TrabeculectomyNCT06925412
Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy
A study testing MMC sponge application and Sub-tenon MMC injection in people with Trabeculectomy and Glaucoma, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trabeculectomy, Glaucoma
- What is being tested?
- MMC sponge application and Sub-tenon MMC injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Trabeculectomy, Glaucoma
- Being tested
- MMC sponge application, Sub-tenon MMC injection
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMC sponge applicationProcedure or surgery
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
Sub-tenon MMC injectionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| MMC sponge application | Experimental | Not described Receives: Procedure: MMC sponge application |
| Sub-Tenon MMC injection | Experimental | Not described Receives: Procedure: Sub-tenon MMC injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP) reduction
Measured: One year
Secondary outcomes (3)
Bleb morphology (Indiana Bleb Appearance Grading Scale)
Measured: One year
Bleb integrity (Seidel test)
Measured: One year
Postoperative glaucoma medication use
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrabeculectomyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Elbadry Mohammed Mohammed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925412
- Sponsor's protocol ID
- Ophth._27/2024Med.Research
- Status last verified
- Jan 2024
- First submitted
- 6 Apr 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41523175
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy
- ClinicalTrials.gov ID
- NCT06925412
- Acronym / sponsor ID
- Ophth._27/2024Med.Research
- Conditions
- Trabeculectomy, Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMC sponge application | Experimental | Procedure: MMC sponge application |
| Sub-Tenon MMC injection | Experimental | Procedure: Sub-tenon MMC injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- age under 18 years,
- absence of light perception,
- previous incisional glaucoma surgery,
- need for combined ocular procedures,
- intraoperative use of 5-fluorouracil (5-FU),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMC sponge applicationThree 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 | Procedure or surgery | MMC sponge application |
| Sub-tenon MMC injectionMMC 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 | Procedure or surgery | Sub-Tenon MMC injection |
Primary outcome
Intraocular pressure (IOP) reduction
Time frame: One year
3 secondary outcomes
Bleb morphology (Indiana Bleb Appearance Grading Scale)
Time frame: One year
Bleb integrity (Seidel test)
Time frame: One year
Postoperative glaucoma medication use
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Derived from this study: PubMed 41523175Abdelhafeez 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.
- Individual participant dataSharing planned: Undecided
Related trials for Trabeculectomy
Not yet recruiting
Trabeculectomy Versus MicroShunt Implantation in Glaucoma Surgery (TIGER)
Glaucoma
Enrolling by invitation
Direct vs. Conventional SLT in Open-Angle Glaucoma: A RCT
GLAUCOMA 1, OPEN ANGLE, D (Disorder)
Active, not recruitingObservational study
Eye Pressure Lowering Surgery
Glaucoma
Active, not recruiting
Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population
Primary Open Angle Glaucoma, Ocular Hypertension
RecruitingPhase 3
Clarifying the Optimal Application of SLT Therapy Trial
Glaucoma and Ocular Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMC sponge application and Sub-tenon MMC injection in people with Trabeculectomy and Glaucoma, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (IOP) reduction (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06925412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.