GlaucomaITT-RCTNCT07755761
Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial
A study testing Innovative Tube Trabeculectomy and Conventional Trabeculectomy in people with Glaucoma and Trabeculectomy, run by Benha University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy and safety of a novel surgical technique, Innovative Tube Trabeculectomy (ITT), against conventional trabeculectomy in patients with advanced and refractory glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Trabeculectomy, Innovative Procedures
- What is being tested?
- Innovative Tube Trabeculectomy and Conventional Trabeculectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- • Diagnosis of advanced or refractory primary open-angle glaucoma (POAG) or secondary open-angle glaucoma (excluding neovascular glaucoma).
- Intraocular pressure (IOP) > 21 mmHg despite maximal tolerated medical therapy or previous failed glaucoma surgery.
- Best corrected visual acuity (BCVA) of 20/400 or better.
- Capable of providing informed consent
Who cannot join
- Previous incisional glaucoma surgery in the study eye (except for prior failed trabeculectomy in the refractory group).
- Neovascular glaucoma or other forms of secondary glaucoma that may significantly impact wound healing (e.g., uveitic glaucoma).
- Significant ocular comorbidities that may confound outcome assessment (e.g., severe corneal disease, retinal detachment).
- Pregnancy or lactation.
- Participation in another clinical trial within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ophthalmology department, Faculty of Medicine, Benha University
Banhā, 13518
Mohamed G AlAshhab, MD, 0133227518, info@fmed.bu.edu.eg
Tarek Abulnasr, MD
About this study
Official title: A Prospective, Randomized, Controlled, Single-Center Clinical Trial to Evaluate the Efficacy and Safety of Innovative Tube Trabeculectomy Compared to Conventional Trabeculectomy in Patients With Advanced and Refractory Glaucoma
This study aims to compare the efficacy and safety of a novel surgical technique, Innovative Tube Trabeculectomy (ITT), against conventional trabeculectomy in patients with advanced and refractory glaucoma. ITT incorporates a unique preoperative regimen and surgical modifications, including a deep extended scleral tunnel, X-shaped non-absorbable suture, and a nasolacrimal tube implant, designed to enhance aqueous humor outflow and reduce postoperative fibrosis. Participants will be randomized to receive either ITT or conventional trabeculectomy and followed for 12 months to assess intraocular pressure control, medication use, complication rates, and bleb morphology.
Read the detailed description
Glaucoma is a leading cause of irreversible blindness. While trabeculectomy is a standard surgical intervention, its long-term success can be compromised by fibrosis. The ITT technique introduces several innovations to address these limitations. This single-center, prospective, randomized controlled trial will enroll adult patients with advanced or refractory open-angle glaucoma. Patients will undergo a rigorous preoperative regimen before being randomized to either the ITT group or the conventional trabeculectomy group. The primary outcome will be surgical success (IOP ≤ 15 mmHg and ≥ 20% reduction from baseline without medication) at 12 months. Secondary outcomes include mean IOP, medication burden, complication rates, bleb morphology (UBM/AS-OCT), visual acuity, visual fields, and quality of life. The study will provide crucial evidence on the potential benefits of ITT for this challenging patient population.
- Conditions
- Glaucoma, Trabeculectomy, Innovative Procedures
- Being tested
- Innovative Tube Trabeculectomy, Conventional Trabeculectomy
- Keywords
- glaucoma, innovative, tube trabeculectomy
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innovative Tube TrabeculectomyProcedure or surgery
Patients will undergo the innovative tube trabeculectomy procedure. This includes a 3-week preoperative regimen (discontinuation of preserved medications and prostaglandin analogs, initiation of fluorometholone), a 1-week preoperative subconjunctival injection (Mitomycin C 0.04%, Avastin 1.25 mg, Dexamethasone 8 mg), and the surgical technique involving a deep extended scleral tunnel, intraoperative Mitomycin C application, X-shaped non-absorbable suture, and nasolacrimal tube implantation.
Conventional TrabeculectomyProcedure or surgery
Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Innovative Tube Trabeculectomy (ITT) | Experimental | Patients will undergo the innovative tube trabeculectomy procedure. This includes a 3-week preoperative regimen (discontinuation of preserved medications and prostaglandin analogs, initiation of fluorometholone), a 1-week preoperative subconjunctival injection (Mitomycin C 0.04%, Avastin 1.25 mg, Dexamethasone 8 mg), and the surgical technique involving a deep extended scleral tunnel, intraoperative Mitomycin C application, X-shaped non-absorbable suture, and nasolacrimal tube implantation. Receives: Procedure: Innovative Tube Trabeculectomy |
| Arm 2: Conventional Trabeculectomy | Active comparator | Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site). Receives: Procedure: Conventional Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications.
The proportion of eyes achieving the defined surgical success criteria
Measured: 12 months post-surgery
Secondary outcomes (7)
• Measure: Mean Intraocular Pressure (IOP)
Average IOP measured at each follow-up visit.
Measured: • Time Frame: 3, 6, and 12 months post-surgery
• Measure: Number of Glaucoma Medications
Average number of glaucoma medications required to maintain target IOP.
Measured: 3, 6, and 12 months post-surgery
• Measure: Incidence of Surgical Complications
Rate and type of complications, including hypotony, bleb leakage, infection, tube exposure/migration, and choroidal detachment.
Measured: From surgery to 12 months post-surgery
• Measure: Bleb Morphology and Function
Assessment using Ultrasound Biomicroscopy (UBM) and Anterior Segment Optical Coherence Tomography (AS-OCT).
Measured: 6 and 12 months post-surgery
• Measure: Best Corrected Visual Acuity (BCVA)
Change in BCVA from baseline
Measured: 3, 6, and 12 months post-surgery
• Measure: Visual Field Mean Deviation (MD)
Change in visual field mean deviation from baseline
Measured: 6 and 12 months post-surgery
• Measure: Quality of Life (QoL)
Patient-reported outcomes using the NEI VFQ-25 questionnaire.
Measured: 6 and 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Saeed Abdel Hamid, Benha University
- Investigators
- Tarek Abulnasr, MD, Study director, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755761
- Sponsor's protocol ID
- Innovative Tube Trabeculectomy
- Acronym
- ITT-RCT
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What IPD will be shared? De-identified individual participant data that underlie the results reported in the final study, including demographic characteristics and ocular surface/meibomian gland assessment parameters. Supporting Documents: The study protocol and statistical analysis plan will be made available. When will data be available? Data will be available beginning 6 months and ending 36 months following the official publication of the study results. With whom? Data will be shared with qualified researchers who provide a methodologically sound proposal that is approved by the study investigators. For what types of analyses? To achieve the specific aims outlined in the approved research proposal. By what mechanism will data be made available? Interested researchers should contact the corresponding author via email to submit a formal request and a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Single-Center Clinical Trial to Evaluate the Efficacy and Safety of Innovative Tube Trabeculectomy Compared to Conventional Trabeculectomy in Patients With Advanced and Refractory Glaucoma
- ClinicalTrials.gov ID
- NCT07755761
- Acronym / sponsor ID
- ITT-RCT / Innovative Tube Trabeculectomy
- Conditions
- Glaucoma, Trabeculectomy, Innovative Procedures
- Keywords
- glaucoma, innovative, tube trabeculectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 10 Aug 2026 (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.
This study aims to compare the efficacy and safety of a novel surgical technique, Innovative Tube Trabeculectomy (ITT), against conventional trabeculectomy in patients with advanced and refractory glaucoma. ITT incorporates a unique preoperative regimen and surgical modifications, including a deep extended scleral tunnel, X-shaped non-absorbable suture, and a nasolacrimal tube implant, designed to enhance aqueous humor outflow and reduce postoperative fibrosis. Participants will be randomized to receive either ITT or conventional trabeculectomy and followed for 12 months to assess intraocular pressure control, medication use, complication rates, and bleb morphology.
Detailed description
Glaucoma is a leading cause of irreversible blindness. While trabeculectomy is a standard surgical intervention, its long-term success can be compromised by fibrosis. The ITT technique introduces several innovations to address these limitations. This single-center, prospective, randomized controlled trial will enroll adult patients with advanced or refractory open-angle glaucoma. Patients will undergo a rigorous preoperative regimen before being randomized to either the ITT group or the conventional trabeculectomy group. The primary outcome will be surgical success (IOP ≤ 15 mmHg and ≥ 20% reduction from baseline without medication) at 12 months. Secondary outcomes include mean IOP, medication burden, complication rates, bleb morphology (UBM/AS-OCT), visual acuity, visual fields, and quality of life. The study will provide crucial evidence on the potential benefits of ITT for this challenging patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Innovative Tube Trabeculectomy (ITT) | Experimental | Procedure: Innovative Tube TrabeculectomyPatients will undergo the innovative tube trabeculectomy procedure. This includes a 3-week preoperative regimen (discontinuation of preserved medications and prostaglandin analogs, initiation of fluorometholone), a 1-week preoperative subconjunctival injection (Mitomycin C 0.04%, Avastin 1.25 mg, Dexamethasone 8 mg), and the surgical technique involving a deep extended scleral tunnel, intraoperative Mitomycin C application, X-shaped non-absorbable suture, and nasolacrimal tube implantation. |
| Arm 2: Conventional Trabeculectomy | Active comparator | Procedure: Conventional TrabeculectomyPatients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Diagnosis of advanced or refractory primary open-angle glaucoma (POAG) or secondary open-angle glaucoma (excluding neovascular glaucoma).
- Intraocular pressure (IOP) > 21 mmHg despite maximal tolerated medical therapy or previous failed glaucoma surgery.
- Best corrected visual acuity (BCVA) of 20/400 or better.
- Capable of providing informed consent
Key exclusion criteria (5 listed)
- Previous incisional glaucoma surgery in the study eye (except for prior failed trabeculectomy in the refractory group).
- Neovascular glaucoma or other forms of secondary glaucoma that may significantly impact wound healing (e.g., uveitic glaucoma).
- Significant ocular comorbidities that may confound outcome assessment (e.g., severe corneal disease, retinal detachment).
- Pregnancy or lactation.
- Participation in another clinical trial within 30 days prior to enrollment.
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 |
|---|---|---|
| Innovative Tube TrabeculectomyPatients will undergo the innovative tube trabeculectomy procedure. This includes a 3-week preoperative regimen (discontinuation of preserved medications and prostaglandin analogs, initiation of fluorometholone), a 1-week preoperative subconjunctival injection (Mitomycin C 0.04%, Avastin 1.25 mg, Dexamethasone 8 mg), and the surgical technique involving a deep extended scleral tunnel, intraoperative Mitomycin C application, X-shaped non-absorbable suture, and nasolacrimal tube implantation. | Procedure or surgery | Arm 1: Innovative Tube Trabeculectomy (ITT) |
| Conventional TrabeculectomyPatients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site | Procedure or surgery | Arm 2: Conventional Trabeculectomy |
Primary outcome
• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications.
Time frame: 12 months post-surgery
The proportion of eyes achieving the defined surgical success criteria
7 secondary outcomes
• Measure: Mean Intraocular Pressure (IOP)
Time frame: • Time Frame: 3, 6, and 12 months post-surgery
• Measure: Number of Glaucoma Medications
Time frame: 3, 6, and 12 months post-surgery
• Measure: Incidence of Surgical Complications
Time frame: From surgery to 12 months post-surgery
• Measure: Bleb Morphology and Function
Time frame: 6 and 12 months post-surgery
• Measure: Best Corrected Visual Acuity (BCVA)
Time frame: 3, 6, and 12 months post-surgery
• Measure: Visual Field Mean Deviation (MD)
Time frame: 6 and 12 months post-surgery
• Measure: Quality of Life (QoL)
Time frame: 6 and 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. What IPD will be shared? De-identified individual participant data that underlie the results reported in the final study, including demographic characteristics and ocular surface/meibomian gland assessment parameters. Supporting Documents: The study protocol and statistical analysis plan will be made available. When will data be available? Data will be available beginning 6 months and ending 36 months following the official publication of the study results. With whom? Data will be shared with qualified researchers who provide a methodologically sound proposal that is approved by the study investigators. For what types of analyses? To achieve the specific aims outlined in the approved research proposal. By what mechanism will data be made available? Interested researchers should contact the corresponding author via email to submit a formal request and a data use agreement.
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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.
Tarek Abulnasr, MD study director
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovative Tube Trabeculectomy and Conventional Trabeculectomy in people with Glaucoma and Trabeculectomy, run by Benha 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Saeed, MD (01227468426, ahmed.abdelhamid@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications. (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.