Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial (ITT-RCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Trabeculectomy; Innovative Procedures
• Intervention / Treatment: Procedure: Innovative Tube Trabeculectomy; Procedure: Conventional Trabeculectomy

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 Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed M Saeed, MD; Phone Number: 01227468426; Email: ahmed.abdelhamid@fmed.bu.edu.eg

Study Locations

• Egypt
  • Banhā, Egypt, 13518
    • Recruiting
    • Ophthalmology department, Faculty of Medicine, Benha University
    • Contact: Mohamed G AlAshhab, MD; Phone Number: 0133227518; Email: info@fmed.bu.edu.eg
    • Sub-Investigator: Tarek Abulnasr, MD
    • Principal Investigator: Ahmed M Saeed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- • 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Innovative Tube Trabeculectomy (ITT); 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.	Procedure: Innovative Tube Trabeculectomy; 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.
Active Comparator: Arm 2: Conventional Trabeculectomy; Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site).	Procedure: Conventional Trabeculectomy; Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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	12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Measure: Mean Intraocular Pressure (IOP)	Average IOP measured at each follow-up visit.	• Time Frame: 3, 6, and 12 months post-surgery
• Measure: Number of Glaucoma Medications	Average number of glaucoma medications required to maintain target IOP.	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.	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).	6 and 12 months post-surgery
• Measure: Best Corrected Visual Acuity (BCVA)	Change in BCVA from baseline	3, 6, and 12 months post-surgery
• Measure: Visual Field Mean Deviation (MD)	Change in visual field mean deviation from baseline	6 and 12 months post-surgery
• Measure: Quality of Life (QoL)	Patient-reported outcomes using the NEI VFQ-25 questionnaire.	6 and 12 months post-surgery

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Study Director: Tarek Abulnasr, MD, Benha University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 5, 2026
• First Submitted That Met QC Criteria: August 5, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 5, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: glaucoma; innovative; tube trabeculectomy
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: Innovative Tube Trabeculectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will be available beginning 6 months and ending 36 months following the official publication of the study results.

IPD Sharing Access Criteria

Data will be shared with qualified researchers who provide a methodologically sound proposal that is approved by the study investigators.

Interested researchers should contact the corresponding author via email to submit a formal request and a data use agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No