Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial

NCT07755761 | Recruiting

• 1 other identifier: Innovative Tube Trabeculectomy
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Trabeculectomy; Glaucoma; Innovative Procedures

Keywords

glaucoma; innovative; tube trabeculectomy

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (7)

• • Measure: Mean Intraocular Pressure (IOP)

  • Time Frame: 3, 6, and 12 months post-surgery

• • Measure: Number of Glaucoma Medications

  3, 6, and 12 months post-surgery

• • Measure: Incidence of Surgical Complications

  From surgery to 12 months post-surgery

• • Measure: Bleb Morphology and Function

  6 and 12 months post-surgery

• • Measure: Best Corrected Visual Acuity (BCVA)

  3, 6, and 12 months post-surgery

Study Arms (2)

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.

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).

Procedure: Conventional Trabeculectomy

Interventions

Innovative Tube Trabeculectomy PROCEDURE

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.

Arm 1: Innovative Tube Trabeculectomy (ITT)

Conventional Trabeculectomy PROCEDURE

Patients will undergo standard conventional trabeculectomy with intraoperative Mitomycin C application (concentration and duration as per standard practice at the study site

Arm 2: Conventional Trabeculectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- • 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Ophthalmology department, Faculty of Medicine, Benha University

Banhā, 13518, Egypt

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Tarek Abulnasr, MD

  Benha University

  STUDY DIRECTOR

Central Study Contacts

Ahmed M Saeed, MD

CONTACT

01227468426; ahmed.abdelhamid@fmed.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding of participants and care providers is not feasible due to the nature of surgical interventions and distinct postoperative care protocols
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months and ending 36 months following the official publication of the study results.
• 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.

Locations

EG (1)