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

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…

ClinicalTrials.gov IDNCT07755761

PhaseNA

Enrollment116

SponsorBenha University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Glaucoma, Trabeculectomy, Innovative Procedures

About this study

Interventions

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.
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

Primary outcomes

• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications. (12 months post-surgery)

Eligibility information

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 locations

Ophthalmology department, Faculty of Medicine, Benha University, Banhā, 13518 Egypt

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-03.