NCT07755761Recruiting
Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial
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
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 5 Aug 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- Benha University
- Diseases
- Glaucoma
- NCT number
- NCT07755761
What you commit to
- Study type: Interventional
- Planned participants: 116
- From 1 Aug 2026 to the primary completion date, 1 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous incisional glaucoma surgery in the study eye (except for prior failed trabeculectomy in the refractory group).
- Participation in another clinical trial within 30 days prior to enrollment.
Other illness
- Significant ocular comorbidities that may confound outcome assessment (e.g., severe corneal disease, retinal detachment).
Other
- Neovascular glaucoma or other forms of secondary glaucoma that may significantly impact wound healing (e.g., uveitic glaucoma).
- Pregnancy or lactation.
Who the study is looking for
- \- • 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ophthalmology department, Faculty of Medicine, Benha University Coordinator of this site? Confirm its status | Banhā | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.