Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma
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
Run by Benha University · NCT07755761 · Data updated 2026-11-12
A randomized trial tests a new surgical method called ITT against standard trabeculectomy to see if it better lowers eye pressure with fewer medications and complications in adults with advanced or treatment-resistant glaucoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2028 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07755761 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced or refractory open-angle glaucoma, IOP > 21 mmHg on maximal tolerated medical therapy or after failed glaucoma surgery, BCVA 20/400 or better, and capacity to consent.
✕Probably not a fit
Patients with neovascular glaucoma, other forms of secondary glaucoma affecting wound healing, pregnancy, or prior incisional glaucoma surgery in the study eye (except certain prior trabeculectomy in refractory cases) may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized trial compares Innovative Tube Trabeculectomy (ITT) with conventional trabeculectomy in adults with advanced or refractory open-angle glaucoma. ITT uses a deep extended scleral tunnel, X-shaped non-absorbable sutures, and a nasolacrimal tube implant along with a preoperative regimen to boost outflow and reduce scarring. Participants are followed for 12 months to measure intraocular pressure, medication needs, complications, and bleb morphology using imaging and standard eye exams. Primary outcome is surgical success defined as IOP ≤ 15 mmHg with at least a 20% reduction from baseline without medications at 12 months. Secondary outcomes include mean IOP, medication burden, adverse events, visual function, and quality of life.
Why it matters
Potential benefit: If ITT proves safer and more effective, patients may experience better long-term eye pressure control with fewer medications.
How similar studies have gone: Previous attempts to improve trabeculectomy outcomes with modified techniques have shown mixed results; this trial tests a novel combination of surgical modifications.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Ophthalmology department, Faculty of Medicine, Benha University
Banhā, Egypt Recruiting
Study contacts
- Study coordinator: Ahmed M Saeed, MD
- Email: ahmed.abdelhamid@fmed.bu.edu.eg
- Phone: 01227468426
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.