Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial
Recruiting now · Not applicable
Conditions studied: Glaucoma, Trabeculectomy, Innovative Procedures
In brief
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.
Key facts
- Study ID
- NCT07755761
- Run by
- Benha University
- People needed
- 116
- Starts
- 2026-08-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Ophthalmology department, Faculty of Medicine, Benha University — Banhā, Egypt (enrolling)
Full record on ClinicalTrials.gov
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