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NCT07755761
Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial
Conditions: Glaucoma, Trabeculectomy, Innovative Procedures
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 116
Sponsor: Benha University
Location: Ophthalmology department, Faculty of Medicine, Benha University Banhā
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT07755761). StuddyBuddy aggregates publicly available trial information.