Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenha University
About this 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 or conventional trabeculectomy and followed for 12 months to assess intraocular pressure control, medication use, complication rates, and bleb morphology.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Innovative Tube Trabeculectomy
- Conventional Trabeculectomy
Treatment groups
116 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov