NCT07755761 Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial
| NCT ID | NCT07755761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Benha University |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 116 participants in total. It began in 2026-08-01 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Tarek Abulnasr, MD
STUDY DIRECTOR
Benha University
Frequently Asked Questions
Who can join the NCT07755761 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07755761 currently recruiting?
Yes, NCT07755761 is actively recruiting participants. Contact the research team at ahmed.abdelhamid@fmed.bu.edu.eg for enrollment information.
Where is the NCT07755761 trial being conducted?
This trial is being conducted at Banhā, Egypt.
Who is sponsoring the NCT07755761 clinical trial?
NCT07755761 is sponsored by Benha University. The principal investigator is Tarek Abulnasr, MD at Benha University. The trial plans to enroll 116 participants.