Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial (NCT07755761) | Clinical Trial Compass
RecruitingNot Applicable
Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial
Egypt116 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
• Measure: Surgical success, defined as Intraocular Pressure (IOP) ≤ 15 mmHg and ≥ 20% reduction from baseline without glaucoma medications.