NCT07359547 Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt
| NCT ID | NCT07359547 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | GLAUCOMA 1, OPEN ANGLE, D (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-01 |
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 166 participants in total. It began in 2026-01-01 with a primary completion date of 2027-01.
⚠ 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
The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the XEN®-63 Gel Stent in reducing IOP after surgery.  The main questions it aims to answer are: * Does the PRESERFLO™ MicroShunt provide IOP reduction at 12 months that is non-inferior to the XEN®-63 Gel Stent? * How do the two devices compare over 24 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures? Participants will: * Be randomly assigned (1:1) to receive either the XEN®-63 Gel Stent or the PRESERFLO™ MicroShunt during a single glaucoma surgery. * Attend scheduled follow-up visits over 24 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments. * Receive standard postoperative care and report any complications or additional treatments during the study period.
Eligibility Criteria
Inclusion Criteria: * \>40 years of age * An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEX) * Inadequately controlled on maximum tolerated medical therapy. * Mean Deviation (MD) \</= -3 * Intraocular pressure of 14-28 mmHg * Endothelial Cell Count ≥1000 cells/mm2 Exclusion Criteria: * An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX) * Lens status: Aphakic patients or Anterior chamber intraocular lens * Previous procedures: Glaucoma shunt/valve/ surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months. * Presence of intraocular silicone oil * No light perception vision * Current corticosteroid use (ocular or oral) * Conjunctival pathologies (e.g., pterygium) * Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) * Vitreous present in the anterior chamber * Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date * Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07359547 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying GLAUCOMA 1, OPEN ANGLE, D (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07359547 currently recruiting?
Yes, NCT07359547 is actively recruiting participants. Contact the research team at oogziekten.glaucoomstudies@uzleuven.be for enrollment information.
Where is the NCT07359547 trial being conducted?
This trial is being conducted at Leuven, Belgium, Bonn, Germany, Lisbon, Portugal.
Who is sponsoring the NCT07359547 clinical trial?
NCT07359547 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 166 participants.