Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt
Recruiting · NCT07359547 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitaire Ziekenhuizen KU Leuven
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
3 locations listed.
- ULS Santa Maria - Lisbon, Lisbon District, Portugal
- Universitätsklinikum Bonn - Bonn, North Rhine-Westphalia, Germany
- University Hospitals UZ Leuven - Leuven, Vlaams-brabant, Belgium