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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
166
The XEN®-63 Gel Stent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.
The PRESERFLO™ MicroShunt is a SIBS-polymer microshunt. This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.
University Hospitals UZ Leuven
Leuven, Vlaams-brabant, Belgium
RECRUITINGUniversitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
RECRUITINGULS Santa Maria
Lisbon, Lisbon District, Portugal
NOT_YET_RECRUITINGIntraocular pressure
Time frame: 1 year
Number of medications
Number of topical glaucoma medications
Time frame: 2 year
adverse events
Time frame: 2 years
secundary pressure-lowering surgery
Time frame: 2 years
Mean Deviation changes on the visual field
Time frame: 2 years
Retinal Nerve Fibre Layer Thickness changes on Optical Coherence Tomography
Time frame: 2 years
Endothelial Cell Count
Time frame: 2 years
Best Corrected Visual Acuity
Time frame: 2 years
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