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Minimally Invasive Bleb-Forming Surgical Approaches for Treating Primary Open-Angle Glaucoma: A Randomized Controlled Trial Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt
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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
University Hospitals UZ Leuven
Leuven, Vlaams-brabant, Belgium
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
ULS Santa Maria
Lisbon, Lisbon District, Portugal
Start Date
January 1, 2026
Primary Completion Date
January 1, 2027
Completion Date
January 1, 2028
Last Updated
January 22, 2026
166
ESTIMATED participants
XEN®-63 Gel Stent
DEVICE
PRESERFLO™ MicroShunt
DEVICE
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
NCT06689696
NCT01612416
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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