XEN®-63 Gel Stent: 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.
PRESERFLO™ MicroShunt: 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.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospitals UZ Leuven | Leuven | Vlaams-brabant | Recruiting |
| Universitätsklinikum Bonn | Bonn | North Rhine-Westphalia | Recruiting |
| ULS Santa Maria | Lisbon | Lisbon District | Not Yet Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07359547 on ClinicalTrials.gov ↗ ← All trials in Germany