Actively Recruiting
Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-04-29
166
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
U
University Hospital, Bonn
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 40 years of age
- Diagnosed with primary open-angle glaucoma, normal tension glaucoma, pigment dispersion glaucoma, or pseudoexfoliative glaucoma
- Glaucoma not adequately controlled with maximum tolerated medical therapy
- Mean deviation in visual field test of -3 or worse
- Intraocular pressure between 14 and 28 mmHg
- Endothelial cell count of at least 1000 cells/mm2
You will not qualify if you...
- Diagnosed with closed-angle glaucoma or secondary open-angle glaucoma other than pigment dispersion or pseudoexfoliative glaucoma
- Aphakic or have an anterior chamber intraocular lens
- Previous glaucoma shunt, valve or surgery, or cyclodestructive procedure
- Had selective laser trabeculoplasty or conjunctival eye surgery within the past 3 months
- Had clear corneal cataract or trabecular meshwork surgery within the past 6 months
- Presence of intraocular silicone oil
- No light perception vision
- Current use of ocular or oral corticosteroids
- Conjunctival diseases such as pterygium
- Active eye inflammation like blepharitis, conjunctivitis, keratitis, or uveitis
- Vitreous present in the front chamber of the eye
- Active iris neovascularization or iris neovascularization within 6 months before surgery
- Unable or unwilling to give consent, accept randomization, or attend scheduled visits
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University Hospitals UZ Leuven
Leuven, Vlaams-brabant, Belgium, 3000
Actively Recruiting
2
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany, D-53127
Actively Recruiting
3
ULS Santa Maria
Lisbon, Lisbon District, Portugal, 1649-028
Not Yet Recruiting
Research Team
I
Ingeborg Stalmans, MD, PhD
CONTACT
T
Thomas Jacobs, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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