RecruitingNot ApplicableNCT07359547

Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt

Minimally Invasive Bleb-Forming Surgical Approaches for Treating Primary Open-Angle Glaucoma: A Randomized Controlled Trial Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

166 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study compares two small eye implants — the XEN-63 gel stent and the PRESERFLO MicroShunt — to see which is more effective and safer for treating glaucoma that is not controlled by eye drops. **You may be eligible if...** - You are over 40 years old - You have primary open-angle glaucoma, normal tension glaucoma, pigmentary glaucoma, or pseudoexfoliative glaucoma - Your eye pressure is between 14 and 28 mmHg despite using maximum tolerated eye drop medications - Your corneal cell count meets the minimum threshold - Your vision loss meets specific criteria (mean deviation of -3 or worse) **You may NOT be eligible if...** - You have closed-angle glaucoma or other secondary types of glaucoma - You have had previous glaucoma surgery, certain laser treatments in the past 3 months, or eye surgery involving the conjunctiva in the past 3–6 months - You have no useful vision (no light perception) - You currently use corticosteroid eye drops or oral steroids - You have active eye inflammation, infection, or abnormal blood vessel growth in the eye - You have an artificial lens placed in front of the iris Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEXEN®-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.

DEVICEPRESERFLO™ 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.


Locations(3)

University Hospitals UZ Leuven

Leuven, Vlaams-brabant, Belgium

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

ULS Santa Maria

Lisbon, Lisbon District, Portugal

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NCT07359547


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