RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - \>40 years of age - An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEX) - Inadequately controlled on maximum tolerated medical therapy. - Mean Deviation (MD) \</= -3 - Intraocular pressure of 14-28 mmHg - Endothelial Cell Count ≥1000 cells/mm2 Who Should NOT Join This Trial: - An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX) - Lens status: Aphakic patients or Anterior chamber intraocular lens - Previous procedures: Glaucoma shunt/valve/ surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months. - Presence of intraocular silicone oil - No light perception vision - Current corticosteroid use (ocular or oral) - Conjunctival pathologies (e.g., pterygium) - Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) - Vitreous present in the anterior chamber - Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date - Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * \>40 years of age * An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEX) * Inadequately controlled on maximum tolerated medical therapy. * Mean Deviation (MD) \</= -3 * Intraocular pressure of 14-28 mmHg * Endothelial Cell Count ≥1000 cells/mm2 Exclusion Criteria: * An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX) * Lens status: Aphakic patients or Anterior chamber intraocular lens * Previous procedures: Glaucoma shunt/valve/ surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months. * Presence of intraocular silicone oil * No light perception vision * Current corticosteroid use (ocular or oral) * Conjunctival pathologies (e.g., pterygium) * Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) * Vitreous present in the anterior chamber * Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date * Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits

Treatments Being Tested

DEVICE

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.

DEVICE

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.

Locations (3)

University Hospitals UZ Leuven

Leuven, Vlaams-brabant, Belgium

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

ULS Santa Maria

Lisbon, Lisbon District, Portugal