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Recruiting NCT07359547

Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt

No phase Interventional GLAUCOMA 1, OPEN ANGLE, D (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XEN®-63 Gel Stent, PRESERFLO™ MicroShunt.
Who it may be relevant to
Registry conditions: GLAUCOMA 1, OPEN ANGLE, D (Disorder). Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Germany, Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Intraocular pressure [Time frame: 1 year]
Secondary outcome measures (7)
  • Number of medications [Time frame: 2 year]
  • adverse events [Time frame: 2 years]
  • secundary pressure-lowering surgery [Time frame: 2 years]
  • Mean Deviation changes on the visual field [Time frame: 2 years]
  • Retinal Nerve Fibre Layer Thickness changes on Optical Coherence Tomography [Time frame: 2 years]
  • Endothelial Cell Count [Time frame: 2 years]
  • Best Corrected Visual Acuity [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • University Hospitals UZ Leuven — Leuven
Germany · 1 center
  • Universitätsklinikum Bonn — Bonn
Portugal · 1 center
  • ULS Santa Maria — Lisbon

Identifiers

NCT: NCT07359547 · S70640

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗