Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversitaire Ziekenhuizen KU Leuven

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.

Eligibility criteria

Qualifiers

>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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • XEN®-63 Gel Stent
  • PRESERFLO™ MicroShunt

Treatment groups

166 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

University Hospital, Bonn

Collaborator

Hospital de Santa Maria, Lisbon

Collaborator