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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• \>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

Locations
Other Locations
Belgium
University Hospitals UZ Leuven
RECRUITING
Leuven
Germany
Universitätsklinikum Bonn
RECRUITING
Bonn
Portugal
ULS Santa Maria
NOT_YET_RECRUITING
Lisbon
Contact Information
Primary
Ingeborg Stalmans, MD, PhD
oogziekten.glaucoomstudies@uzleuven.be
+3216340391
Backup
Thomas Jacobs, MD
thomas.jacobs@uzleuven.be
+16346108
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2028-01
Participants
Target number of participants: 166
Treatments
Experimental: PRESERFLO MicroShunt
The PFMS is a SIBS-polymer microshunt.
Active_comparator: XEN 63 Gelstent
The XEN 63 Gelstent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin).
Sponsors
Collaborators: Hospital de Santa Maria, Lisbon, University Hospital, Bonn
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov