NCT07359547Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 166 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Glaucoma
- NCT number
- NCT07359547
What you commit to
- Study type: Interventional
- Planned participants: 166
- From 1 Jan 2026 to the primary completion date, 31 Jan 2027
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Current corticosteroid use (ocular or oral)
- Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date
Other
- 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
- Presence of intraocular silicone oil
- No light perception vision
- Conjunctival pathologies (e.g., pterygium)
- Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
- Vitreous present in the anterior chamber
- Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits
Who the study is looking for
- \>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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Universitätsklinikum Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| ULS Santa Maria Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.