XEN‑63 Gel Stent versus PRESERFLO MicroShunt for lowering eye pressure in open‑angle glaucoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with open‑angle glaucoma who need surgical lowering of intraocular pressure are randomly assigned 1:1 to receive either the XEN‑63 Gel Stent or the PRESERFLO MicroShunt during a single glaucoma operation. The primary goal is to show non‑inferior IOP reduction at 12 months, with additional follow‑up to 24 months to compare medication use, need for further glaucoma procedures, complications, and preservation of vision and ocular structures. Follow‑up visits include eye‑pressure measurements and clinical exams at scheduled intervals. The trial is conducted at major academic centers in Belgium, Germany, and Portugal.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospitals UZ Leuven
  Leuven, Vlaams-brabant, Belgium Recruiting
• Universitätsklinikum Bonn
  Bonn, North Rhine-Westphalia, Germany Recruiting
• ULS Santa Maria
  Lisbon, Lisbon District, Portugal Not yet recruiting

Study contacts

• Study coordinator: Ingeborg Stalmans, MD, PhD
• Email: oogziekten.glaucoomstudies@uzleuven.be
• Phone: +3216340391

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing PRESERFLO MicroShunt and trabeculectomy to lower eye pressure in open-angle glaucoma.

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• G01 Eye Drops for Glaucomatous Optic Neuropathy

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• Lifestyle changes plus nightly CPAP for glaucoma in people with sleep apnea

  This test checks whether adding a low-calorie diet and regular walking to nightly CPAP lowers eye pressure in people with high‑pressure open‑angle glaucoma who also have obstructive sleep apnea and obesity.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.