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NCT Number: NCT07359547

Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt

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.

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Key information

Conditions

GLAUCOMA 1, OPEN ANGLE, D (Disorder) Eye Diseases Glaucoma Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals UZ Leuven, Leuven, Vlaams-brabant, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XEN®-63 Gel Stent

Device

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.

PRESERFLO™ MicroShunt

Device

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 outcomes

  1. Intraocular pressure

    Time frame: 1 year

Secondary outcomes

  1. Number of medications

    Time frame: 2 year

    Number of topical glaucoma medications

  2. adverse events

    Time frame: 2 years

  3. secundary pressure-lowering surgery

    Time frame: 2 years

  4. Mean Deviation changes on the visual field

    Time frame: 2 years

  5. Retinal Nerve Fibre Layer Thickness changes on Optical Coherence Tomography

    Time frame: 2 years

  6. Endothelial Cell Count

    Time frame: 2 years

  7. Best Corrected Visual Acuity

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ingeborg Stalmans, MD, PhD

CONTACT

[email protected]

+3216340391

Thomas Jacobs, MD

CONTACT

[email protected]

+16346108

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Hospital de Santa Maria, Lisbon
  • University Hospital, Bonn

Registry information

Official study 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

Acronym: MINI-BATTLE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 22, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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