GLAUCOMA 1, OPEN ANGLE, D (Disorder)MINI-BATTLENCT07359547
Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt
A study testing XEN®-63 Gel Stent and PRESERFLO™ MicroShunt in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder), run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- What is being tested?
- XEN®-63 Gel Stent and PRESERFLO™ MicroShunt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jan 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals UZ Leuven
Leuven, Vlaams-brabant, 3000
Ingeborg Stalmans, Prof. Dr., +3216340391, oogziekten.glaucoomstudies@uzleuven.be
Thomas Jacobs, MD, +3216346108, thomas.jacobs@uzleuven.be
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, D-53127
Karl Mercieca, Prof. Dr., +44 7894 230224, Karl.Mercieca@ukbonn.de
Portugal1 site, 1 recruiting
- Not yet recruiting
ULS Santa Maria
Lisbon, Lisbon District, 1649-028
Luis Pinto, Prof. Dr., +351 965 132 279, abegaopinto@gmail.com
About this study
Official 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
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:
Read more
- 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.
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- Being tested
- XEN®-63 Gel Stent, PRESERFLO™ MicroShunt
- Keywords
- Glaucoma, MIBS, Minimally Invasive Bleb-Forming Surgery, Bleb-Forming Devices Without a Plate, Surgery, PRESERFLO, MicroShunt, XEN, Gelstent
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XEN®-63 Gel StentDevice
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™ MicroShuntDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PRESERFLO MicroShunt | Experimental | The PFMS is a SIBS-polymer microshunt. Receives: Device: PRESERFLO™ MicroShunt |
| XEN 63 Gelstent | Active comparator | The XEN 63 Gelstent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). Receives: Device: XEN®-63 Gel Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: 1 year
Secondary outcomes (7)
Number of medications
Number of topical glaucoma medications
Measured: 2 year
adverse events
Measured: 2 years
secundary pressure-lowering surgery
Measured: 2 years
Mean Deviation changes on the visual field
Measured: 2 years
Retinal Nerve Fibre Layer Thickness changes on Optical Coherence Tomography
Measured: 2 years
Endothelial Cell Count
Measured: 2 years
Best Corrected Visual Acuity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLAUCOMA 1, OPEN ANGLE, D (Disorder)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bonn, Hospital de Santa Maria, Lisbon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359547
- Sponsor's protocol ID
- S70640
- Acronym
- MINI-BATTLE
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07359547
- Acronym / sponsor ID
- MINI-BATTLE / S70640
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- Keywords
- Glaucoma, MIBS, Minimally Invasive Bleb-Forming Surgery, Bleb-Forming Devices Without a Plate, Surgery, PRESERFLO, MicroShunt, XEN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University Hospital, Bonn, Hospital de Santa Maria, Lisbon
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRESERFLO MicroShunt | Experimental | Device: PRESERFLO™ MicroShuntThe PFMS is a SIBS-polymer microshunt. |
| XEN 63 Gelstent | Active comparator | Device: XEN®-63 Gel StentThe XEN 63 Gelstent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XEN®-63 Gel StentThe 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. | Device | XEN 63 Gelstent |
| PRESERFLO™ MicroShuntThe 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. | Device | PRESERFLO MicroShunt |
Primary outcome
Intraocular pressure
Time frame: 1 year
7 secondary outcomes
Number of medications
Time frame: 2 year
adverse events
Time frame: 2 years
secundary pressure-lowering surgery
Time frame: 2 years
Mean Deviation changes on the visual field
Time frame: 2 years
Retinal Nerve Fibre Layer Thickness changes on Optical Coherence Tomography
Time frame: 2 years
Endothelial Cell Count
Time frame: 2 years
Best Corrected Visual Acuity
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XEN®-63 Gel Stent and PRESERFLO™ MicroShunt in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder), run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingeborg Stalmans, MD, PhD (+3216340391, oogziekten.glaucoomstudies@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.