GLAUCOMA 1, OPEN ANGLE, D (Disorder)PMSvTNCT07496957
Preserflo MicroShunt Versus Trabeculectomy
A study testing Preserflo MicroShunt Implantation and Trabeculectomy with MMC in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder), run by Medical University of Bialystok at 1 site in Poland.
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 21 years and older
- Conditions the study is for
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- What is being tested?
- Preserflo MicroShunt Implantation and Trabeculectomy with MMC
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2026to 1 Dec 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ->21 years of age
- An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEXG)
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Bialystok
Bialystok, Polska, 15-089
Joanna Konopinska, +48857468372, joannakonopinska@o2.pl
About this study
Official title: Preserflo MicroShunt Implantation Versus Trabeculectomy in Managing Open-Angle Glaucoma
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 trabeculectomy 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 trabeculectomy? How do these two surgeries compare over 12 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 trabeculectomy or the PRESERFLO™ MicroShunt during a single glaucoma surgery.
Attend scheduled follow-up visits over 12 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
- Preserflo MicroShunt Implantation, Trabeculectomy with MMC
- Keywords
- open angle glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preserflo MicroShunt ImplantationDevice
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.
Trabeculectomy with MMCProcedure or surgery
Trabeculectomy (TE) has been steadily improved over the last decades and remains globally accepted as the therapeutic gold standard, great efforts are being made to develop alternative surgical options. This is mainly due to the high rate of complications after TE, including hypotony with choroidal detachment, a flat anterior chamber, or hyphema, as well as a complex postoperative follow-up
| Study group | Role | What they receive |
|---|---|---|
| Procedure: trabeculectomy | Active comparator | trabeculectomy with mitomycin C Receives: Procedure: Trabeculectomy with MMC |
| PreserFlo Microshunt | Experimental | Preserflo MicroShunt implantation Receives: Device: Preserflo MicroShunt Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Intraocular pressure will be assesed with Goldmann Applanation tonometer at the same time of a day between 8.00-10.00 am.
Measured: 12 months
Secondary outcomes (3)
Number of medications
Measured: 12 months
surgical success
Complete surgical success is defined as achieving an IOP of ≤ 18 mmHg and a reduction of ≥20% from baseline, without the need for additional antiglaucoma medication.
Qualified success was defined as achieving an IOP ≤ 18 mmHg and a reduction of ≥20% from baseline, while concurrently using intraocular pressure-lowering medications (maximum 2).
Measured: 12 months
complications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GLAUCOMA 1, OPEN ANGLE, D (Disorder)Studies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Konopińska, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496957
- Sponsor's protocol ID
- 1776
- Other IDs
- 1776
- Acronym
- PMSvT
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Governatori L, Oliverio L, Mermoud A, Scampoli A, Sarati F, Carradori A, Catalani R, Monaco C, Caporossi T, Rizzo S. PreserFlo MicroShunt versus trabeculectomy: an updated meta-analysis and systematic review. Graefes Arch Clin Exp Ophthalmol. 2025 Apr;263(4):885-899. doi: 10.1007/s00417-024-06649-w. Epub 2024 Oct 12.
PubMed 39394492Nobl M, Grun C, Kassumeh S, Priglinger S, Mackert MJ. One-Year Outcomes of PreserfloTM MicroShunt Implantation versus Trabeculectomy for Pseudoexfoliation Glaucoma. J Clin Med. 2023 Apr 20;12(8):3000. doi: 10.3390/jcm12083000.
PubMed 37109334
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preserflo MicroShunt Implantation Versus Trabeculectomy in Managing Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT07496957
- Acronym / sponsor ID
- PMSvT / 1776
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- Keywords
- open angle glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 27 Mar 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 trabeculectomy 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 trabeculectomy? How do these two surgeries compare over 12 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 trabeculectomy or the PRESERFLO™ MicroShunt during a single glaucoma surgery.
Attend scheduled follow-up visits over 12 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedure: trabeculectomy | Active comparator | Procedure: Trabeculectomy with MMCtrabeculectomy with mitomycin C |
| PreserFlo Microshunt | Experimental | Device: Preserflo MicroShunt ImplantationPreserflo MicroShunt implantation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ->21 years of age
- An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEXG)
- 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 |
|---|---|---|
| Preserflo MicroShunt ImplantationThe 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 |
| Trabeculectomy with MMCTrabeculectomy (TE) has been steadily improved over the last decades and remains globally accepted as the therapeutic gold standard, great efforts are being made to develop alternative surgical options. This is mainly due to the high rate of complications after TE, including hypotony with choroidal detachment, a flat anterior chamber, or hyphema, as well as a complex postoperative follow-up | Procedure or surgery | Procedure: trabeculectomy |
Primary outcome
Intraocular pressure
Time frame: 12 months
Intraocular pressure will be assesed with Goldmann Applanation tonometer at the same time of a day between 8.00-10.00 am.
3 secondary outcomes
Number of medications
Time frame: 12 months
surgical success
Time frame: 12 months
complications
Time frame: 12 months
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 27 Mar 2026.
- Background: PubMed 39394492Governatori L, Oliverio L, Mermoud A, Scampoli A, Sarati F, Carradori A, Catalani R, Monaco C, Caporossi T, Rizzo S. PreserFlo MicroShunt versus trabeculectomy: an updated meta-analysis and systematic review. Graefes Arch Clin Exp Ophthalmol. 2025 Apr;263(4):885-899. doi: 10.1007/s00417-024-06649-w. Epub 2024 Oct 12.
- Background: PubMed 37109334Nobl M, Grun C, Kassumeh S, Priglinger S, Mackert MJ. One-Year Outcomes of PreserfloTM MicroShunt Implantation versus Trabeculectomy for Pseudoexfoliation Glaucoma. J Clin Med. 2023 Apr 20;12(8):3000. doi: 10.3390/jcm12083000.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preserflo MicroShunt Implantation and Trabeculectomy with MMC in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder), run by Medical University of Bialystok at 1 site in Poland.
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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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 Joanna Konopinska (+48857468372, joanna.konopinska@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07496957, which also lists 2 linked publications.
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 27 Mar 2026.