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NCT Number: NCT07496957

Preserflo MicroShunt Versus Trabeculectomy

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.

Recruiting

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Bialystok

Bialystok, Polska, 15-089, Poland

Location status: Recruiting

Location contact

Joanna Konopinska

CONTACT

[email protected]

+48857468372

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

->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

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

Preserflo MicroShunt Implantation

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.

Trabeculectomy with MMC

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of medications

    Time frame: 12 months

  2. surgical success

    Time frame: 12 months

    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).

  3. complications

    Time frame: 12 months

Study contacts

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

Joanna Konopinska

CONTACT

[email protected]

+48857468372

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

Preserflo MicroShunt Implantation Versus Trabeculectomy in Managing Open-Angle Glaucoma

Acronym: PMSvT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Mar 27, 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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