Comparing Two Eye Surgeries for Lowering Pressure in Open-Angle Glaucoma
Compares the Preserflo MicroShunt with trabeculectomy in adults with open-angle glaucoma.
Plain-language title generated from the registry record
Registry title: Preserflo MicroShunt Versus Trabeculectomy
Key facts
- Where
- Bialystok, PolandSee the site
Where in Poland
- Medical University of BialystokBialystok, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Bialystok
- Trial code
- NCT07496957
- Record updated
- 27 March 2026
- Original description
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.Read full original descriptionShow less
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:
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.
Inclusion: ->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: 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; Current corticosteroid use (ocular or oral); Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date; 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; Presence of intraocular silicone oil; No light perception vision; Conjunctival pathologies (e.g., pterygium); Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis); Vitreous present in the anterior chamber; Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits.