Actively Recruiting
Preserflo MicroShunt Versus Trabeculectomy
Led by Medical University of Bialystok · Updated on 2026-03-27
100
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preserflo MicroShunt Versus Trabeculectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 21 years of age
- Diagnosed with primary open angle glaucoma, normal tension glaucoma, pigment dispersion glaucoma, or pseudoexfoliative glaucoma
- Glaucoma not controlled adequately with maximum tolerated medical therapy
- Mean deviation (MD) of visual field test less than or equal to -3
- Intraocular pressure between 14 and 28 mmHg
- Endothelial cell count of 1000 cells/mm2 or higher
You will not qualify if you...
- Diagnosed with closed-angle glaucoma or secondary open-angle glaucoma other than pigment dispersion or pseudoexfoliative glaucoma
- Aphakic patients or those with anterior chamber intraocular lens
- Previous glaucoma shunt, valve, surgery, or cyclodestructive procedure
- Selective laser trabeculoplasty within the past 3 months
- Incisional eye surgery involving the conjunctiva within the past 3 months
- Clear corneal cataract or trabecular meshwork surgery within the past 6 months
- Presence of intraocular silicone oil
- No light perception vision
- Current use of corticosteroids (ocular or oral)
- Conjunctival diseases such as pterygium
- Active eye inflammation like blepharitis, conjunctivitis, keratitis, or uveitis
- Vitreous present in the anterior chamber
- Active iris neovascularization or iris neovascularization within 6 months before surgery
- Unwillingness or inability to consent, accept randomization, or participate in scheduled visits
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Bialystok
Bialystok, Polska, Poland, 15-089
Actively Recruiting
Research Team
J
Joanna Konopinska
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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