An interventional study of Preserflo MicroShunt Implantation and Trabeculectomy with MMC in GLAUCOMA 1, OPEN ANGLE, D (Disorder), sponsored by Medical University of Bialystok. Recruiting at 1 site in Poland. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Medical University of Bialystok · Not applicable, Interventional, and Treatment
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.
924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.
Browse Glaucoma, Open-Angle studies →Medical University of Bialystok is the lead sponsor of 72 studies on the registry; 18 are open to participants now.
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->21 years of age
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
trabeculectomy with mitomycin C
Procedure: Trabeculectomy with MMC
Preserflo MicroShunt implantation
Device: Preserflo MicroShunt Implantation
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 (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
Intraocular pressure
Intraocular pressure will be assesed with Goldmann Applanation tonometer at the same time of a day between 8.00-10.00 am.
Time frame: 12 months
Number of medications
Time frame: 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).
Time frame: 12 months
complications
Time frame: 12 months
Plan to share: Undecided
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Medical University of Bialystok