Health TrialsbyHealthPanel

Preserflo MicroShunt Versus Trabeculectomy

ConditionGLAUCOMA 1, OPEN ANGLE, D (Disorder)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMedical University of Bialystok

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Procedure: trabeculectomyActive comparator 1 intervention
Group B: PreserFlo MicroshuntExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Number of medications

Time frame
12 months
2

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
3

complications

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Bialystok

Lead sponsor

Source ClinicalTrials.gov
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