Preserflo MicroShunt Versus Trabeculectomy (PMSvT)

Medical University of Bialystok

Status: Enrolling

Conditions: GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Treatments: Procedure: Trabeculectomy with MMC; Device: Preserflo MicroShunt Implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT07496957

1776 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Procedure: trabeculectomy

Active Comparator group

Description:

trabeculectomy with mitomycin C

Treatment:

Procedure: Trabeculectomy with MMC

PreserFlo Microshunt

Experimental group

Description:

Preserflo MicroShunt implantation

Treatment:

Device: Preserflo MicroShunt Implantation