Preserflo MicroShunt Versus Trabeculectomy

NCT07496957 | Recruiting

• 1 other identifier: 1776
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

GLAUCOMA 1, OPEN ANGLE, D (Disorder)

Keywords

open angle glaucoma

Outcome Measures

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.

  12 months

Secondary Outcomes (3)

• Number of medications

  12 months

• surgical success

  12 months

• complications

  12 months

Study Arms (2)

Procedure: trabeculectomy

ACTIVE COMPARATOR

trabeculectomy with mitomycin C

Procedure: Trabeculectomy with MMC

PreserFlo Microshunt

EXPERIMENTAL

Preserflo MicroShunt implantation

Device: Preserflo MicroShunt Implantation

Interventions

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.

PreserFlo Microshunt

Trabeculectomy with MMC PROCEDURE

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

Procedure: trabeculectomy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Medical University of Bialystok

Bialystok, Polska, 15-089, Poland

RECRUITING

Related Publications (2)

• Governatori L, Oliverio L, Mermoud A, Scampoli A, Sarati F, Carradori A, Catalani R, Monaco C, Caporossi T, Rizzo S. PreserFlo MicroShunt versus trabeculectomy: an updated meta-analysis and systematic review. Graefes Arch Clin Exp Ophthalmol. 2025 Apr;263(4):885-899. doi: 10.1007/s00417-024-06649-w. Epub 2024 Oct 12.

  PMID: 39394492 BACKGROUND

• Nobl M, Grun C, Kassumeh S, Priglinger S, Mackert MJ. One-Year Outcomes of PreserfloTM MicroShunt Implantation versus Trabeculectomy for Pseudoexfoliation Glaucoma. J Clin Med. 2023 Apr 20;12(8):3000. doi: 10.3390/jcm12083000.

  PMID: 37109334 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Joanna Konopinska

CONTACT

+48857468372; joanna.konopinska@umb.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffesor

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

PL (1)