Comparing PRESERFLO MicroShunt and trabeculectomy to lower eye pressure in open-angle glaucoma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with open-angle glaucoma who require surgical lowering of intraocular pressure are randomly assigned 1:1 to receive either the PRESERFLO MicroShunt implant or a trabeculectomy with mitomycin C during a single operation. Outcomes measured over 12 months include intraocular pressure reduction at 12 months, need for glaucoma medications, additional glaucoma procedures, complications, and visual and ocular-structure preservation. Participants attend scheduled follow-up visits for eye-pressure measurements, vision testing, and safety monitoring. The trial enrolls patients with primary open-angle, normal-tension, pigment dispersion, or pseudoexfoliative glaucoma who remain uncontrolled on maximal tolerated medical therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of Bialystok
  Bialystok, Polska, Poland Recruiting

Study contacts

• Study coordinator: Joanna Konopinska
• Email: joanna.konopinska@umb.edu.pl
• Phone: +48857468372

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.