Comparing PRESERFLO MicroShunt and trabeculectomy to lower eye pressure in open-angle glaucoma.
Preserflo MicroShunt Implantation Versus Trabeculectomy in Managing Open-Angle Glaucoma
This trial will test whether the PRESERFLO MicroShunt works as well as trabeculectomy to lower eye pressure in adults with open-angle glaucoma who need surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Medical University of Bialystok Academic / other |
| Locations | 1 site (Bialystok, Polska) |
| Trial ID | NCT07496957 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 with primary open-angle, normal-tension, pigment dispersion, or pseudoexfoliative glaucoma inadequately controlled on medications, with IOP 14–28 mmHg, MD ≤ -3, and endothelial cell count ≥1000 who are planning glaucoma surgery.
Not a fit: Patients with closed-angle glaucoma, secondary open-angle glaucomas other than pigment dispersion or pseudoexfoliation, prior conjunctival or glaucoma-shunt surgery, aphakia or anterior chamber IOL, intraocular silicone oil, no light perception, or current corticosteroid use are unlikely to be eligible or to benefit from this comparison.
Why it matters
Potential benefit: If successful, the MicroShunt could provide similar long-term eye-pressure control with a less invasive procedure and potentially fewer complications or faster recovery than trabeculectomy.
How similar studies have performed: Previous observational studies and some randomized trials suggest the PRESERFLO MicroShunt can lower IOP and reduce medication use, but long-term head-to-head data versus trabeculectomy remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bialystok, Polska
- Medical University of Bialystok — Bialystok, Polska, Poland (Recruiting)
Study contacts
- Study coordinator: Joanna Konopinska
- Email: joanna.konopinska@umb.edu.pl
- Phone: +48857468372
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.