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Clinical Trial

Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt

NCT: NCT07359547 · RECRUITING

NCT IDNCT07359547
StatusRECRUITING
Start Date2026-01-01
Completion2028-01

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 XEN®-63 Gel Stent 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 the XEN®-63 Gel Stent? * How do the two devices compare over 24 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 XEN®-63 Gel Stent or the PRESERFLO™ MicroShunt during a single glaucoma surgery. * Attend scheduled follow-up visits over 24 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.

Frequently Asked Questions

What is Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt?

Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt is a clinical trial registered under NCT07359547. Current status: RECRUITING.

What is the status of NCT07359547?

The current status of NCT07359547 (Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt) is: RECRUITING.

When did Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt start?

Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt started on 2026-01-01.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.