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Clinical Trial

Preserflo MicroShunt Versus Trabeculectomy

NCT: NCT07496957 · RECRUITING

NCT IDNCT07496957
StatusRECRUITING
Start Date2026-03-01
Completion2028-12-01

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 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.

Frequently Asked Questions

What is Preserflo MicroShunt Versus Trabeculectomy?

Preserflo MicroShunt Versus Trabeculectomy is a clinical trial registered under NCT07496957. Current status: RECRUITING.

What is the status of NCT07496957?

The current status of NCT07496957 (Preserflo MicroShunt Versus Trabeculectomy) is: RECRUITING.

When did Preserflo MicroShunt Versus Trabeculectomy start?

Preserflo MicroShunt Versus Trabeculectomy started on 2026-03-01.

Official Source

View on ClinicalTrials.gov →

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