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PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

NCT07235592 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2026-01-16

No results posted yet for this study

Summary

The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI in patients diagnosed with primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥18 mmHg and ≤35 mmHg and/or where glaucoma progression warrants surgery.

Conditions

  • Primary Open Angle Glaucoma

Interventions

DEVICE

Microshunt XI

The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device

Sponsors & Collaborators

  • Santen SAS

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-04-30
Completion
2027-04-30

Countries

  • Austria
  • Belgium
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07235592 on ClinicalTrials.gov