Santen SAS has announced a new observational post-market clinical follow-up (PMCF) study to evaluate the performance and safety of the PRESERFLO™ MicroShunt XI for individuals diagnosed with primary open angle glaucoma. The study, listed on ClinicalTrials.gov, is currently not yet recruiting and will proceed without a control group. It aims to provide comprehensive data on the device’s real-world applications for glaucoma management.
The MicroShunt XI is a novel medical device designed to alleviate intraocular pressure in glaucoma patients by facilitating controlled drainage of ocular fluid. Regulatory professionals, clinical practitioners, and compliance teams may wish to monitor this trial for insights into its effectiveness and safety profile.
What changed?
This new observational study marks an important step in expanding the clinical evidence for the PRESERFLO™ MicroShunt XI. With plans to enroll primary open angle glaucoma patients, it is expected to assess device performance under real-world conditions, enabling regulators and clinicians to better understand its usability and outcomes. The announcement, made on November 19, 2025, confirms that recruitment has not yet started.
Why is this study important?
Primary open angle glaucoma is a leading cause of irreversible blindness worldwide. Current treatments often involve medications or surgical interventions to control intraocular pressure, a critical factor in slowing the disease’s progression. The PRESERFLO™ MicroShunt XI offers a minimally invasive alternative that could improve patients’ quality of life. Observational PMCF studies like this one play a key role in supporting regulatory compliance by gathering post-market safety and performance data on medical devices per MDR requirements.
Filling data gaps in device performance
Unlike controlled trials, this study focuses on real-world outcomes, potentially uncovering variables not evident during pre-market evaluations. This evidence could guide further optimizations for the MicroShunt and inform future regulatory submissions or updates to clinical guidelines.
How is the study designed?
The study is listed as an observational PMCF trial without a control group. Santen SAS, as the sponsor, will oversee data collection and analysis. Key features of the study include:
- Population: Individuals diagnosed with primary open angle glaucoma.
- Objective: Evaluate the safety and efficacy of the MicroShunt XI in a real-world clinical setting.
- Design: Non-comparative observational framework to collect post-market data.
Compliance with MDR Annex XIV guidelines ensures that findings from this study will have relevance for ongoing device monitoring obligations.
FAQ: Common questions about the study
- What is the PMCF study’s expected duration?
The announcement does not specify the expected duration, but PMCF studies typically follow patients for at least six months to a few years.
- Who is eligible to participate?
Only individuals diagnosed with primary open angle glaucoma are eligible. Recruitment details will be confirmed once the study begins.
- What data will be collected?
The study will focus on device performance, safety outcomes, and potential complications arising during real-world use.
- How can stakeholders monitor updates?
Updates will likely be shared through ClinicalTrials.gov and other regulatory or professional channels.
Conclusion
The PRESERFLO™ MicroShunt XI observational study demonstrates Santen SAS’s ongoing commitment to aligning device performance monitoring with regulatory standards. For clinicians and regulatory stakeholders, the forthcoming results could provide meaningful insights into the device’s practical applications in managing glaucoma. Interested parties should stay informed on this trial as recruitment begins.
Disclaimer
This content is intended for professionals and provides a factual summary of a clinical trial announcement. It is not legal or clinical advice. Please consult the official study page or regulators for authoritative guidance.
Full Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07235592?term=medical+device