PRESERFLO™ MicroShunt XI observational PMCF study
Research type
Research Study
Full title
Post Market Clinical Follow-Up Study to demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in patients with primary open angle glaucoma.
IRAS ID
359047
Contact name
Kin Sheng Lim
Contact email
Sponsor organisation
Santen SAS
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This study focuses on adult primary open angle glaucoma patients who are at increased risk of surgical failure due to scarring, such as those who have previously undergone unsuccessful trabeculectomy or PRESERFLO™ MicroShunt 8.5mm implant procedures. The PRESERFLO™ MicroShunt XI (11mm) implant is designed to drain fluid further back in the eye, into an area with fewer fibroblasts (cells responsible for scar formation). By targeting this area, the risk of scarring and subsequent surgical failure may be reduced. This research is particularly important for patients with a long eyeball or a history of scarring, as it may offer improved and longer-lasting control of eye pressure and help preserve vision. The purpose of this study is to collect safety and performance data on the PRESERFLO™ MicroShunt XI (11mm) 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. The study is a post-market clinical follow-up, aiming to collect safety and performance data on the CE marked PRESERFLO™ MicroShunt XI (11mm) device. Up to 112 participants will be enrolled across 11 centers in Europe. After implantation, participants will be followed for 12 months, including up to 8 follow-up visits. During these visits, the investigator will check participant’s medication use, conduct Intraoccular Pressure measurements, perform various eye examinations and review adverse events.
REC name
London - Dulwich Research Ethics Committee
REC reference
25/LO/0658
Date of REC Opinion
18 Sep 2025
REC opinion
Favourable Opinion