Post Market Clinical Follow-Up Study to Demonstrate the Safety and Performance of the PRESERFLO™ MicroShunt XI in Patients With Primary Open Angle Glaucoma
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Male or female, age 18 to 85 years, inclusive
• Patient diagnosed with primary open glaucoma where the IOP is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure ≥18 mmHg and ≤35 mmHg while on glaucoma medications
• Patient willing to comply with study requirements
• Patient who has signed an approved informed consent form
Locations
Other Locations
Austria
AKH Wien
NOT_YET_RECRUITING
Vienna
Belgium
Glaucoma Clinic, UZ Leuven
NOT_YET_RECRUITING
Leuven
Germany
Internationale Innovative Opthalmochirurgie GbR
NOT_YET_RECRUITING
Düsseldorf
Universitätsklinikum Tübingen, Department für Augenheilkunde
NOT_YET_RECRUITING
Tübingen
Italy
Irccs Fondazione G. B. Bietti
NOT_YET_RECRUITING
Rome
Policlinico Universitario Molinette
NOT_YET_RECRUITING
Turin
Netherlands
Universiteitskliniek voor Oogheelkunde Maastricht
NOT_YET_RECRUITING
Maastricht
Portugal
ULS Santa Maria, Lisboa
NOT_YET_RECRUITING
Lisbon
Spain
Hospital Clinico San Carlos
NOT_YET_RECRUITING
San Carlos
United Kingdom
Guy's and St. Thomas' NHS Foundation Trust
RECRUITING
London
Moorfields Eye Hospital NHS Foundation Trust
NOT_YET_RECRUITING
London
Contact Information
Primary
Study Director / Medical Monitor Raymund Angeles
raymund.angeles@santen.com
510-368-9861
Backup
Santen SAS Clinical Operations
bianca.groenendijk@santen.com
Time Frame
Start Date: 2026-03-19
Estimated Completion Date: 2027-09
Participants
Target number of participants: 112
Treatments
Microshunt XI treatment group
MicroShunt XI will be surgically implanted in eyes of patients with primary open angle glaucoma where intra ocular pressure (IOP) remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery.
Related Therapeutic Areas
Sponsors
Leads: Santen SAS