NCT07235592

PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group

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: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 112 (estimated)
• Sponsor: Santen SAS · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicentric, single arm post market clinical follow-up study to collect safety and performance data on the CE Marked PRESERFLO™ MicroShunt XI device in patients with primary open angle glaucoma. The PRESERFLO™MicroShunt XI employs a tube to create a conduit for the flow of aqueous humor from the anterior chamber of the eye to a bleb formed under the conjunctiva and Tenon's capsule; the front/ proximal end of the tube extends into the anterior chamber while the back/ distal end terminates in the bleb. The PRESERFLO™MicroShunt XI reduces IOP by physically shunting aqueous humor from the high pressure anterior chamber to the lower pressure bleb. The intended users of the PRESERFLO™ MicroShunt XI are ophthalmologists/ophthalmic surgeons specialized in the treatment of glaucoma (including surgeons specialized in anterior segment and cataract surgery) who have been trained to use the device. No biospecimens are collected in this study and no control group.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	Microshunt XI	The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2025-11-19
• Last updated: 2026-01-16

Locations

11 sites across 8 countries: Austria, Belgium, Germany, Italy, Netherlands, Portugal, Spain, United Kingdom