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.
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.
Study Type
OBSERVATIONAL
Enrollment
112
The PRESERFLO™ MicroShunt XI is an implantable glaucoma drainage device
AKH Wien
Vienna, Austria
Glaucoma Clinic, UZ Leuven
Leuven, Belgium
Internationale Innovative Opthalmochirurgie GbR
Düsseldorf, Germany
Primary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure
This is a primary performance outcome to determine the proportion of eyes with ≥20% change and 6 mmHg to \<21 mmHg intraocular pressure from screening to 12 months
Time frame: Screening to 12 months
Secondary Performance Outcome to determine the change in the proportion of eyes with change in intraocular pressure
This is a secondary performance outcome to determine the proportion of eyes with ≥20% change and 6 mmHg to \<18 mmHg intraocular pressure at 12 months
Time frame: At 12 months
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Universitätsklinikum Tübingen, Department für Augenheilkunde
Tübingen, Germany
Irccs Fondazione G. B. Bietti
Rome, Italy
Policlinico Universitario Molinette
Turin, Italy
Universiteitskliniek voor Oogheelkunde Maastricht
Maastricht, Netherlands
ULS Santa Maria, Lisboa
Lisbon, Portugal
Hospital Clinico San Carlos
San Carlos, Spain
Guy's and St. Thomas' NHS Foundation Trust
London, United Kingdom
...and 1 more locations