This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.
This study is being conducted to monitor the use of Argus II in a larger population than available within pre-market approval studies. Safety data will be monitored to ensure continued acceptability of risks to study participants, and an attempt will be made to include all eligible and willing participants implanted with Argus II. Measures of visual function that may contribute to device improvements will also be gathered and evaluated.
Study Type
OBSERVATIONAL
Enrollment
52
Augenklinik des Staedtischen Klinikums
Karlsruhe, Baden-Wurttemberg, Germany
Klinikum rechts der Isar - Technical University
Munich, Bavaria, Germany
Center for Ophthalmology - University of Koln
Cologne, North Rhine-Westphalia, Germany
adverse events
nature and rate of adverse events
Time frame: up to 3 years from time of implantation
visual function
Square localization, direction of motion, grating visual acuity
Time frame: up to 3 years from time of implantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Knappschaftsklinikum Saar, Department of Ophthalmology
Sulzbach, Saarland, Germany
University Medical Center Schleswig-Holstein, Department of Ophthalmology
Lübeck, Schleswig-Holstein, Germany
RWTH University Eye Clinic
Aachen, Germany
University Hospital Hamburg-Eppendorf, Klinik u. Poliklinik fur Augenheilkunde
Hamburg, Germany
Universitätsklinikum Leipzig AöR, Klinik und Poliklinik für Augenheilkunde
Leipzig, Germany
University of Pisa Eye Surgery Department
Pisa, Tuscany, Italy
ULSS 15 Alta Padovana Hospital
Camposampiero, Veneto, Italy