This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analyzed. Efficacy is measured using functional vision and visual function tests before and after implantation as well as with the system on and system off.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Medical University of Graz
Graz, Austria
Clinique Ophtalmologique du CHU de Nantes
Nantes, France
CHU Nimes, Service Ophtalmologie (France)/ Hopital Gui de Chauliac, CHU Montpelier, (France)
Nîmes, France
Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild
Paris, France
Dept. of Ophthalmology, University of Bonn
Bonn, Germany
Universitäts KlinikumKlinik für Augenheilkunde Freiburg
Freiburg im Breisgau, Germany
Klinik und Poliklinik für Augenheilkunde Hamburg -Eppendorf
Hamburg, Germany
Instituto de Microcirugia Ocular
Barcelona, Spain
Moorfields Eye Hospital
London, United Kingdom
Number of participants with treatment-related adverse events according to ISO14155
All subjects undergo ophthalmological examinations in predefined intervals after implantation. Adverse event are rated to be serious or non-serious according ISO14155
Time frame: up to 36 month
Visual acuity
Measure probable benefit with square wave grating test
Time frame: up to 36 month
Square localization
Measure probable by measuring the error in localizing a white square on black background.
Time frame: up to 36 month
Functional Vision
Measure probable benefit e.g. by Functional Picture Assessment. The number of errors subjects make in detecting objects or persons on standardized pictures is measures. Other test may be developed during the study.
Time frame: up to 36 month
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