Retinitis Pigmentosa Clinical Trial
Official title:
Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System
Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.
The Retinal Implant System consists of three main components, the Retinal Stimulator, which
is the component actually implanted into the eye, the visual interface, and the Pocket
Processor The Retinal Stimulator will be implanted into the eye of a blind subject during a
surgical operation. However, the external components are activated only during the test
sessions under the control of the investigator team. In a first step of the investigation a
software controlled system on a PC which is connected to the Pocket Processor via Ethernet
interface, will generate the defined stimulation patterns (bars, crosses, cubes). During the
test session, the blind subject is exposed to a series of these stimulation patterns and he
/ she has to describe the visual perceptions. Based on his descriptions and in an
interactive way, the stimulation signal is subsequently be modulated by changing parameters
like amplitude, duration of impulse, polarity, number of repetitions or pulse frequency on
the PC.
In a second step the visual interface is equipped with a camera which presents realtime
images to the subject. Data obtained from the investigation with computer generated patterns
in the first step are used in the second step to improve the fitting software for the use in
the camera supported system.
Finally the system should enable the subject to recognize simple images supported from the
camera.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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