An interventional study of Retinal Implant System (IRIS) in Retinitis Pigmentosa, Cone-Rod Dystrophy and Choroideremia, sponsored by Intelligent Medical Implants GmbH. Status unknown. Open to participants aged 30 Years to 79 Years. Per ClinicalTrials.gov, last updated 2010-03-03.
Sponsored by Intelligent Medical Implants GmbH · Not applicable, Interventional, and Treatment
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.
250 studies on the registry are indexed under Retinitis; 28 are open to participants now.
This study's planned enrollment of 20 is below the median of 31 across 158 interventional studies indexed under Retinitis.
Browse Retinitis studies →This is the only study on the registry with Intelligent Medical Implants GmbH as lead sponsor.
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Exclusion Criteria
AIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retina
Also known as: IRIS
Investigate whether blind subjects that fulfill the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.
Time frame: 18 months
Secondary goals of this study phase are: Further evaluation of stimulation parameters, Light localization with use of camera, Safety verification of stimulation parameters
Time frame: 18 months
No study locations are listed for this record.
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