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R. Hornig, M. Velikay–Parel, M. Feucht, T. Zehnder, G. Richard; Early Clinical Experience With A Chronic Retinal Implant System For Artificial Vision . Invest. Ophthalmol. Vis. Sci. 2006;47(13):3216.
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To evaluate performance of an investigational Retinal Implant System based on neural responses from electrical stimulation of the retina in RP patients having severe vision loss.
RP patients will undergo surgical placement of the Retinal Implant System (IIP Technologies GmbH, Bonn Germany). Patients will be subjected to electrical stimulation of the retina based on system response to input from defined patterns (horizontal bar, vertical bar, cross). The system will be tuned and each patient will be trained for optimal pattern recognition. The patients will undergo multiple stimulation sessions. Patients will be closely monitored to assess ophthalmologic changes and continued device function.
A clinical trial protocol was developed and approved by the governing Ethics Committee. Patients gave written informed consent for trial participation and underwent screening procedures and surgical preparation to receive the implant. Performance assessments are forthcoming.
Results from this trial will demonstrate the feasibility of a chronic implant system to electrically stimulate the retina for eliciting perceptions resulting from defined input signals. The experience in system tuning and patient training will provide information for developing and optimizing methods for future assessment of retinal implant systems.
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