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M. Velikay–Parel, A. Langmann, G. Langmann, G. Richard, T. Zehnder, R. Hornig; Clinical Test Procedures for Intraocular Visual Prostheses . Invest. Ophthalmol. Vis. Sci. 2005;46(13):5271.
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Purpose: To determine adequate tests and exams for a clinical trail in chronically functional visual epiretinal prostheses. Methods: The Retina Implant is a learning visual epiretinal prostheses. Patients from no light perception to light perception with certified retinitis pigmentosa and no other ocular comorbitity except cataract operations will be recruited. A general understanding of the concept of the clinical trial has to be provided. Implantation of the device will be carried out under general anesthesia. The first activation of the implant will be carried out after the first postoperative week in the manner of gradual stimulation according the protocol. Since visual perception at this point of time will be very low, several tests concerning the low vision area have to be created such as electrical test pattern(without camera), optical test pattern (with camera), mobility test (with camera), as well as adopted standardised life quality tests to the evaluate the outcome and the progress in vision. Results: Untreated RP–patients with low vision are tested. Stability, reliability of test performance are evaluated. These tests will be necessary to tune and train patients with a learning retinal prostheses. Methods to evaluate the changes in the visual cortex will be included. Conclusions: These tests are capable to show the efficacy of our developed visual prostheses and monitor the progress. Moreover we are able to generate a quantitative feedback for the tuning process.
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