Clinical Studies
The first epiretinal implant, the ARGUS device, included a silicon platinum array with 16 electrodes. The Phase I clinical trial of ARGUS began in 2002 by implanting six patients with the device. All patients reported gaining a perception of light and discrete phosphenes, with the visual function of some patients improving significantly over time. Future versions of the ARGUS device are being developed with increasingly dense electrode arrays, allowing for improved spatial resolution. The most recent ARGUS II device contains 60 electrodes, and a 200 electrode device is under development. The ARGUS II device received marketing approval in February 2011 (CE Mark demonstrating safety and performance), and it is available in Germany, France, Italy, and UK. Interim results on 30 patients long term trials were published in Ophthalmology in 2012. Argus II received approval from the US FDA on April 14th 2013 FDA Approval. Another epiretinal device, the Learning Retinal Implant, has been developed by IIP technologies GmbH, and has begun to be evaluated in clinical trials. A third epiretinal device, EPI-RET, has been developed and progressed to clinical testing in six patients. The EPI-RET device contains 25 electrodes and requires the crystalline lens to be replaced with a receiver chip. All subjects have demonstrated the ability to discriminate between different spatial and temporal patterns of stimulation.
Read more about this topic: Retinal Implant, Types of Retinal Implants, Epiretinal Implants
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