Human Clinical Trials

In the year 2000, we received approval from the United States Food and Drug Administration (FDA; www.fda.gov) to conduct human trials. Our proposal, entitled “Analysis of Thresholds and Perceptions Following Electrical Stimulation of Human Retina with a Microfabricated Array as a Prelude to Developing an Implantable Prosthesis” is designed to determine if volunteers who have been legally blind for decades with retinitis pigmentosa can be made to see images in response to electrical stimulation of the retina. To date, we have tested a total of six volunteers and these results have been published in scientific medical journals. Following our first phase of human experimentation, we have made significant changes in both the design of the prosthesis and the surgical approach in order to improve the likelihood of success. We are currently preparing for future human testing.