Second Sight is leading a new field in the development of a retinal prosthesis with the hope that this research will lead to a device that provides useful artificial vision to blind individuals.

In our first study, which began in 2002, a sixteen electrode device (Argus™ I) was implanted in 6 profoundly blind subjects in Los Angeles, California. This device provided these subjects with basic object recognition.

In 2006, Second Sight began a study with the new Argus II Retinal Stimulation System - a second generation retinal prosthesis designed with 60 electrodes. This long-term clinical trial is being conducted to evaluate the feasibility of this new device to elicit visual percepts in blind subjects. Second Sight is conducting this study in several countries, including the United States, France, Mexico, Switzerland, and the United Kingdom. As of February 2009, 18 subjects have been implanted with the Argus II device.

Inclusion Criteria:

Patients eligible for consideration in this study are those who:

- Have a confirmed history of Retinitis Pigmentosa or outer retinal degeneration (outside the U.S.) with remaining visual acuity of bare light perception or no light perception in both eyes.

- Have functional ganglion cells and optic nerve as determined by documented light perception or a measurable electrically evoked response.

- Have a history of former useful vision in the worse-seeing eye.

- Are at least the following age at the time of enrollment: 50 (United States), 25 (Switzerland) or 18 (France, Mexico and the UK).

- Reside within two (2) hours distance (by ground transportation) of the investigational site.

- Are willing and able to comply with the protocol testing and follow-up requirements.

General Information:

The study requires participation for 36 months, during which time patients will make routine visits to the local clinical site for follow-up testing and evaluation. Second Sight is sponsoring the study. The study is being conducted at several centers within the United States, France, Mexico, Switzerland and the UK. For enrollment contacts and a list of participating sites, please visit the NIH Clinical Trials website (http://clinicaltrials.gov/show/NCT00407602).

For additional information, please email Patient Information at Second Sight, or call our patient information line at 818-833-5027.

CAUTION: Investigational Device.
Limited by United States law to investigational use only.

Study registration information:
Argus I: NCT00279500
Argus II: NCT00407602