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

Initial studies, started in 2002, with six patients and a sixteen electrode device have provided blind subjects with basic object recognition.

Second Sight has now received FDA Investigational Device Exemption (IDE) approval to conduct a study of 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.

Inclusion Criteria:

Patients eligible for consideration in this study are those who:

- Have a confirmed history of Retinitis Pigmentosa 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 fifty (50) years or older at the time of enrollment.

- 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 including one to two follow-up visits per week. Second Sight is sponsoring the study. The study will be conducted at several centers within the United States. 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:
NCT00279500
NCT00407602