How to Participate in Retinal Implant Clinical Trials

Candidates affected by a group of inherited eye diseases known as retinitis pigmentosa (RP) are being actively recruited for retinal implant clinical trials.

These clinical studies are being conducted by the Doheny Eye Institute at the University of Southern California Medical Center and other select sites in the United States. Testing will evaluate the safety and usefulness of Argus™ II, the latest model of a retinal prosthesis, in providing visual function to blind subjects with severe-to-profound RP.

Individuals interested in enrolling as implant candidates in this clinical trial must

• Have a confirmed history of retinitis pigmentosa, with remaining visual acuity of bare light perception or worse in both eyes.
• Have functional ganglion cells and optic nerve, as determined by a measurable electrically evoked response or documented light perception.
• Have a history of prior useful vision.
• Be at least 25 (USA, Switzerland) or 18 (France, UK, Mexico) years old.
• Reside within 2 hours of land transport from a clinical site.
• Be willing and able to comply with protocol testing and followup requirements.

The study requires each subject to be followed for at least 3 years, with routine visits to the implanting center for testing and programming the device. Those with optic-nerve disease, glaucoma, diabetic retinopathy, ocular trauma, infectious or inflammatory retinal diseases, or a history of retinal detachment are not suitable candidates.

For enrollment contacts and a list of participating sites, see the U.S. National Institutes of Health clinical trials website at http://clinicaltrials.gov/show/NCT00407602.