The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with severe to profound retinitis pigmentosa.

Inclusion Criteria:

• A confirmed history of retinitis pigmentosa with remaining visual acuity of bare light perception or worse in both eyes.
• Functional ganglion cells and optic nerve as determined by a measurable electrically evoked response or documented light perception.
• A history of former useful form vision in the worse-seeing eye.
• Must be fifty (50) years or older at the time of enrollment.
• Must reside within two (2) hours distance (by ground transportation) of the investigational site.
• Must be willing and able to comply with the protocol testing and follow-up requirements.

Exclusion Criteria:

• Optic Nerve disease

  • History of glaucoma
  • Optic neuropathy or other confirmed damage to optic nerve or visual cortex damage

• Diseases or conditions that effect retinal function including but not limited to:

  • Central retinal artery/vein occlusion (CRAO or CRVO)
  • End-stage diabetic retinopathy
  • Retinal detachment or history of retinal detachment
  • Trauma
  • Infectious or inflammatory retinal diseases
• Diseases or conditions that prevent adequate visualization of the retina including, but not limited to corneal degeneration that cannot be resolved before implant.
• Diseases or conditions of the anterior segment that prevent the ability to adequately perform the physical examination including but not limited to trauma or lid malpositions.
• Diseases of the ocular surface including but not limited to keratitis sicca.
• An ocular condition that predisposes the subject to eye rubbing.

• Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:

  • Neurologic disease including diagnosed forms of dementia and/or progressive neurologic disease
  • Psychiatric Disease including diagnosed forms of depression
  • Non-English speaking including American Sign language
  • Deafness
• Pregnancy
• Subject has another active implantable device (e.g. cochlear implant), or any form of metallic implant in the head
• Subjects with a history of tobacco use greater than twenty pack-years.
• Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study
• Any health concern that makes general anesthesia inadvisable.
• Subject has unrealistic expectations of the implant.