• Visual acuity
  
• Safety
  

• Activities of daily living
  
• Quality of life
  
• Mobility
  

Inclusion Criteria:

• A confirmed history of retinitis pigmentosa (outer retinal degeneration - France only) with remaining visual acuity of bare light perception (2.3 logMAR - France only) 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) (eighteen (18) - France only) 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.