Clinical Trials

Inclusion Criteria

• Adults, age 25 years or older
• Has severe to profound retinitis pigmentosa
• Bare light or no light perception in both eyes
  • If patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed
• Has previous history of useful form vision
• Aphakic or pseudophakic
  • If phakic prior to implant, the natural lens will be removed during the implant procedure
• Willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation
• Has consented to the implantation of an Argus II Retinal Prosthesis and subsequently consented to participate in this study
• At time of baseline visit, does not suffer from a non-ophthalmic serious adverse event (e.g. myocardial infarction, etc.) 

Exclusion Criteria

• Ocular diseases or conditions that could prevent Argus II System from working 
  • Optic nerve disease
  • Central retinal artery or vein occlusion
  • History of retinal detachment
  • Trauma
  • Severe strabismus
• Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery 
  • Extremely thin conjunctiva
  • Axial length <20.5 mm or >26 mm
  • Corneal ulcers
  • Etc
• Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity, etc.)
• Inability to tolerate general anesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery
• Metallic or active implantable device(s) (e.g. cochlear implant) in the head
• Pre-disposition to eye rubbing
• Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:
  • Cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease
  • Psychiatric disease including diagnosed forms of depression
  • Does not speak a principal language associated with the region
  • Deafness
• Pregnant or wish to become pregnant during the course of the study
• Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study
• Conditions likely to limit life to less than 1 year from the time of inclusion