Argus® II Retinal Prosthesis System Post-Market Surveillance Study

Subjects will be selected from eligible patients who have been implanted with the Argus II retinal prosthesis at the enrolling center.

Inclusion Criteria:

Adults, age 25 year or older

• with severe to profound outer retinal degeneration (not including Age-related Macular Degeneration)
• Have some residual light perception. If no residual light perception remains, the retina must be able to respond to electrical stimulation;
• Have previous history of useful form vision
• Have consented to participate in the study
• Had an Argus II Retinal Prosthesis surgically implanted 14 days (± 7 days) prior to enrollment (at Baseline Visit) in the study
• At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. coma, myocardial infarction, etc.).

Exclusion Criteria:

• Ocular diseases or conditions that could prevent Argus II from working (e.g. optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, severe strabismus, etc.)
• Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length <20.5 mm or > 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.)
• Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g. corneal opacity)
• 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, and
  • deafness or selective frequency hearing loss that prevents hearing device alarms and alerts
• Participants who are pregnant or wish to become pregnant during the course of the study
• Participation 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.