Ensayos clínicos

Inclusion Criteria:

• Are adults, age 25 year or older;
• Have severe to profound retinitis pigmentosa;
• Bare light or no light perception in both eyes; if the patient has no residual light perception, then evidence of intact inner layer retina function must be confirmed;
• Have previous history of useful form vision.
• Aphakic or pseudophakic. (If the patient is phakic prior to implant, the natural lens will be removed during the implant procedure.)
• Patients who are willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation;
• Have consented to the implantation of an Argus II Retinal Prosthesis and subsequently consent to participate in this study;
• At the time of the Baseline Visit, do not suffer from non-ophthalmic serious adverse events (e.g. myocardial infarction, etc.) and

Exclusion Criteria:

• Ocular diseases or conditions that could prevent Argus II System from working (e.g. 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 (e.g. 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, and
  • 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.