A Study of Treatment with the Argus® II Retinal Prosthesis System

Overview

About this study

The purpose of this study is to assess the effectiveness of the use of the Argus II retinal prothesis system in a larger US population than was available previously, within pre-approval studies.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Raymond Iezzi, M.D.

Closed for enrollment

Contact information:

Heidi Rubin CCRP

(507)538-8119

rubin.heidi@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20306494

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