New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-000269
    NCT ID: NCT01860092
    Sponsor Protocol Number: PM-02-01

About this study

This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States.

Safety data will be monitored to ensure continued acceptability of risks to study subjects. The utility (i.e. visual function and functional vision) and reliability of Argus II System will also be evaluated.

There is no study hypothesis.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Raymond Iezzi, M.D.

Open for enrollment

Contact information:

Betsy Baker

(507)266-5613

Baker.Betsy@mayo.edu

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CLS-20119834

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