Argus® II Retinal Prosthesis System Post-Market Surveillance Study

Overview

This post-market surveillance study is conducted in the European Economic Area where Argus II has been CE certified for use in outer retinal degeneration patients.

Full Title of Study: “Argus® II Retinal Prosthesis System Post-Market Surveillance Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 31, 2020

Detailed Description

This study is being conducted to monitor the use of Argus II in a larger population than available within pre-market approval studies. Safety data will be monitored to ensure continued acceptability of risks to study participants, and an attempt will be made to include all eligible and willing participants implanted with Argus II. Measures of visual function that may contribute to device improvements will also be gathered and evaluated.

Arms, Groups and Cohorts

  • Argus II Retinal Prosthesis
    • Patients implanted with an Argus II Retinal Prosthesis

Clinical Trial Outcome Measures

Primary Measures

  • adverse events
    • Time Frame: up to 3 years from time of implantation
    • nature and rate of adverse events

Secondary Measures

  • visual function
    • Time Frame: up to 3 years from time of implantation
    • Square localization, direction of motion, grating visual acuity

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Sight Medical Products
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne-Marie Ripley, Study Director, Second Sight Medical Products

References

da Cruz L, Coley BF, Dorn J, Merlini F, Filley E, Christopher P, Chen FK, Wuyyuru V, Sahel J, Stanga P, Humayun M, Greenberg RJ, Dagnelie G; Argus II Study Group. The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss. Br J Ophthalmol. 2013 May;97(5):632-6. doi: 10.1136/bjophthalmol-2012-301525. Epub 2013 Feb 20.

Weiland JD, Faraji B, Greenberg RJ, Humayun MS, Shellock FG. Assessment of MRI issues for the Argus II retinal prosthesis. Magn Reson Imaging. 2012 Apr;30(3):382-9. doi: 10.1016/j.mri.2011.12.005. Epub 2012 Jan 20.

Citations Reporting on Results

Schaffrath K, Schellhase H, Walter P, Augustin A, Chizzolini M, Kirchhof B, Grisanti S, Wiedemann P, Szurman P, Richard G, Greenberg RJ, Dorn JD, Parmeggiani F, Rizzo S. One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis: A Postapproval Study. JAMA Ophthalmol. 2019 May 30. doi: 10.1001/jamaophthalmol.2019.1476. [Epub ahead of print]

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.