June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Argus II Retinal Prosthesis System Post-Approval US Cohort 1 Year Outcomes
Author Affiliations & Notes
  • Aleksandra V Rachitskaya
    Ophthalmology, Cole Eye Institute, Cleveland, Ohio, United States
  • Jessy Dana Dorn
    Second Sight, Sylmar, California, United States
  • Hossein Ameri
    USC Roski Eye Institute, Los Angeles, California, United States
  • David G Birch
    Retina Foundation of the Southwest, Dallas, Texas, United States
  • Raymond Iezzi
    Mayo Health System, Rochester, Minnesota, United States
  • Allen Ho
    Mid Atlantic Retina, Plymouth Meeting, Pennsylvania, United States
  • Thiran Jayasundera
    University of Michigan Kellogg Eye Center, Ann Arbor, Michigan, United States
  • Gregg Kokame
    Retina Consultants of Hawaii, Honolulu , Hawaii, United States
  • Jennifer I Lim
    University of Illinois, Eye and Ear Infirmary, Chicago, Illinois, United States
  • Naresh Mandava
    University of Colorado School of Medicine, Aurora, Colorado, United States
  • Lejla Vajzovic
    Duke University Eye Center, Durham, North Carolina, United States
  • Jiong Yan
    Emory Eye Center, Atlanta, Georgia, United States
  • Meghan J Marino
    Ophthalmology, Cole Eye Institute, Cleveland, Ohio, United States
  • Alex Yuan
    Ophthalmology, Cole Eye Institute, Cleveland, Ohio, United States
  • Footnotes
    Commercial Relationships   Aleksandra Rachitskaya, None; Jessy Dorn, Second Sight (E); Hossein Ameri, None; David Birch, None; Raymond Iezzi, None; Allen Ho, None; Thiran Jayasundera, Second Sight (C); Gregg Kokame, Second Sight (C); Jennifer Lim, None; Naresh Mandava, None; Lejla Vajzovic, None; Jiong Yan, None; Meghan Marino, Second Sight (C); Alex Yuan, None
  • Footnotes
    Support  This study was supported in part by the NIH-NEI P30 Core Grant (IP30EY025585-01A1) and Unrestricted Grant from The Research to Prevent Blindness, Inc., awarded to the Cole Eye Institute.
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 4264. doi:
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      Aleksandra V Rachitskaya, Jessy Dana Dorn, Hossein Ameri, David G Birch, Raymond Iezzi, Allen Ho, Thiran Jayasundera, Gregg Kokame, Jennifer I Lim, Naresh Mandava, Lejla Vajzovic, Jiong Yan, Meghan J Marino, Alex Yuan; Argus II Retinal Prosthesis System Post-Approval US Cohort 1 Year Outcomes. Invest. Ophthalmol. Vis. Sci. 2017;58(8):4264.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : The Argus II Retinal Prosthesis System is the only approved treatment in the United States for patients with advanced retinitis pigmentosa and bare light perception vision. This prospective post-marketing surveillance study is the first report to evaluate the real world clinical outcomes of Argus II patients in the US.

Methods : We analyzed the patient demographic, intraoperative and postoperative serious adverse events (SEAs), and visual function performance including square localization, direction of motion, and grating visual acuity.

Results : Twenty-six patients (8 females and 18 males) in the Argus II post-approval study with at least one year of follow up as of October 31, 2016 were included for analysis. Average age at the time of surgery was 64 years old (range: 44-88). There were zero implant failures and zero explants. Five serious adverse events were device- or procedure-related as of October 31, 2016. There was a statistically significant improvement in Square Localization mean error was statistically significantly less with the System ON than when patients used only their residual vision (system OFF) in 45% (3 months), 47% (6 months), and 56% (12 months) of patients. Similarly, Direction of Motion was better with the System ON than with system OFF in 43% (3 months), 39% (6 months), and 29% (12 months) of patients. In the implanted eye, 14%-23% of patients had logMAR vision better than 2.9 with the device ON versus 0% with the device OFF at 3, 6, and 12 months.

Conclusions : In a post-approval setting, the Argus II appears to be safe and results in improved visual function in patients with advanced retinitis pigmentosa.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.


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