Worldwide Argus II implantation: recommendations to optimize patient outcomes

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Abstract

Background

A position paper based on the collective experiences of Argus II Retinal Prosthesis System investigators to review strategies to optimize outcomes in patients with retinitis pigmentosa undergoing retinal prosthesis implantation.

Methods

Retinal surgeons, device programmers, and rehabilitation specialists from Europe, Canada, Middle East, and the United States were convened to the first international Argus II Investigator Meeting held in Ann Arbor, MI in March 2015. The recommendations from the collective experiences were collected. Factors associated with successful outcomes were determined.

Results

Factors leading to successful outcomes begin with appropriate patient selection, expectation counseling, and preoperative retinal assessment. Challenges to surgical implantation include presence of staphyloma and inadequate Tenon’s capsule or conjunctiva. Modified surgical technique may reduce risks of complications such as hypotony and conjunctival erosion. Rehabilitation efforts and correlation with validated outcome measures following implantation are critical.

Conclusions

Bringing together Argus II investigators allowed the identification of strategies to optimize patient outcomes. Establishing an on-line collaborative network will foster coordinated research efforts to advance outcome assessment and rehabilitation strategies.

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Most cited references 14

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Interim results from the international trial of Second Sight's visual prosthesis.

Mark S Humayun, Jessy Dorn, Lyndon da Cruz … (2012)

This study evaluated the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc., Sylmar, CA) in blind subjects with severe outer retinal degeneration. Single-arm, prospective, multicenter clinical trial. Thirty subjects were enrolled in the United States and Europe between June 6, 2007, and August 11, 2009. All subjects were followed up for a minimum of 6 months and up to 2.7 years. The electronic stimulator and antenna of the implant were sutured onto the sclera using an encircling silicone band. Next, a pars plana vitrectomy was performed, and the electrode array and cable were introduced into the eye via a pars plana sclerotomy. The microelectrode array then was tacked to the epiretinal surface. The primary safety end points for the trial were the number, severity, and relation of adverse events. Principal performance end points were assessments of visual function as well as performance on orientation and mobility tasks. Subjects performed statistically better with the system on versus off in the following tasks: object localization (96% of subjects), motion discrimination (57%), and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects' mean performance on orientation and mobility tasks was significantly better when the system was on versus off. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was treated successfully in all subjects except in one, who required explantation of the device without further complications. The long-term safety results of Second Sight's retinal prosthesis system are acceptable, and most subjects with profound visual loss perform better on visual tasks with system than without it. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss

Lyndon da Cruz, Brian F Coley, Jessy Dorn … (2013)

Background Retinal prosthesis systems (RPS) are a novel treatment for profound vision loss in outer retinal dystrophies. Ideal prostheses would offer stable, long-term retinal stimulation and reproducible spatial resolution in a portable form appropriate for daily life. Methods We report a prospective, internally controlled, multicentre trial of the Argus II system. Twenty-eight subjects with light perception vision received a retinal implant. Controlled, closed-group, forced-choice letter identification, and, open-choice two-, three- and four-letter word identification tests were carried out. Results The mean±SD percentage correct letter identification for 21 subjects tested were: letters L, T, E, J, F, H, I, U, 72.3±24.6% system on and 17.7±12.9% system off; letters A, Z, Q, V, N, W, O, C, D, M, 55.0±27.4% system on and 11.8%±10.7% system off, and letters K, R, G, X, B, Y, S, P, 51.7±28.9% system on and 15.3±7.4% system off. (p<0.001 for all groups). A subgroup of six subjects was able to consistently read letters of reduced size, the smallest measuring 0.9 cm (1.7°) at 30 cm, and four subjects correctly identify unrehearsed two-, three- and four-letter words. Average implant duration was 19.9 months. Conclusions Multiple blind subjects fitted with the Argus II system consistently identified letters and words using the device, indicating reproducible spatial resolution. This, in combination with stable, long-term function, represents significant progress in the evolution of artificial sight.

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Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind.

Allen C. Ho, Mark S Humayun, Jessy Dorn … (2015)

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations leading to blindness due to photoreceptor loss. Retinitis pigmentosa is a rare disease, affecting only approximately 100 000 people in the United States. There is no cure and no approved medical therapy to slow or reverse RP. The purpose of this clinical trial was to evaluate the safety, reliability, and benefit of the Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) in restoring some visual function to subjects completely blind from RP. We report clinical trial results at 1 and 3 years after implantation.

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Author and article information

Contributors

K. Thiran Jayasundera: 734-615-2479 , 734-232-8181 , thiran@umich.edu

Journal

Journal ID (nlm-ta): BMC Ophthalmol

Journal ID (iso-abbrev): BMC Ophthalmol

Title: BMC Ophthalmology

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2415

Publication date (Electronic): 6 May 2016

Publication date PMC-release: 6 May 2016

Publication date Collection: 2016

Volume: 16

Electronic Location Identifier: 52

Affiliations

[ ]Kellogg Eye Center, University of Michigan, Ann Arbor, MI USA

[ ]Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD USA

[ ]Retina Foundation of the Southwest, Dallas, TX USA

[ ]Second Sight Medical Products, Inc., Sylmar, CA USA

[ ]University of California, San Francisco, San Francisco, CA USA

[ ]The University of Toronto, Toronto, Canada

[ ]Focal Point, Bristol, UK

[ ]Bascom Palmer Eye Institute, University of Miami, Miami, FL USA

[ ]Duke University Eye Center, Durham, NC USA

[ ]Wills Eye Hospital, Philadelphia, PA USA

[ ]Retina Center of Ohio, South Euclid, OH USA

[ ]Department of Ophthalmology, Mayo Clinic, Rochester, MN USA

[ ]University of Illinois at Chicago Eye and Ear Infirmary, Chicago, IL USA

[ ]Private Practice, Toronto, Canada

[ ]Canadian National Institute for the Blind, Toronto, Canada

[ ]Department of Ophthalmology, RWTH Aachen University, Aachen, Germany

[ ]Department of Ophthalmology, University of Southern California, Los Angeles, CA USA

[ ]Emory Eye Center, Atlanta, GA USA

Article

Publisher ID: 225

DOI: 10.1186/s12886-016-0225-1

PMC ID: 4858839

PubMed ID: 27154461

SO-VID: 77841aaf-8716-4500-97b3-2a0c776ff70f

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 8 January 2016

Date accepted : 21 April 2016

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100005242, Heed Ophthalmic Foundation;

Funded by: Foundation for Fighting Blindness

Funded by: Karen and William Barnett Chair in Ophthalmology

Funded by: Arsht Hope for Vision Retinal Degeneration Laboratory

Funded by: FundRef http://dx.doi.org/10.13039/100000002, National Institutes of Health;

Award ID: EY01792

Award ID: EY09076

Award Recipient : David G. Birch Jennifer I. Lim

Funded by: FundRef http://dx.doi.org/10.13039/100001818, Research to Prevent Blindness;

Funded by: FundRef http://dx.doi.org/10.13039/100000002, National Institutes of Health;

Award ID: EY09076

Award Recipient : Kirsten G. Locke

Funded by: Second Sight Medical Products

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ScienceOpen disciplines: Ophthalmology & Optometry

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ScienceOpen disciplines: Ophthalmology & Optometry

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Worldwide Argus II implantation: recommendations to optimize patient outcomes

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Karger: Ophthalmology

Most cited references 14

Interim results from the international trial of Second Sight's visual prosthesis.

The Argus II epiretinal prosthesis system allows letter and word reading and long-term function in patients with profound vision loss

Long-Term Results from an Epiretinal Prosthesis to Restore Sight to the Blind.

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