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Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.
Ophthalmology 2016; 123(10):2248-54O

Abstract

PURPOSE

The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP.

DESIGN

Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II.

PARTICIPANTS

Thirty participants in 10 centers in the United States and Europe.

METHODS

The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina.

MAIN OUTCOME MEASURES

The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks.

RESULTS

Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks.

CONCLUSIONS

The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.

Authors+Show Affiliations

Department of Vitreoretinal Surgery, Moorfields Eye Hospital, NHS Foundation Trust, NIHR Moorfields Biomedical Research Centre, London, United Kingdom and Department of Brain Science, University College London (UCL).Second Sight Medical Products, Inc, Sylmar, California. Electronic address: jdorn@secondsight.com.University of Southern California, Los Angeles, California.Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France.Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France; Sorbonne Universities-UPMC Paris-6, and Institut de la Vision, Paris, France; Rothschild Ophthalmology Foundation, Paris, France.Manchester Royal Eye Hospital, Manchester Vision Regeneration (MVR) Laboratory at NIHR/Wellcome Trust Manchester CRF, and Manchester Academic Health Science Centre and Centre for Ophthalmology and Vision Research, Institute of Human Development, University of Manchester, Manchester, United Kingdom.University of Southern California, Los Angeles, California; ELZA Institute, Zurich, Switzerland; Hôpitaux Universitaires de Genève, Geneva, Switzerland.Sorbonne Universities-UPMC Paris-6, and Institut de la Vision, Paris, France; Hôpitaux Universitaires de Genève, Geneva, Switzerland.Hôpitaux Universitaires de Genève, Geneva, Switzerland.Centro de Retina Medica y Quirúrgica, SC, and Tecnologico de Monterrey, Guadalajara, Mexico.Retina Foundation of the Southwest, Dallas, Texas.Texas Retina Associates, Dallas, Texas.Scheie Eye Institute, University of Pennsylvania, Philadelphia, Pennsylvania.University of California, San Francisco, San Francisco, California.University of California, San Francisco, San Francisco, California.University of Southern California, Los Angeles, California; Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts.University of Southern California, Los Angeles, California; Feinberg School of Medicine, Northwestern University, Chicago, Illinois.University of Southern California, Los Angeles, California.Wills Eye Hospital, Philadelphia, Pennsylvania.Wills Eye Hospital, Philadelphia, Pennsylvania.Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland; Wills Eye Hospital, Philadelphia, Pennsylvania.Wills Eye Hospital, Philadelphia, Pennsylvania.Columbia University, New York, and Storm Eye Institute, Charleston, South Carolina.Lighthouse Guild, New York, and Visibility Metrics, LLC, Chappaqua, New York.Second Sight Medical Products, Inc, Sylmar, California.No affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27453256

Citation

da Cruz, Lyndon, et al. "Five-Year Safety and Performance Results From the Argus II Retinal Prosthesis System Clinical Trial." Ophthalmology, vol. 123, no. 10, 2016, pp. 2248-54.
da Cruz L, Dorn JD, Humayun MS, et al. Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial. Ophthalmology. 2016;123(10):2248-54.
da Cruz, L., Dorn, J. D., Humayun, M. S., Dagnelie, G., Handa, J., Barale, P. O., ... Greenberg, R. J. (2016). Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial. Ophthalmology, 123(10), pp. 2248-54. doi:10.1016/j.ophtha.2016.06.049.
da Cruz L, et al. Five-Year Safety and Performance Results From the Argus II Retinal Prosthesis System Clinical Trial. Ophthalmology. 2016;123(10):2248-54. PubMed PMID: 27453256.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial. AU - da Cruz,Lyndon, AU - Dorn,Jessy D, AU - Humayun,Mark S, AU - Dagnelie,Gislin, AU - Handa,James, AU - Barale,Pierre-Olivier, AU - Sahel,José-Alain, AU - Stanga,Paulo E, AU - Hafezi,Farhad, AU - Safran,Avinoam B, AU - Salzmann,Joel, AU - Santos,Arturo, AU - Birch,David, AU - Spencer,Rand, AU - Cideciyan,Artur V, AU - de Juan,Eugene, AU - Duncan,Jacque L, AU - Eliott,Dean, AU - Fawzi,Amani, AU - Olmos de Koo,Lisa C, AU - Ho,Allen C, AU - Brown,Gary, AU - Haller,Julia, AU - Regillo,Carl, AU - Del Priore,Lucian V, AU - Arditi,Aries, AU - Greenberg,Robert J, AU - ,, Y1 - 2016/07/21/ PY - 2016/04/05/received PY - 2016/06/04/revised PY - 2016/06/17/accepted PY - 2016/7/26/entrez PY - 2016/7/28/pubmed PY - 2017/6/27/medline SP - 2248 EP - 54 JF - Ophthalmology JO - Ophthalmology VL - 123 IS - 10 N2 - PURPOSE: The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. DESIGN: Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. PARTICIPANTS: Thirty participants in 10 centers in the United States and Europe. METHODS: The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. MAIN OUTCOME MEASURES: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. RESULTS: Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. CONCLUSIONS: The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/27453256/Five_Year_Safety_and_Performance_Results_from_the_Argus_II_Retinal_Prosthesis_System_Clinical_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(16)30579-6 DB - PRIME DP - Unbound Medicine ER -