Original articleInterim Results from the International Trial of Second Sight's Visual Prosthesis
Section snippets
Statement of Compliance
This multicenter feasibility study for Second Sight's retinal prosthesis system is being conducted in accordance with the Declaration of Helsinki and the national regulations for medical device clinical trials in the countries in which the study is being conducted. The study has been approved by the national ministries of health in these countries and the ethics committees or institutional review boards of participating institutions. All subjects signed informed consent to participate. The
Surgery
If the subjects' eyes did not have equal visual acuity at baseline, implantation was performed in the worse-seeing eye. If the subjects' eyes had equal visual acuity, the right eye was selected for implantation. Twenty-six subjects were implanted in the right eye, and 4 were implanted in the left eye.
During the implantation procedure, 67% of subjects had their natural lens removed via clear cornea phacoemulsification (with the exception of pars plana lensectomy in 2 cases) and they were left
Discussion
This study represents 45.6 cumulative subject-years in 30 human subjects implanted with the Argus II Retinal Prosthesis System. There are no other suitable retinal prostheses with which the safety or efficacy of this system can be compared. Although other retinal prostheses currently are being developed by both commercial and academic entities, none of these devices are commercially approved, none are approved for longer than 1 month's implantation, few are even being subject to clinical trial
Acknowledgment
The authors thank Suber Huang, MD, the independent medical safety monitor for this study.
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Manuscript no. 2011-408.
The members of the Argus II Study Group are listed in Appendix 1 (available online at http://aaojournal.org).
Financial Disclosure(s): Mark S. Humayun - Equity owner - Second Sight Medical Products, Inc.; Employee - an institution that receives funds from Second Sight Medical Products, Inc.
Jessy D. Dorn - Employee and Equity owner - Second Sight Medical Products, Inc.
Robert J. Greenberg - Employee and Equity owner - Second Sight Medical Products, Inc.
Aries Arditi - Consultant - Second Sight Medical Products, Inc.; Employee - an institution that receives funds from Second Sight Medical Products, Inc.
Artur V. Cideciyan - Employee - an institution that receives funds from Second Sight Medical Products, Inc.
Lyndon da Cruz - Employee - an institution that receives funds from Second Sight Medical Products, Inc.
Gislin Dagnelie - Employee - an institution that receives funds from Second Sight Medical Products, Inc.
Dean Eliott - Employee - an institution that receives funds from Second Sight Medical Products, Inc.
Eugene Filley - Employee - an institution that receives funds from Second Sight Medical Products, Inc.
Avinoam B. Safran - Employee - an institution that receives funds from Second Sight Medical Products, Inc.
José-Alain Sahel - Employee - an institution that receives funds from Second Sight Medical Products, Inc.
Supported by the National Institutes of Health, Bethesda, Maryland (grant no.: 5R01EY012893-10 [RJG]). Sponsored by Second Sight Medical Products, Inc., Sylmar, California. The sponsor participated in the design of the study, conducting the study, data collection, data management, data analysis, interpretation of the data, preparation, and review of the manuscript.
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Group members listed online in Appendix 1 (available at http://aaojournal.org).