A retinal prosthesis is a device that purportedly replaces lost photoreceptor function by transmitting computer-processed video images to an array of electrodes or via light sensors placed in the epiretinal or subretinal space. The artificial retina is being investigated to restore sight to individuals with blindness secondary to retinal diseases such as retinitis pigmentosa, hereditary retinal degeneration, and some forms of age-related macular degeneration. Several models of retinal prostheses are in development in the United States, Europe and Asia. Only the Argus II system has been cleared for use by the U.S. Food and Drug Administration.
Retinal prostheses are considered investigational.
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The Argus II Retinal Prosthesis System (Second Sight Medical Products, Sylmar, CA), received a Humanitarian Device Exemption from the FDA in February 2013.
Agency for Healthcare Research and Quality. (2016). Retinal prostheses in the Medicare population. Retrieved May 26, 2017 from https://www.ahrq.gov/research/findings/ta/index.html.
BlueCross BlueShield Association. Evidence Positioning System. (4:2019). Retinal prosthesis (9.03.15). Retrieved April 30, 2019 from https://www.evidencepositioningsystem.com/. (8 articles and / or guidelines reviewed)
Cheng, D., Greenberg, P., & Borton, D. (2017). Advances in retinal prosthetic research: a systematic review of engineering and clinical characteristics of current prosthetic initiatives. Current Eye Research, 42 (3), 334-347. Abstract retrieved May 26, 2017 from PubMed database.
da Cruz, L., Dorn, J., Humayun, M., Dagnelie, G., Handa, J., Barale, P., et al. (2016). Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial. Ophthalmology, 123 (10), 2248-2254. (Level 3 evidence)
Dagnelie, G., Christopher, P., Arditi, A., da Cruz, L., Duncan, J., Ho, A., et al. (2017). Performance of real-world functional vision tasks by blind subjects improves after implantation with the Argus® II retinal prosthesis system. Clinical and Experimental Ophthalmology, 45, 152-159.
Geruschat, D., Richards, T., Arditi, A., da Cruz, L., Dagnelie, G., Dorn, J., et al. (2016). An analysis of observer-rated functional vision in patients implanted with the Argus II retinal prosthesis system at three years. Clinical and Experimental Optometry, 99 (3), 227-232. Abstract retrieved May 26, 2017 from PubMed database.
Ho, A., Humayun, M., Dorn, J., da Cruz, L., Dagnelie, G., Handa, J., et al. (2015). Long-term results from an epiretinal prosthesis to restore sight to the blind. Ophthalmology, 122 (8), 1547-1554. (Level 3 evidence)
Palmetto Government Benefit Administrators. (2018). Local Coverage Article for ArgusM II retinal prosthesis system (A53044). Retrieved May 29, 2018 from www.cms.gov.
U. S. Food and Drug Administration. (2013, February). Center for Devices and Radiological Health. Argus® II Retinal Prosthesis System - H110002. Retrieved April 16, 2014 from http://www.accessdata.fda.gov.
ORIGINAL EFFECTIVE DATE: 7/3/2011
MOST RECENT REVIEW DATE: 5/9/2019
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