DESCRIPTION
A retinal prosthesis is a device that replaces lost photoreceptor function by transmitting computer-processed video images to an array of electrodes placed on the retinal surface.
There is ongoing research interest in developing an artificial retina that could potentially restore sight to patients with blindness secondary to retinal diseases, such as retinitis pimentosa, hereditary retinal degeneration, and some forms of age-related macular degeneration. As currently investigated, the artificial retina consists of a small external video camera, held on eyeglass frames, that captures images that are then processed by an externally worn microcomputer. These signals are transmitted to an electrode array implanted in the back of the eye, which in turn stimulates the optic nerve.
Research has begun with a first generation, 16-electrode device (e.g., the ArgusTM 16), which is expected to permit the distinction between the presence and absence of light, and the second generation (e.g., ArgusTM II), which has 60 electrodes. It is hoped that further generation devices, containing more than 1,000 electrodes, will provide more useful vision. The first and second generation devices are currently being studied in 2 Investigational New Device Trials approved by the U.S. Food and Drug Administration (FDA). Second Sight Medical Products and the National Institutes of Health are partnering sponsors for these feasibility studies. At the present time, no device has received final FDA approval.
POLICY
Retinal prostheses are considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Chader et al reported that the 60-electrode device is currently in a phase II/III clinical trial, a 250-electrode unit is “on the drawing board,” and functional vision with a 1000-electrode prosthesis could potentially be achieved within 5-10 years. Initial results from a 4-week implantation study of another retinal prosthesis, the EPI-RET-3, have also been reported.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2011). Retinal prosthesis (9.03.15). Retrieved March 11, 2011 from BlueWeb. (6 articles and / or guidelines reviewed)
Chader, G. J., Weiland, J., & Humayun, M. S. (2009). Artificial vision: Needs, function, and testing of a retinal electronic prosthesis. Progress in Brain Research, 175, 317-332. (Level 3 evidence)
Mokwa, W., Goertz, M., Koch, C., Krisch, I., Trieu, H. K., & Walter, P. (2008). Intraocular epiretinal prosthesis to restore vision in blind humans. Conference proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biological Society, 2008, 5790-5793. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 7/3/2011
MOST RECENT REVIEW DATE: 7/3/2011
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