Artificial retinal devices include various artificial retinas that are used as a method to restore sight for those who have experienced blindness as a result of degenerative retinal diseases (RD).

Investigational and Not Medically Necessary:

The use of artificial retinal devices is considered investigational and not medically necessary for all indications.

Currently artificial retinal devices (Argus 16™ and Argus™ II, Second Sight ® Medical Products, Inc., Sylmar, CA) are being studied by the U.S. Food and Drug Administration (FDA) under Investigational New Device trials. Second Sight Medical Products and the National Institute of Health are jointly participating in these feasibility studies.

In a pilot safety and feasibility study, 6 subjects with vision loss as a result of retinitis pigmentosa (RP) underwent implantation of an artificial silicone retina (ASR) microchip within the subretinal space in the right eye (Chow, 2004). For this study the left eye was maintained as the control. Intraocular pressure (IOP) to greater than 25mm Hg was the only common adverse event reported within the immediate postoperative period. This occurred in 3 of the 6 cases within the 1^st week of the procedure. All received treatment with medication, and the IOP returned to preoperative value. Within the follow-up period of six to eighteen months there was visual improvement reported in all study group subjects as well as surprising visual changes in the retinal area surrounding the implant. There were no severe adverse safety events reported. The author explained that further study is needed to validate these findings and determine the group of individuals that will benefit from the ASR device.

De Balthasar and colleagues (2008), reported on 6 blind subjects due to retinitis pigmentosa who underwent retinal prosthesis implantation. The study protocol received approval by the U.S. Food and Drug Administration as a clinical trial under the investigational device exemption (IDE). The study looked at the perceptual threshold in retinal prosthesis.

There is insufficient published literature to support the safety and effectiveness of the use of artificial retinal devices in restoring vision. Presently, no artificial retinal device has been granted final approval by the FDA.

The retina is a light-sensitive, layered tissue located inside the eye that delivers visual messages via the optic nerve to the brain. Also, there are blood vessels that nourish the retina in an under layer of the eye called the choroid. Another blood supply to the outer aspect of the retina layer is the retinal pigment epithelium (RPE). The retina can develop visual impairment or blindness as a result of a variety of retinal diseases. Retinitis pigmentosa (RP) and some forms of age-related macular degeneration (AMD) include retinal sight–threatening conditions. According to the National Eye Institute (NEI), there are approximately 1 million Americans forty years and over who are currently blind and an estimated 2.4 million who experience visual impairments.

There are two types of retinal implant systems currently under study. Epiretinal implants are positioned on the surface of the retina and receive light signals from an electronic camera mounted in the frame of eye glasses. These electronic images are transmitted to a microchip implanted in the retina. Subretinal implants are positioned behind the retina and receive light directly from the environment. The subretinal implant is a silicone based device containing several thousand micro-electrode tipped microphotodiodes powered by incoming light. The electrical charge produced by these microphotodiodes is designed to alter the membrane potentials of adjacent retinal neurons and simulate how light would normally activate these cells to form visual images. An intact optic nerve pathway is necessary for these devices to function.

Age-Related Macular Degeneration (AMD): A slowly progressive, painless disease affecting the macula that blurs the sharp, central vision needed for "straight-ahead" activities such as reading, sewing, and driving.

Retinitis pigmentosa (RP): A group of hereditary retinal diseases that results in a progressive deterioration of specialized, light-absorbing cells found in the retina, and characterized by advanced visual field loss.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. Chow AY, Chow VY, Packo KH, et al. The artificial silicon retina microchip for the treatment of vision loss from retinitis pigmentosa. Arch Ophthalmol. 2004;122(4):460-469.
2. de Balthasar C, Patel S, Roy A, et al. Factors affecting perceptual thresholds in epiretinal prostheses. Invest Ophthalmol Vis Sci. 2008; 49(6):2303-2314.
3. Mahadevappa M, Weiland JD, Yanai D, et al. Perceptual thresholds and electrode impedance in three retinal prosthesis subjects. IEEE Trans Neural Syst Rehabil Eng. 2005; 13(2):201-206.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Ophthalmologists (AAO). Retinal Panel, Preferred Practice Patterns Committee. Age-related macular degeneration. September 2008. Available at: http://one.aao.org/CE/PracticeGuidelines/PPP.aspx. Accessed on March 07, 2011.
2. Second Sight Medical Products and National Institute of Health. Argus™II Retinal Stimulation System Feasibility Protocol. NLM Identifier: NCT00407602. Last updated on November 10, 2009. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00407602?term=Argus+II+Retinal+Stimulation+system+feasibility&rank=1. Accessed on March 07, 2011.

1. American Academy of Ophthalmologists (AAO). Eye Facts. Retinitis Pigmentosa. 2008 American Academy of Ophthalmologists. For additional information: http://www.aao.org/practice_mgmt/patient_ed/eye_fact_sheets.cfm. Accessed on March 07, 2011.

Argus 16™
Argus™ II
Artificial retinal devices
Artificial silicon retina™ (ASR™)
Retinal implants
Retinal prostheses

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.