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Sight Enhancing Retinal Implant Approved by the FDA

Sight Enhancing Retinal Implant Approved by the FDA Forget about glasses or contacts, a new vision enhancing “bionic eye” implant has been approved by the FDA. The device was designed to aid those with a genetic disorder called retinitis pigmentosa and seeks to help those affected regain some of their lost vision. The disease is believed to impact about 100,000 people in the United States with more than 1,000 new patients being diagnosed each year. How will this bionic eye implant transform eye care? Are implanted vision aids likely to be created for other visual conditions?

What is Retinitis Pigmentosa?
Retinitis pigmentosa is an inherited degenerative eye disease that damages the rods and cones located in the back of the eye, called the retina. Rods provide night vision and peripheral vision and cones provide color vision and central vision. In retinitis pigmentosa, rods are affected more than cones. It typically appears early in life during childhood or adolescence starting with symptoms such as blurring of vision, slow adjustments from light to dark, night blindness and then progresses to peripheral vision loss, tunnel vision. Generally those exhibiting the disease later in life experience a more rapid degeneration of eye sight.

How Does the Implant Work?
The device is called the Argus II Retinal Prosthesis System. It features three parts: a small device implanted into the eye, a tiny video camera that attaches to glasses and a video processing unit that the patient carries with them.

The device uses complex technologies to aid vision. It doesn’t provide completely restored vision, but can take a person from being almost blind to being able to see shapes once again. It uses a tiny video camera that attaches to a pair of glasses to transmit signals into electrodes sewn into the eye. These signals are then transmitted into the brain through the optic nerve.

While the new implant device will only help those with this disease, which is quite rare, it will make a huge difference in the lives of those with retinitis pigmentosa. The current approval by the FDA is very limited in scope allowing for fewer than 4,000 implants each year. Only those over the age of 25 can receive the implant. Patients must have severe retinal pigmentosa, but still possess some vision either being able to see light or shapes.

The device doesn’t restore vision, but it can take someone from almost no vision to low vision, which enables them to complete a variety of tasks they might otherwise be unable to accomplish. For example a person with low vision may be able to see the lines in a crosswalk, allowing them to once again be able to walk around town safely. It can also help patients see silhouettes, shapes and movement.

The Future of the Implant
The device is software based, which means that researchers will be able to update the device as new developments and technologies present themselves. The company behind the device expects to offer upgrades to all implanted patients periodically. Future planned upgrades could include color vision and sharper images. Additionally the company plans to create a new improved version of the implant at some point in the future.

How Much Does the Bionic Implant Cost?
Like many new medical technologies the bionic implant is pricey. In Europe the cost is over $100,000 along with about $16,000 for the operation. In the U.S. the price is expected to exceed $100,000. Insurance may cover the cost of the implants. Currently many insurance plans cover the device in Europe and the company is working with U.S. insurers to get the device covered.

The implant has been used in Europe for several years now and is just making its way into the U.S., thanks to the recent FDA approval.

The Approval Process
Receiving FDA approval was an important step to being able to offer this device to patients in the United States. To gain approval the device underwent extensive testing including a clinical trial. During the trial 30 patients received the device. Of these patients 19 experienced no significant side effects while 11 had serious complications including conjunctiva, retinal detachment and inflammation. Most patients were able to perform basic activities (including detecting motion, recognizing large letters, walking on a sidewalk and matching socks) more effectively with the device than without.

To learn more about the Argus II Retinal Prosthesis System check out this short video made by Second Sight, the company that created the device.

This new eye implant holds promise for both the treatment of retinitis pigmentosa and other eye conditions. While only approved for use in specific patients, the technologies developed may lead to the creation of additional implants to help those with other types of vision loss.

What eye conditions would you like to see an implant developed for? Would you ever consider a “bionic” eye implant like this one?

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