Bionic eye implants approvedBionic eye implants approved
14 Feb 2013 WASHINGTON — Adults with a rare eye disease may regain the ability to do daily tasks such as walking on the sidewalk from the first implanted artificial retina to win U.S. regulatory approval.
The Food and Drug Administration cleared the Argus II Retinal Prosthesis System from closely held Sylmar, Calif.- based Second Sight Medical Products Inc. to replace the function of degenerated cells in the retina, the agency said Thursday in a statement. The system helps adult patients with advanced retinitis pigmentosa, which damages light-sensitive cells that line the retina located at the back of the eye, causing a gradual loss of vision that may lead to blindness.
The device consists of a video camera, a transmitter mounted on a pair of eyeglasses, a video processing unit and an implanted retinal prosthesis. The processing unit transforms images into electronic data that is transmitted to the artificial retina, the FDA said.
“This is a game changer in sight-affecting diseases, that represents a huge step forward for the field and for these patients who were without any available treatment options until now,” Robert Greenberg, president and chief executive officer of Second Sight, said in a statement.
The system won’t restore sight. It gives patients the ability to perceive the difference between light and dark, the FDA said. A clinical study of 30 people showed the Argus helped patients recognize large letters or words, detect street curbs, walk on a sidewalk without falling and match black, gray and white socks.
Of the 30 patients in the study who were followed for two years, 19 experienced no side effects, while others experienced adverse events such as retina detachment, surgical wounds that split open and erosion of the clear covering of their eyeballs.
The Department of Energy, the National Eye Institute of the National Institutes of Health and the National Science Foundation collaborated to provide $100 million to support the development of the Argus system, the FDA said.
John 6:26 Jesus answered them and said, Verily, verily, I say unto you, Ye seek me, not because ye saw the miracles, but because ye did eat of the loaves, and were filled.
Joh 6:27 Labour not for the meat which perisheth, but for that meat which endureth unto everlasting life, which the Son of man shall give unto you: for him hath God the Father sealed.
Joh 6:28 Then said they unto him, What shall we do, that we might work the works of God?
Joh 6:29 Jesus answered and said unto them, This is the work of God, that ye believe on him whom he hath sent.
Mat 6:19 Lay not up for yourselves treasures upon earth, where moth and rust doth corrupt, and where thieves break through and steal:
Mat 6:20 But lay up for yourselves treasures in heaven, where neither moth nor rust doth corrupt, and where thieves do not break through nor steal:
Joh_8:12 Then spake Jesus again unto them, saying, I am the light of the world: he that followeth me shall not walk in darkness, but shall have the light of life.
'Bionic Eyes' Help People With Genetic Blindness
People who have lost their vision as a result of a rare genetic disease may soon be able to have some of their sight restored, thanks to the first FDA-approved eye implant.
The implant, named the Argus II, works to wirelessly transmit images to the brain through a video camera and transmitter on a pair of glasses.
The FDA approved the device from Second Sight Medical Products for patients 25 years and older Thursday, The Associated Press reported.
While the implant does not restore vision, the FDA said the device might help the blind to see by allowing them "to detect light and dark in the environment."
Dr. Mark Humayn, who has been working on the Argus II for the past 25 years, told "Good Morning America" he committed himself "to developing a new way and a new approach so that those that are blind can have a foreseeable solution."
"One of the things I can do now is laundry," Kathy Blake told "Good Morning America." "My husband had to put the colored clothing in, and with the glasses, I'm able to do that myself."
Blake, 61, who has been blind for 23 years, underwent a two-hour surgery and said she now uses the glasses to "help [her] be more outdoor with mobility, walking."
The device is only approved for retintis pigmentosa, a disorder that causes gradual blindness and affects 100,0000 people in the United States.
If successful, the device could eventually be used to treat millions with other vision disorders.
"I think that the future for this is going to be big," Blake said.
Mat 6:22 The light of the body is the eye: if therefore thine eye be single, thy whole body shall be full of light.
Mat 6:23 But if thine eye be evil, thy whole body shall be full of darkness. If therefore the light that is in thee be darkness, how great is that darkness!
Rom 8:24 For we are saved by hope: but hope that is seen is not hope: for what a man seeth, why doth he yet hope for?
Rom 8:25 But if we hope for that we see not, then do we with patience wait for it.
Michigan man among 1st in US to get 'bionic eye'
ANN ARBOR, Mich. (AP) — A degenerative eye disease slowly robbed Roger Pontz of his vision.
Diagnosed with retinitis pigmentosa as a teenager, Pontz has been almost completely blind for years. Now, thanks to a high-tech procedure that involved the surgical implantation of a "bionic eye," he has regained enough of his eyesight to catch small glimpses of his wife, grandson and cat.
"It's awesome. It's exciting — seeing something new every day," Pontz said during a recent appointment at the University of Michigan Kellogg Eye Center. The 55-year-old former competitive weightlifter and factory worker is one of four people in the U.S. to receive an artificial retina since the Food and Drug Administration signed off on its use last year.
The facility in Ann Arbor has been the site of all four such surgeries since FDA approval. A fifth is scheduled for next month.
Retinitis pigmentosa is an inherited disease that causes slow but progressive vision loss due to a gradual loss of the light-sensitive retinal cells called rods and cones. Patients experience loss of side vision and night vision, then central vision, which can result in near blindness.
Not all of the 100,000 or so people in the U.S. with retinitis pigmentosa can benefit from the bionic eye. An estimated 10,000 have vision low enough, said Dr. Brian Mech, an executive with Second Sight Medical Products Inc., the Sylmar, Calif.-based company that makes the device. Of those, about 7,500 are eligible for the surgery.
The artificial implant in Pontz's left eye is part of a system developed by Second Sight that includes a small video camera and transmitter housed in a pair of glasses.
Images from the camera are converted into a series of electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. The pulses stimulate the retina's remaining healthy cells, causing them to relay the signal to the optic nerve.
The visual information then moves to the brain, where it is translated into patterns of light that can be recognized and interpreted, allowing the patient to regain some visual function.
When wearing the glasses, which Pontz refers to as his "eyes," he can identify and grab his cat and figure out that a flash of light is his grandson hightailing it to the kitchen.
The visual improvement is sometimes startling for Pontz and his wife, Terri, who is just as amazed at her husband's progress as he is.
"I said something I never thought I'd say: 'Stop staring at me while I'm eating,'" Terri Pontz said.
She drives her husband the nearly 200 miles from tiny Reed City, Mich., to Ann Arbor for check-ups and visits with occupational therapist Ashley Howson, who helps Roger Pontz reawaken his visual memory and learn techniques needed to make the most of his new vision.
At the recent visit, Howson handed Pontz white and black plates, instructed him to move them back and forth in front of light and dark backgrounds and asked that he determine their color.
Back home, Terri Pontz helps her husband practice the techniques he learns in Ann Arbor.
For them, the long hours on the road and the homework assignments are a blessing.
"What's it worth to see again? It's worth everything," Terri Pontz said.
The artificial retina procedure has been performed several-dozen times over the past few years in Europe, and the expectation is that it will find similar success in the U.S., where the University of Michigan is one of 12 centers accepting consultations for patients.
Candidates for the retinal prosthesis must be 25 or older with end-stage retinitis pigmentosa that has progressed to the point of having "bare light" or no light perception in both eyes.
Dr. Thiran Jayasundera, one of two physicians who performed the 4.5-hour surgery on Roger Pontz, is scheduled to discuss his experiences with the retinal prosthesis process during a meeting of the American Society of Cataract and Refractive Surgery on Friday in Boston. He calls it a "game-changer."
Pontz agrees: "I can walk through the house with ease. If that's all I get out of this, it'd be great."
John 9:39 And Jesus said, For judgment I am come into this world, that they which see not might see; and that they which see might be made blind.
Joh 9:40 And some of the Pharisees which were with him heard these words, and said unto him, Are we blind also?
Joh 9:41 Jesus said unto them, If ye were blind, ye should have no sin: but now ye say, We see; therefore your sin remaineth.