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Washington: The US Food and Drug Administration (FDA) has approved a "bionic
retina", called Argus II, the nation's first implanted device for
the blind which allows some patients to see well enough to read
large letters and detect large images and movement.
"This is truly an exciting and historic moment in the drive to
restore vision in people with advanced retinal degenerative
diseases," said Stephen Rose, chief research officer of the
Fighting Blindness Foundation.
"By restoring some basic vision, the Argus II gives people
independence, mobility and, ultimately, improved quality of life,"
he said.
The Argus II includes a small video camera and transmitter mounted
on a pair of eye-glasses, a video processing unit and electrodes
that are implanted onto the patient's retina. Together, they
replicate the action of cells that have degenerated in patients
with advanced retinitis pigmentosa (RP).
An estimated 100,000 people in the US have RP.
"Without the system, I wouldn't be able to see anything at all,
and if you were in front of me and you moved left and right, I'm
not going to realise any of this," said Elias Konstantopolous, who
has been using the device through clinical trials.
"When you have nothing, this is something. It's a lot," he told
The New York Times.
A clinical study reviewed by the FDA found participants could
perform basic activities like detecting the direction of a motion,
recognising large letters, words, or sentences, detecting street
curbs, walking on a sidewalk without stepping off, and matching
black, grey and white socks.
"This is a game changer... that represents a huge step forward for
the field and for these patients who were without any available
treatment options until now," said Robert Greenberg, chief
executive of Second Sight, the California-based company that
developed the Argus II.
The Argus II received approval in Europe in 2011 to treat severe
blindness from any type of outer retinal degeneration, but is only
being marketed there for RT, according to The New York Times.
In the US, more trials are needed for approval.
The Argus II will be available later this year in approximately 10
clinical centres across the US.
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