MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Enfant test measures children’s
brain response to visual stimuli
By OMAR FORD
Medical Device Daily Staff Writer
Vision impairment is an ailment that can go undetected
in a child. Their suffering is quiet. The symptoms are hardly
noticeable and the infant often is not in a position to let
the parent know what’s happening until it’s too late.
A test developed by Diopsys (Pine Brook, New Jersey),
a small med-tech company, known for providing visual
technology for patients, is giving parents a better tool for
determining if their children suffer from vision impairment.
The Enfant Pediatric Visual Evoked Potential
Technology (VEP) vision testing system is non-invasive and
is geared toward children who are six months of age and
older, in order to detect visual deficits such as strabismus,
optic nerve disorders, and severe refractive errors, which
could lead to amblyopia.
Amblyopia, or “lazy eye,” is the loss of one eye’s ability
to see details. It is the most common cause of vision problems
in children.
“The big problem is that of the 200,000 children each
year that suffer from amblyopia, only 4% are picked up in
time,” Don Lepone, executive VP/COO of Diopsys told
Medical Device Daily. “If you catch the fact that the child has
amblyopia early then you can fix it, if you catch it late then
you can’t fix it at all.”
Most tests look at the eye to determine if there’s a problem,
but in many cases the visual look of the eye isn’t the
telling feature behind the problem. What is, according to
Lepone and Diopsys is the way the image is relayed to the
brain. This theory serves as the basis behind the company’s
technology.
The test has three sensory pads placed on the patient’s
head, while an operator begins the test. Cartoon characters
appear and music plays while a series of lines stimuli are
presented to the child on a video display. The device then
measures the health of the circuitry of the nerves, those
visual pathways that send signals to the brain.
The vision test does not require dilation or sedation,
and is a painless, safe test. The Enfant is the only objective
vision testing device capable of evaluating the entire visual
pathway available today. Most insurance plans will pay
for Enfant, which takes a total of five minutes for the
patient to complete.
“So what we do is stimulate each eye and compare the
electrical energy through an algorithm,” Lepone said.
At the end of each test, a pass or fail result is shown on
the operator screen in both graphic and numeric formats. The
results are then printed out for the patient’s medical record.
The Visual Evoked Potential Technology (VEP) behind
the Enfant was originally developed in 1983 by the
Rockefeller University Laboratory of Biophysics
(New York).
This technology was licensed to NeuroScientific,
which in 1986 merged with Neurotech, a small publicly
traded company.
At Neurotech, the VEP technology was updated and
enhanced. The first systems created were the Venus and
the Enfant. Both systems were sold worldwide to large
research institutions, teaching universities, and large clinical
practices. Many of these systems remain in use today.
Diopsys acquired the rights to the VEP technology in 1998.
Upon completing additional engineering work, a new
prototype of the Enfant was developed, making it a functionally
enhanced, easy-to-use version of the original systems.
In 2002, Phase IV clinical trials, conducted by leading
pediatric ophthalmologists, were completed at five leading
eye care medical centers.
After extensive on-site testing in 2003, the Enfant was
officially launched at the October 2004 annual meeting of
the American Academy of Pediatrics (Elk Grove Village,
Illinois).
The Enfant pediatric vision testing system is now available
for pediatric practices nationwide.
To date there are nearly 350 Enfant tests out in the
states and the company expands on that number on a daily
basis. It has been a slow but successful burn – as the company
received FDA approval for Enfant back in February of
2003. The reason is an initial lack of funding to support
marketing for the device.
But plans call for the company to work on releasing a
new test also based on the VEP technology.
The Diopysis Nova–Transient Response test, or the
Nova-TR is being evaluated in Virgina and is being used to
test soldiers who have been injured in Afghanistan or Iraq
by Improvised Explosive Devices. The Nova-TR System also
evaluates a patient’s response to an external stimulus
along the entire visual pathway from the lens of the eye to
the visual cortex of the brain. By using VEP, the Nova-TR is
able to identify optical/neural abnormalities related to
vision that an Optometrist might not otherwise be able to
detect. The Nova-TR allows the clinician to objectively document
response to therapy.
“Some of these [troops] have suffered from concussions
that are so severe that the brain ends up being traumatized,”
he said. “This test will determine what if any problems they
could have with their vision as a result of this.”
Lepone said that the ball is rolling to bring more exposure
to Diopsys’ products in the future and that now it is in
a better marketing position to accomplish this goal.
“We’re a relatively small company and this has been a
six or seven year product development path,” Lepone said.
“But when you don’t have a lot of money you boot strap
your company along and prove your technology. Now we’re
in a position where we’re cash flow positive and we can get
behind some [stronger marketing efforts].”
(This story originally appeared in the Aug. 31, 2009, edition
of Medical Device Daily)
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