Medical Device Daily

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]."

Omar Ford, 404-262-5546; omar.ford@ahcmedia.com