Annual visits to an optometrist’s office aren’t usually very a high on a diabetic patient’s to-do list. In fact, of the 18 million to 20 million people with diabetes in the U.S., it is estimated that only half get annual examinations assessing retinal risk.

But assessing that particular risk is considered to be the first and foremost must-do — or else — for these people, since more than 80% of all those who have had diabetes for 15-years or more are stricken by diabetic retinopathy, a disease of the retina that eventually leads to blindness and considered a leading cause of blindness in the U.S. And more than 90 % of these cases can be eliminated with the proper screening and subsequent treatment.

The problem? — as with many physician recommendations — poor patient compliance with a referral to an ophthalmologist for this assessment.

Now, Digital Health (Wake Forest, North Carolina) has just won PMA approval — reported last week — for its Retasure software that enables even a non-clinician in an eye care facility to do the retinal risk assessment. The primary feature is its compatibility with most non-mydriatic fundus cameras to detect symptoms of diabetic retinopathy. A non-mydriatic camera provides sharp color images of the inside of the eye. The camera’s software allows for viewing of the stereo images without 3-D devices or other visual aids.

Diabetic retinopathy, which has no obvious initial symptoms, occurs when blood vessels form at the back of the eye and bleed onto the rods and cones within the eye. The longer a person has diabetes, the higher risk of the disease developing.

According to statistics nearly all patients with Type I diabetes, and more than 60% of patients with Type 2 diabetes, have some degree of retinopathy.

There are three treatments for the disease which are said to be very effective in reducing vision loss. These treatments are laser surgery, injection of tramcinolone into the eye and virectomy.

“[Diabetic] retinopathy is a disease that is in the background right now,” Marc Winchester president, North America and board director of Digital Health, told Medical Device Daily. “It’s a disease that becomes much more talked about as diabetes becomes a problem in the United States.”

Winchester said the software — as of now in only a handful of sites, including North Carolina, Texas, Ohio and Pennsylvania — is used to capture digital images of diabetic patients’ retinas in a non-invasive procedure that takes just a few minutes. These images are then transmitted through a secure HIPPA-compliant network to a board-certified ophthalmologist at an accredited reading center for examination. It is non-invasive and requires no dilation of the eye.

“The process takes seven minutes,” Winchester said. “The camera takes one picture of each eye.”

The eye care professional will look at the retina for early signs of the disease, such as leaking blood vessels, retinal swelling, such as macular edema, pale, fatty deposits on the retina (exudates) — signs of leaking blood vessels, damaged nerve tissue (neuropathy), and any changes in the blood vessels.

“Eventually we’ll have Retasure [deployed] nationwide,” Winchester asserted, with confidence. “We’re going to have a state-by-state initiative. FDA approval for Retasure technology platform marks a major step forward in the development of Digital Healthcare. Pre-market approval clears the way for the company to market our products and services more widely. ”

The software received CE mark approval in Europe in 2000.

“The U.K. mandates diabetics to go to an optometrist and be tested for this disease because of socialized healthcare,” Winchester said. “So far, more than 1.5 million patients in [Europe] have been tested through Retasure.”

However, this picture differs greatly in the U.S., Winchester said, where the risk of diabetic retinopathy is seriously under-diagnosed.

“We did two diabetes fairs in Cincinnati, and we had 70 to 74 patients screened,” he said. “Out of those patients we found 40 cases with retinopathy, ranging mild to severe. Of those, 10 were severe cases.”

Queen City Physicians of Cincinnati was one of the first to banner a contract with Digital Healthcare to provide Retasure assessments of their patients with diabetes.

“This is an exciting development for Queen City Physicians,” said Pamela Coyle-Toerner, CEO of the Queen City Physicians, in a statement. “Retasure allows us to expand the range of care to our diabetic patients and will greatly enhance our ability to discover diabetic retinopathy in a timely — and sight-saving — manner.”

Winchester says the FDA approval will launch what it is calling the start of a more aggressive distribution of its offerings and platform technology.

“The approval not only covers our retinal risk assessment products such as Retasure, but also our next-generation clinical ophthalmology technology which effectively integrates most instruments and technologies used in clinics using workflow management tools,” Winchester said in a statement. “Our reach now extends from the detection of eye disease, through diagnosis and patient outcome management.”

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