Diagnostics & Imaging Week
Early diagnosis of glaucoma is critical to delay progress of the disease. But when physicians monitor early changes in an eye, they do so by comparing separate photos, held side by side, to judge whether or not glaucoma has progressed.
After five years of work, EyeIC (Narberth, Pennsylvania) has received FDA 510(k) clearance for its first product. MatchedFlicker diagnostic software converts time-series retinal photographs into a "movie" to monitor the start and progress of glaucoma with greater accuracy.
"Currently there is no other product on the market for automated analysis of the optic nerve," CEO Ira Wallace, MD, told Diagnostics & Imaging Week. "Some of the camera packages come with tools, but none have this precise automated alignment that allows the kind of change detection that MatchedFlicker does."
He added, "Right now, when doctors examine photos they tend to have poor agreement about the changes they see. A group of expert doctors will disagree very often. They agree at rate of just 30% to 40% of the time. The current standard is a flawed standard and everyone knows that. That's the reason we developed MatchedFlicker. Early evidence shows that using this technology will help them to agree better."
The technology works by first taking retinal images from a patient during different visits. Those images are melded into a moving photo by MatchedFlicker to highlight the changes in motion.
Certain subtle features that might escape detection when doctors look at side-by-side photos, such as faint disc hemorrhages or peripapillary atrophy progression, can be spotted within seconds.
As they evaluate, eye care professionals can mark the changes on the Flicker and images. MatchedFlicker translates the doctor's marks in a Flicker project to the appropriate location on all other images in the same project. All of the images and annotations are then saved in an electronic format and can be printed if needed.
"It's a tool for examining serial retinal photographs of the optic nerve," Wallace said. "It makes the diagnostic process faster and easier."
The Glaucoma Research Foundation (San Francisco) estimates that four million Americans have glaucoma, but only half of those know they have it and it's the second leading cause of blindness in the world.
Glaucoma is actually a group of diseases that can damage an optic nerve and cause vision loss and, eventually, blindness. It starts when normal fluid pressure inside the eye increases.
The most common form of glaucoma is called open angle. A clear fluid flows in and out of the anterior chamber, leaving it at an open angle where the iris and cornea meet. For some people, that fluid starts to pass too slowly and it builds up, increasing the pressure inside the eye, ultimately damaging the optic nerve, according to the National Eye Institute (Bethesda, Maryland).
Most people have no symptoms in the early stages of glaucoma. But with time, objects to the sides start to fade out. Glaucoma can eventually cause a loss of peripheral vision. Early treatment can delay this progression. Later-stage treatment can include laser trabeculoplasty to drain the fluid or conventional surgery to make a new opening for the fluid to leave the eye.
A price has not yet been set for EyeIC's new tool for eye care professionals. Wallace said the product will be introduced to the medical community at the World Glaucoma Congress next month in Boston. Pricing for patients also is still being determined. The company has not approached insurance firms about reimbursement.
"Our rollout plan is to introduce it to doctors directly through some distributors, but first at the World Glaucoma Congress," he said, adding that doctors will be given a free, limited trial like most other software products.
MatchedFlicker is a technology that was pieced together from various sources of intellectual property. EyeIC is developing similar products for other medical fields, said Wallace, who declined to elaborate.
EyeIC currently has enough funding to launch MatchedFlicker but by the end of the year, the company, currently with five employees, will be seeking to raise more money. In November 2008, EyeIC completed a Series A round of $1.9 million from MentorTech Ventures, Ben Franklin Technology Partners, private investors and its founder.
"The company is virtual and we will hire several consultants and contractors at first, depending on how the product grows," Wallace said.
EyeIC is sponsoring research for prospective studies of retrospective data at four universities to help back up its claims of product usefulness.
"We're looking at usefulness to glaucoma experts and non-experts alike," he said.
A CE mark in Europe is expected by midsummer and MatchedFlicker will be rolled out there by 4Q09.