Quick Hits

EVA gains FDA nod

DORC’s vitrectomy system controls vacuum and flow

By Ashley Schreyer, Associate Editor

EVA, a vitrectomy- and phaco emulsification system for retina, and combined and cataract surgery, has obtained FDA 510(k) approval. Designed by the Dutch Ophthalmic Research Center, EVA was launched in Europe in 2013.

The system is now in more than 250 locations in Europe and has been used on more than 250,000 procedures. The launch of EVA in the United States is an important milestone in the company’s investment in the American market and an indication of its commitment to providing an innovative, economically competitive alternative in the market.

“We are very proud to announce the launch of EVA in the USA,” Ilze Timmers, CEO of DORC International, said in a news release. “This significant milestone follows closely on the heels of the EVA approval in Japan, last month. We now have our flagship next-generation Vit-Phaco machine available for sale in three of the five biggest economies in the world. Moreover, it is an exciting day for EVA, a system optimized for ophthalmic surgery, based on design input from ophthalmic surgeons around the world.”

EVA’s design houses several technologies designed for enhanced surgical control and flexibility — including the unique VTI pump system (offering both flow and vacuum fluidics), TDC (two-dimensional cutting) vitrectome with cut speeds of up to 16,000 CPM, LED illumination and AIC — active infusion compensation.

EVA has two models, anterior and combined, but only the latter is approved in the United States. The combined model includes LED illumination, viscous fluid control and air fluid exchange, among other specifications, that the anterior model does not. EVA also offers a variety of laser probes and light fibers with different gauges to suit individual needs.

“We are very excited to see that this day has finally arrived,” said Gaurav K. Shah, MD, the codirector of Retina Fellowship at The Retina Institute and professor of clinical ophthalmology at Washington University. “The EVA machine will allow both vacuum and flow options in a seamless fashion for the OR of the 21st century. American surgeons now have the option of the most technically advanced vitrectomy machine that our European counterparts have had for over a year now.”

ZEISS, ORAYA JOIN FORCES TO COMBAT WET AMD

By Jerry Helzner, Contributing Editor

Carl Zeiss Meditec and Oraya Therapeutics have entered into a collaboration agreement under which Carl Zeiss Meditec will provide funding to help grow the potential for Oraya’s radiation therapy for wet AMD over a period of up to two years. In turn, CZM will receive rights in Oraya reaching up to a majority stake after two years.

Oraya has developed and commercialized a low energy X-ray radiation therapy that is available commercially in Germany, the UK and Switzerland. The collaboration is intended to accelerate and expand these initial European market developments.

While specific terms of the agreement were not disclosed, the companies note that CZM will be making a meaningful strategic investment in Oraya, and that further opportunities to leverage the companies’ respective technical and market expertise and resources will be reviewed.

Illustrating ophthalmology’s giant leaps in rare form

AAO’s Museum of Vision is the new home to some very, very early visionaries.

By René Luthe, Senior Editor

The American Academy of Ophthalmology’s Museum of Vision enjoyed a windfall recently, acquiring some of the oldest and most influential texts ever published in ophthalmology. The Spencer E. Sherman, MD, Antique Ophthalmology Book Collection includes more than 130 rare books, catalogs and illustrations — among them the 16th century work, “Ophthalmodouleia: Das ist Augendienst,” considered the first systematic work on ocular disease and ophthalmic surgery.

“These texts represent a lasting monument to the great thinkers in ophthalmology’s past,” says Dr. Sherman, who says he spent decades building the collection.

The Museum of Vision will maintain a rotating display in its galleries at the Academy’s national headquarters in San Francisco. Here are some highlights from the collection.

From “The Human Eye,” by Securio. This image shows a “sectional model” of the eye made of paper with anatomical parts numbered for reference.

From “Descripto Anatomica Oculi Humani Iconibus Illustrata” (“Illustrated Anatomical Description of the Human Eye”) by Johann Gottfried Zinn, 1755.

From “Atlas der Ophthalmoskopie” by Johann Oeller, 1899. This image is of a retinal detachment years after a traumatic injury. The caption in Latin reads, “Amotio retinae sanata,” or, “Healed retinal detachment.”

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ALL IMAGES COURTESY OF THE AMERICAN ACADEMY OF OPHTHALMOLOGY AND MUSEUM OF VISION.

When to call a neuro specialist

Look for patterns in the process

By Chris Bahls, Executive Editor

When glaucoma specialists gathered in San Diego recently for their annual conference, members of the American Neuro-Ophthalmologist Society, convening for their own assembly, joined them for a first-time, one-day event. The program and abstract book, 260-plus pages strong, was an interesting mix of topics like optic nerve morphology as a marker for disease severity in cerebral palsy of perinatal origin (Poster 17) and one-year results of an ab-interno gelatin stent in combination with mitomycin c for the treatment of glaucoma. (Poster 45)

What seemed to be missing from the program, however, was a basic question begging a basic answer: What should an ophthalmologist look for in trying to determine if a patient needs to see a neuro-ophthalmologist?

Look for patterns in the process, says S. Khizer Khaderi, MD, MPH. Is the problem involving the afferent or efferent components of the visual system? Is the pupil responding to light, or a decrease in brightness sense? Or is there a color deficit or a problem with visual field? These would provide clues if the problem is with how visual input is being processed, and would be an afferent problem.

Dr. Khaderi, an assistant professor of neuro-ophthalmology at UC Davis in Sacramento, Calif., and director of UC Davis Eye Center’s neuro-ophthalmology service and sports vision lab, says that in terms of triaging these patients, he has a simple formula, courtesy of a former mentor:

Severity X Treatability = Urgency. If there is vision loss, determine how severe is it, and how acute is it? The ophthalmologist must also consider these questions along with the other addressed clues. With this information, an informed decision can be made.

It’s an important consideration, he says, as to whether a neuro-ophthalmologist should be consulted. “There is a lot of demand but limited supply,” he says. [Ophthalmologists] who do not see neuro-ophthalmic cases regularly can feel overwhelmed and are quick to push these patients as urgent referrals, when oftentimes they are not. Using a simple formula, similar to the aforementioned one, can help facilitate the triaging process.

“There aren’t that many of us,” says Dr. Khaderi. “There are 600 here, maybe 160 in training.” OM