FDA approves Moria's Epi-K

May 15, 2005

Patients, especially those over age 40, are more educated about LASIK and often are seeking alternatives.

The arrival of Moria's Epi-K disposable epikeratome in the U.S. market may help shift the future of laser vision correction away from PRK and LASEK surface ablation procedures, predicts one ophthalmologist.

The Epi-K received FDA approval on March 30. The device also recently received a CE Mark authorizing sales in the European Community and has been approved for sale in Japan. Moria began to fill orders for the epithelial separator in late April.

The device joins three other epikeratomes that have received FDA approval-including devices by Gebauer Medizintechnik GmbH, Norwood EyeCare, and Advanced Medical Optics-but is the first such instrument to be approved on the basis of human studies, according to Don Mikes, vice president, global marketing, Moria Inc., Doylestown, PA.

Patients who undergo Epi-LASIK do not suffer the haze, pain, and slower vision recovery associated with PRK and LASEK, Mikes explained.

Although LASIK may surpass Epi-LASIK in terms of recovery time-1 or 2 days versus 3 or 4-many patients prefer the idea of a bladeless procedure. Mikes said he draws a distinction between "separating" the tissue with Epi-LASIK and "cutting" it with LASIK. He compared Epi-LASIK with the careful peeling of a label from a notebook.

"Some patients simply don't like the idea of having their eye cut," Mikes said.

Making the switch The procedure offers so many advantages over PRK and LASEK for Rick Milne, MD, that he plans to shift all of his surface ablation patients to Epi-LASIK. Dr. Milne, who practices in Columbia, SC, was one of four ophthalmologists who studied the Epi-K device for Moria.

In a practice that once performed LASIK on 95% of patients, Dr. Milne has turned to surface ablation for about one-third of his patients. He believes surface treatments have better outcomes than LASIK, pointing to better contrast sensitivity and visual acuity that result from less induced higher-order aberrations.

"We, as ophthalmologists, are going to have to be forced kicking and screaming back to the surface," Dr. Milne said. "I do a lot of LASIK and I love LASIK, but placing the increasingly advanced ablation patterns being offered by custom ablation onto a less-than-smooth stromal bed is becoming harder to rationalize."

Patients, especially those over age 40, are more educated about LASIK and often are seeking alternatives, even if there is some pain and a slightly longer recovery, he said.

In Dr. Milne's study, only one Epi-K patient had discomfort above level 5 (of 10) on day 1, and after that, no one had more than level 3. By comparison, PRK patients often had pain levels of 6 to 8 on day 1, he said.

Visual recovery was not as good as LASIK cases, but better than his PRK or LASEK patients, Dr. Milne said.

Ninety percent of his Epi-K patients were able to return to work on day 4, and most removed their bandage contact lens on day 6, compared with only about half of his PRK patients who returned to work on day 4, whereas his LASIK patients return the day after surgery. Epi-K patients averaged visual acuity of 20/40 on day 4, which Dr. Milne called adequate.

At 1 month, the average was 20/25, which was "pretty amazing, actually," he said.

Dr. Milne already owned a Moria microkeratome, so he did not try the other three epikeratomes on the market. He called the Epi-K "well thought-out" and user-friendly since the blade is self-contained.