BBI Contributing Editor

Over the past two years, LASEK (laser sub-epithelial keratomileuisis) has gained some recognition as a viable new revenue stream in the highly competitive refractive surgery market. But many industry observers predict this relatively new procedure (whereby an epithelial flap is created) will remain a niche form of refractive surgery compared to LASIK.

"LASIK is obviously a highly successful procedure," said Liz Davila, CEO of Visx (Santa Clara, California). "From both the physician's and the patient's viewpoint, the reasons are well known. LASIK is associated with minimal pain, if any, and offers immediate visual recovery. Often, the patient is able to return to his routine the next day." In addition, the physician may only need to examine the patient the first day after surgery, other than for regular checkups. Overall, "LASIK is a very patient-friendly and doctor-friendly procedure," Davila commented.

On the other hand, LASEK has certain potential clinical benefits that are different from LASIK. For example, in patients with thin corneas or the need for a high correction (meaning a deeper ablation), starting at the epithelium minimizes the concern over corneal thickness. "You have that extra depth for ablation because you are starting at the surface rather than beginning under the stromal flap," Davila said. In addition, "Bowman's membrane under the epithelium provides a nice surface for doing an ablation. This membrane is very smooth."

However, one of the downsides of LASEK is the pain factor, Davila noted. "In some cases, the pain is not much less than with photorefractive keratectomy (PRK)." More followup visits early on also are usually required. "This can be an inconvenience for both the patient and physician,"she said. There is also a slower visual recovery with LASEK.

"Clinicians will be looking at those trade-offs, and on a patient-by-patient basis, evaluating which procedure will be better for a particular patient," Davila predicted. "At this point in time, without some other technological development, I would be surprised to see LASEK reach 10% of refractive procedures." LASEK currently represents between 1% and 3% of the market.

Visx does not promote one procedure over the other. "We leave that completely to the discretion of the doctor," Davila said. "It is a patient/doctor decision. But both LASIK and LASEK can deliver excellent clinical results, and therefore I think it is good that both are available."

Stephen Joffe, chairman and CEO of LCA-Vision (Cincinnati, Ohio), said that LASEK is "complementary and additive" to LASIK. "It's being performed primarily in patients who currently are not relative or absolute candidates for LASIK. These patients mainly have too large of a pupil or too thin of a cornea. Therefore cutting a traditional flap is not advised."

LCA-Vision owns and operates 31 LasikPlus laser vision correction facilities in the U.S. and performs more than 65,000 procedures a year. However, LASEK comprises "less than 3% of volume," Joffe said. "We've been offering the procedure for over one year now." He said he expects that the low LASEK percentage will rise slightly before reaching a plateau. "LASEK will remain as a niche procedure," he said. "The majority of our surgeons don't like performing LASEK in patients who have greater than -4 diopters of myopia."

Joffe believes that LASIK will remain king of the mountain. "The results are staggering," he said. "Virtually 100% of our patients achieve 20/40, and over 90% are 20/20." Comparable results have been seen with LASEK in patients with no greater than -4 diopters of myopia. However, with LASEK, "healing is slower as with PRK," he said. "LASEK patients don't have the dramatic immediate effect as with LASIK, but within a few weeks the results are identical."

Because of LASEK, LCA-Vision has been able to expand its patient base. "These are patients we would not have treated in the past," Joffe said. Likewise, "PRK represents less than 1% of volume for us, and it has been like that for a long period of time." Overall, he said, "LASEK is one more tool in the toolbox."

There also are a number of patients who are intrigued by LASEK being a bladeless procedure. "Many patients are really scared about undergoing LASIK because they hear about the blade used to make the flap," Joffe said. If the fear factor of LASIK is effectively and aggressively promoted, there could be an additional group of patients favoring LASEK.

Nonetheless, "LASIK has been an easy procedure to sell because it doesn't hurt very much and vision is quickly restored," said Daniel Durrie, MD, director of refractive surgery at the Hunkeler Eye Institute in the Kansas City area. In contrast, "LASEK is associated with slower visual recovery and more discomfort. From a marketing standpoint, these are definitely two hurdles."

Still, there are advantages to surface ablation. "It is a safer procedure than LASIK because it does not cut the cornea," Durrie said. Furthermore, because LASEK does not cut across the corneal nerves, "the temporary dry eyes in surface ablation lasts a shorter period of time and is not as severe as in LASIK. Data is also starting to show that there is slightly less induced higher-order aberrations with LASEK, resulting in higher-quality night vision."

When Durrie presents both the pros and cons of each procedure, patients are about evenly split over which one they choose. "This is the same speech that I gave five years ago," he said. "At that point in time, 98% of my patients signed up for LASIK. But now it is 50/50." A recent European survey found that 22% of refractive procedures involve surface ablation (including PRK). "So LASEK is growing," Durrie said. "But flap LASIK also is not standing still. We are now doing IntraLASEK. Popularity should switch back and forth as the technology develops."

Although LASIK and LASEK are comparably priced, "there are practitioners who perform 100% surface ablation simply because it is safer and that is what they tell their patients they should have," Durrie said.

However, LASEK is "a more complicated procedure than LASIK," said Stephen Kilmer, director of corporate communications at TLC Vision (Toronto, Ontario). Moreover, "some individual practitioners have promoted LASEK as a new advancement over LASIK. In the crowded provider market, everyone is looking for some kind of distinguishing advantage." Kilmer frowns upon such misleading advertising and said it does not occur within TLC Vision.

The company, which has 128 fixed refractive centers and more than 300 mobile access sites, performs nearly 200,000 procedures a year. "I would estimate LASEK makes up less than 1% of volume," Kilmer said. Conversely, LASIK represents more than 95%. "There has not been a shift from LASIK to LASEK," he said. In addition, "the difference between LASIK and PRK is in comfort, convenience and healing time. There is also the 'wow' factor with LASIK."

Kilmer expects LASEK to remain a "niche, specialized technique." And even though the procedure requires some specialized training, "I think all doctors want to be well-versed in every technique, so I don't believe the training is an issue."

By contrast, he said he can easily imagine customized corneal ablation giving LASIK a run for its money in the refractive market within the next two years. "Custom ablation is arguably a different procedure," he said.