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Epi-LASIK: An Evolving Procedure in a Fledgling Market
Surgeons are refining methods as manufacturers are establishing a market.
BY JOHN PARKINSON, ASSOCIATE EDITOR

The reemergence of surface ablation, especially epi-LASIK, in the refractive market has been a continuing trend in recent years. The numbers from a 2005 survey of ophthalmologists and the launch of four epi-LASIK products since 2003 serve as evidence of this growing trend.

In addition, epikeratome manufacturers and surgeons are working together to increase epi-LASIK's profile. These surgeons who have integrated epi-LASIK into their practices are starting to recognize that it can serve as an alternative to LASIK, and some see it as a replacement for other conventional surface ablation procedures.

And while epi-LASIK is an established procedure, surgeons are continuing to explore various methods of performing it and simultaneously looking for ways to position it in their practices. 

This article will look into how epi-LASIK is penetrating the refractive market today, surgeons' personal preferences in performing the procedure and the ophthalmic community's efforts to position it.

AMO's Amadeus II system with surface ablation module can perform epi-LASIK or LASIK.

The Market Today

When new products or technologies are introduced into the market, it can take considerable time before they achieve widespread market adoption. Such is the case with epi-LASIK.

Epi-LASIK accounted for only approximately 1.5% of all refractive procedures in the United States in 2005, according to David Harmon, president and senior editor of Market Scope. "The movement you see is relatively small," says Harmon when asked about epi-LASIK's place in the refractive market today.

While this is a seemingly small number, surface ablation as a whole is on the rise. Market Scope surveys ophthalmologists on a variety of refractive surgery issues, and they reported 9.6% of refractive surgeries performed in 2005 employed surface ablation techniques, which is up from a reported 7.2% in the 2004 survey. This continues a pattern of surface ablation growth over the last several years.

Most see epi-LASIK eventually grabbing a greater piece of the refractive market pie. Dave Fancher, president of CooperVision Surgical, believes consumers will demand it once they realize it offers a better quality of vision, and that it is safer than LASIK and other surface ablation treatments. "Quality of vision and safety are going to be the two key issues that will drive this," he notes.

Diane Appler, senior global marketing manager, Laser Vision Correction Group, Advanced Medical Optics (AMO), says epi-LASIK is finding a middle ground between being a niche and a large, growing market. "I think it is somewhere in the middle. It is increasing in popularity, and our market research has shown that about one third of all laser vision correction procedures in the U.S. will probably be done with a surface ablation [method] by the end of 2007."

Don Mikes, vice president, Global Marketing, Moria, says the aforementioned numbers from the Market Scope survey validate Moria's observations that there is an increasing interest in surface ablation among refractive surgeons. "We are continually monitoring trends and see a steady increase in the percentage of surface ablation procedures being performed."

While there was initially pent-up demand for epi-LASIK, performances issues with earlier versions of competitive epikeratomes, as well as "market inertia," have kept industry sales at a modest level, says Mikes. It appears that many surgeons have been waiting to hear more about epi-LASIK before investing in the technology.

Nonetheless, Mikes is confident epi-LASIK will have a prominent role in the refractive market. "I don't see it as a niche; I see it as fulfilling a significant need and that it will eventually become a major segment of the laser vision correction market," says Mikes. "The surgeons will eventually decide, but there is enough in the literature and the experience indicating that surface ablation has distinct advantages, and I believe that epi-LASIK will ultimately emerge as the preferred surface technique."

LASIK, Epi-LASIK

Moria's Epi-K has a built in applanation plate that is intended to prevent the separator from going into the stroma. The control unit also operates Moria's One Use-plus and M2 microkeratomes.

When considering the integration of epi-LASIK into their practices, some surgeons may be naturally inclined to compare it to LASIK. The conventional wisdom has been that LASIK offers faster visual recovery and less pain than surface ablation. With LASIK, patients can see quite well in 1 to 2 days post-op. Epi-LASIK cannot make that claim yet.

Surgeons who are performing epi-LASIK are making great inroads in mitigating pain, and they say the discomfort difference between epi-LASIK and LASIK might be negligible at this point. Surgeons interviewed for the story provided their pain management regimens, which will be discussed later in the article.

One area where epi-LASIK is more advantageous than LASIK today is fewer complications.

"If you are going to do refractive surgery, why not do a procedure where the complications are extraordinarily low and the outcomes are fairly predictable?" asks Lamar Chandler, vice president, Marketing, for the United States and Europe, Norwood.

Surgeons who have implemented epi-LASIK into their practices are reporting patient safety as a paramount reason for doing so.

"I'm becoming much more cautious in terms of whom I will perform any procedure on, but more importantly, whom I will perform a LASIK flap on," says Bruce Larson, M.D., principal, Larson Eye Center, Hinsdale, Ill.
Dr. Larson attributes his initial interest in epi-LASIK to his own personal experience with LASIK and suffering from halos. In fact, his wife had LASIK as well and suffers from the same problem. His personal experience, compounded by concerns about ectasia and kerataconus, has motivated him to perform more epi-LASIK.

Dr. Larson estimates about 60% of his laser vision patients still undergo LASIK, but the remaining 40% of them now undergo epi-LASIK. He has been using the EpiVision system (Gebauer/CooperVision Surgical) in his practice.

Eric Donnenfeld, M.D., partner, Ophthalmic Consultants of Long Island and Connecticut, also says patient safety has influenced him to introduce epi-LASIK into his practice. "My use of surface ablation has increased as the indications have increased, and as my concerns for complications with LASIK are increasing," says Dr. Donnenfeld.

He says the wider and deeper ablations associated with custom LASIK reduce the residual stromal beds available and create concerns about ectasia. In addition, irregular topographies, which he would have treated with LASIK years ago, are now more suited for surface ablation.

So the question remains will epi-LASIK be an alternative to LASIK or a replacement to it? Fancher thinks that while some practices may go totally over to surface ablation, most surgeons will adopt epi-LASIK to go along with their LASIK procedures. "I think most practices will offer both and it will depend on the profile of the patients as to which they'll choose," predicts Fancher. "I don't think this is a takeover; I think it is a complementary way of meeting patient needs."

Norwood's Epikeratome has a polymer separator. It was the first epi-LASIK product approved for the U.S. market.

Flap Removal

One significant area of ongoing debate in epi-LASIK has been whether or not to leave the epithelial flap. Surgeons have been reporting success with both techniques, but some say flap removal procedures outperform standard epi-LASIK.

Dr. Donnenfeld has been having success with flap removal, and he and colleagues use the term lamellar epithelial debridement (LED) to describe the technique. They began using the term when doing a comparative study with epi-LASIK and LED.

"We have evaluated LED and epi-LASIK, and we have found LED provides more rapid visual rehabilitation than epi-LASIK, while epi-LASIK is more comfortable," says Dr. Donnenfeld. He has been using the Amadeus II system with surface ablation module (AMO).

H.L. "Rick" Milne, M.D., president, The Eye Center PA, Columbia, S.C., is an Epi-K user and an advocate of removing the flap. In referring to the procedure, he uses the term first coined by Raymond Stein, M.D., Bochner Eye Institute, University of Toronto: Keratome-Assisted Advanced Surface Ablation (KAASA). 

Dr. Milne says all of his KAASA patients thus far have been fully healed and their bandage contact lenses removed by 3 days post-op. He also says this method has allowed many of his patients to go out and function the next day after surgery, and he has not had one patient who has not been able to return to work after 3 days.

Dr. Milne is now performing KAASA exclusively on his surface ablation patients after having a similar complication arise in three patients who had epi-LASIK. On these patients, there was what he described as multiple layers of epithelial growing, so it caused a refractive effect that delayed the recovery. In these patients it appears that the flap was so viable that a second layer of epithelium had grown over or under the flap. All three patients eventually resolved to corrected visual acuities in 6 weeks to 2 months.

Warren Cross, M.D., principal, Warren Cross and Associates, Houston, Texas, performs conventional epi-LASIK in most of his surface ablation patients, but he also utilizes a flap-removal technique, which he calls Epi-PRK. He says modifying his Epi-PRK over the last year and a half has led to faster visual recoveries in patients. "We are using less fluid during the surgery and lifting a dry flap," says Dr. Cross. "We actually have some of our patients 20/25, 20/30 the next day." He has observed that his Epi-PRK patients see better faster than his conventional epi-LASIK patients. He is using Norwood's Epikeratome.

Other Surface Ablation Modalities

Traditional PRK is still the number one surface ablation technique, according to Market Scope. Their survey asked surgeons about their plans for 2006. Those respondents who planned on performing surface ablation, said they expected to perform traditional PRK in 4.2% of cases, epi-LASIK in 2.7% of cases and LASEK 1.4% of the time.

While this does not appear to bode well for LASEK supporters, it does leave a question about how PRK will be performed in the future.

Dr. Larson still performs the traditional PRK method with the Amoils brush and has not used his epikeratome for the modified PRK because he sees it as too expensive.
He does concede, however, that using an epikeratome to do PRK would create "a beautiful surface."

Some surgeons take a contrary viewpoint and believe flap removal with the epikeratome will replace traditional PRK. "LED and epi-LASIK are replacing [traditional] PRK," asserts Dr. Donnenfeld. He says LED and epi-LASIK are more comfortable, reliable and faster healing procedures than traditional PRK.

Dr. Milne says KAASA outperforms LASEK and traditional PRK. "It [KAASA] brings a very quick epithelial re-covering of the stromal bed, much quicker than you get with other methods such as alcohol or with a brush," states Dr. Milne. "The key here is the epithelial cells right next to where they have been lifted, are completely untraumatized, so they heal very quickly and without a leading edge of devitalized cells. None of these patients have had a central dendritic accumulation of these devitalized cells as you can sometimes see in PRK or LASEK."

Haze and Pain Management

The EpiVision system was developed by the German company Gebauer Medizintechnik. CooperVision Surgical acquired the rights to sell the system.

Haze had initially been an issue for surface ablation patients, but doctors are including mitomycin C in their regimens to alleviate this complication. For all of his surface ablation patients who are more than -6 D or their ablation is over 75 microns, Dr. Donnenfeld has been using mitomycin C 0.02% for 10 seconds intraoperatively.

"I want to minimize the risk of haze, and by using mitomycin I can almost eliminate it," explains Dr. Donnenfeld.

Dr. Milne also utilizes mitomycin C. "If I have an ablation depth of over 75 microns, I use mitomycin C for somewhere between 20 to 30 seconds, and with that [regimen] I have not had haze [with any of his KAASA patients]," reports Dr. Milne.

While surgeons vary in their pharmacological regimens to mitigate pain, one common routine for all has been to use chilled or frozen balanced salt solution (BSS) or tears. The surgeons interviewed for the story offered their pain management pharmacological regimen.

Dr. Larson makes the distinction to use 40 to 50 drops of partially frozen BSS immediately before the epikeratome pass and not afterwards like many other surgeons do.

"We have seen a dramatic reduction in postoperative pain," says Dr. Larson. He also gives patients 40 mg of prednisone 45 minutes preoperatively.

Dr. Donnenfeld has his patients use chilled tears. He uses Acular LS (ketorolac tromethamine, Allergan) QID starting the day before the surgery. Post-op, he soaks the contact bandage lens in Acular PF. Dr. Donnenfeld also writes a prescription for Vicodin (hydrocodone, Abbott Laboratories), which he says patients rarely ever use.

Dr. Milne freezes the cornea after laser treatment with a frozen Weck-Cel sponge. He also uses Xibrom (bromfenac ophthalmic solution, ISTA Pharmaceuticals) BID, Pred Forte (prednisolone acetate, Allergan) and one of the fluoroquinolones QID.

On the morning of surgery, Dr. Milne initiates Neurontin 300 mg (gabapentin, Pfizer) TID for 3 days. "It is an analgesic drug that has mild sedative properties. It really mutes nerve-ending pain used to treat post-herpetic neuralgia." He writes a prescription for a stronger pain medication, but he advises patients not to get the prescription filled unless they get what he calls "breakthrough pain."Dr. Milne reports that less than 5% of patients need the additional medication.

Dr. Cross starts patients on systemic anti-inflammatories pre-op. He prescribes Celebrex (celecoxib, Pfizer) 200mg p.o. q.d. starting 3 days prior to surgery and continues
3 days post-op. For patients who may not want to take Celebrex, Dr. Cross will suggest Motrin (ibuprofen) TID 3 days pre-op and then 4 days post-op. He also uses Acular PF BID or QID 3 days pre-op.

He uses a Weck-Cel sponge with frozen BSS on the cornea for 1 minute after ablation. This "frozen popsicle" has really alleviated patient pain according to Dr. Cross. Post-op, he will rotate Pred Forte, Acular, and Zymar (gatifloxacin, Allergan).

Getting the Word Out

The consultation between a surgeon and potential patient is paramount. Epikeratome manufacturers, and vendors are aiding surgeons in understanding the technology so they can in turn discuss the merits of epi-LASIK with their patients.

However, Appler makes the distinction that it is important for surgeons not to overwhelm patients with technological talk, but rather to point out the advantages of the procedure.

"We don't really want them to overhype the technology to the patients, that's only confusing," explains Appler. She says some patients might have contraindications to undergoing LASIK, and therefore, might be natural candidates for epi-LASIK.

During his initial consultation with potential surface ablation patients, Dr. Donnenfeld will tell them about the different options that are available to them. He says the most important part of the consultation hinges on the response to one question.

'"Are you interested in seeing as well as you can as fast as you can or are you more interested in having more comfort postoperatively?"' asks Dr. Donnenfeld. "Most patients feel they would like to be visually rehabilitated as soon as possible."

Because more people want a faster recovery, Dr. Donnenfeld is mostly doing LED procedures and only occasionally doing conventional epi-LASIK procedures for his surface ablation patients. He can get LED patients back to work in approximately 4 to 5 days.

Mikes sees another opportunity during the consultation to discuss epi-LASIK with patients who are reluctant to undergo LASIK.

"LASIK has been a very successful procedure, but the [market] penetration is still quite low. We think there are a lot of people on the sidelines who simply are fearful of having their eyes cut," says Mikes. "If surgeons can say, 'here is an alternative procedure in which we are basically pushing back that very thin outer layer that subsequently grows back,' then they have the ability to attract new patients into the marketplace."

Interestingly, some doctors are already seeing potential epi-LASIK patients seek them out to discuss the procedure because of their advertising and their presence on the Internet. Dr. Cross has a billboard in Houston and advertises in local newspapers and TV. He says many people who seek him out for epi-LASIK consults are generally well educated and risk averse.

Ana Vasquez, refractive coordinator for Dr. Cross adds, "they know there are going to be no cuts on their corneas and that there is less pain than[traditional] PRK."

Dr. Larson is also being sought out by people to discuss epi-LASIK. As he was the first surgeon to perform epi-LASIK in the state of Illinois, a local news station and newspaper covered the event. He not only was able to garner new patients because of the initial media coverage, but the media outlets put their stories on their Web sites. Potential patients can do a Web search on the subject and find Dr. Larson's practice.

Dr. Larson has also begun a direct marketing campaign. "We are doing a direct mailing on the difference between LASIK and epi-LASIK, and basically positioning epi-LASIK as a safer alternative." With his office in suburban Chicago, Dr. Larson says the local market is saturated with LASIK advertising, and he wants to differentiate his practice from other refractive surgeons in the area by offering epi-LASIK.

Epithelial Healing

Chandler believes if epi-LASIK is going to close the recovery time gap with LASIK, quicker epithelial healing will be key.

"I think there is work to be done in terms of getting the epithelium to heal much faster than right now," explains Chandler. He believes in order to quicken healing, pharmaceutical agents will need to be developed.

Dr. Larson concurs and says that preserving epithelial cells, as opposed to letting them die off, could be epi-LASIK's equalizer with LASIK. "If we can reduce the number of cells that go through apoptosis, we can speed up visual recovery."

The refractive market overall is experiencing a renaissance with a growing number of newer procedures to serve a large group of potential patients, and epi-LASIK is one very good example. While no one at this point can accurately predict where epi-LASIK will eventually land in the refractive market, many surgeons agree it can be fully utilized in today's practice.