Q: How has the worldwide economic downturn affected LASIK surgery rates globally?
A: Obviously, the worldwide economic downturn has affected LASIK. What nongovernment-reimbursed procedure has not been affected? Aesthetic products, such as those offered by Allergan, Inc. (Irvine, California), for example, have obviously been affected as well. Even procedures, such as hip replacements, where the patient has a significant copay amount, have been affected. I don't think anybody could have predicted the severity and range of the recession we are seeing today.

Despite the downturn in the economy, the good news for Advanced Medical Optics, Inc. (Santa Ana, California) is that we continue to drive our share of the global market. We do that because we are still the world market leader in refractive surgery. With the incorporation of the IntraLase FS Laser along with our Star S4 IR Excimer Laser platform, we have the only combination of a femtosecond laser with the highest level of custom excimer ablation. Our position with both independent and chain centers in the United States continues to grow.

Outside the United States, it has been our policy for the past several years to continue to expand our presence across the globe, and we have done that. So even with the economic downturn being felt in Europe and parts of the Asia-Pacific market, we have continued to increase overall use of our product lines.

In Japan specifically, the ophthalmic market has not seen the downturn that it has seen in other regions. There seem to be several reasons for this. First, LASIK delivery is concentrated in chains rather than private practices. In markets with many separate outlets for LASIK, as in the United States, there will be a bell-curve reaction in tough economic times: A few practices will flourish, most will be somewhat affected, and a small minority will not survive. But when delivery is concentrated in a few outlets, they are better able to manage tough times. Second, the Japanese population is highly myopic, so there is a greater geographic concentration of potential patients or customers for LASIK than in most other markets. Third, they have done an effective job of marketing the procedure. They have targeted generation Y, the children of the baby boomers. In the United States or Europe, LASIK practices attract more baby boomers, but in Japan they tend to have younger patients because that is who they have targeted.

Q: You mentioned differences in the generations. Can you talk about each generation—their attitudes toward LASIK, how they are being affected by the economic situation, and the effects each feel from the credit crunch?
A: Generation Y, generally people aged in their late 20s and into their 30s, is a promising market segment for LASIK. We are beginning to try to target them in the United States and Europe, as Japan has successfully done. We believe they will have a stronger affinity for LASIK than older generations for several reasons. First, their parents had it, so it is more of a familiar, common therapy. I'm a baby boomer, and both my wife and I have had LASIK, so it is not a foreign concept to our children. Because it is familiar to them, they will be more receptive to it. Second, generation Y tends to be influenced not so much by traditional media, such as television or newspapers; they tend to be more influenced through the Internet, more viral-oriented, more receptive to the experiences and recommendations of their peers. They spend a lot of their energies on referrals, and referrals are the No. 1 reason that people have LASIK.

Now, one might think: These are young people, so their income is not at a level to support refractive surgery; however, many in generation Y are living at home longer. The baby boomers didn't live at home. When we graduated from college, our first desire was to get away from home. For generation Y, their first desire is to stay home. Generation Y is generally more willing to spend money on brands—on things that they think will affect their lives and lifestyles. Also, they are getting married later in life than baby boomers did. As a result, they manage their expenses differently—not having to worry about a house payment and things of that nature. This is a group that we believe will help regenerate the LASIK market in and outside the United States.

Of course, like everyone else currently, generation Y is affected by the economic downturn and the credit crunch—perhaps more so than older generations because they are still relatively low on the pay scale. Many are still paying on student loans or looking for a job. In fact, now that jobs are scarce, many are going back to school, and they have to find the resources to pay for it. However, when the economy comes back, they are the audience that will help resurrect the LASIK market more so than the baby boomers. They will be the drivers.

Q: What about generation X—people already aged in their 40s?
A: Generation X is a huge audience for refractive surgery. The question is, will the procedure of choice for them be LASIK, or will it be refractive IOLs? Generation X is probably the first generation that is starting to look seriously at refractive IOLs.

In Europe, our multifocal IOLs are indicated for refractive lens exchange (RLE), and our directions for use contain language reflecting this. Latin American countries also receive these products with the European RLE indication statement. We do not have the same indication for multifocal IOLs in the United States, so RLE is considered an off-label use, at the discretion of the surgeon. Advanced Medical Optics, Inc., does not promote its multifocal IOLs for RLE in the United States.

There are basically four models of refractive IOL available in the United States: our two multifocal models, the ReZoom and Tecnis Multifocal; the multifocal AcrySof Restor (Alcon Laboratories, Inc., Fort Worth, Texas); and the accommodating Eyeonics Crystalens (Bausch & Lomb, Rochester, New York). These technologies are available now, and physicians have several years of experience with them at this point. More accommodating IOLs will also be entering the market in the future. There are several IOLs to choose from for RLE.

Many people in generation Y are interested in getting away from spectacles. Their active lifestyles are inhibited by spectacles, their physical appearance is inhibited by spectacles, and they are looking for an alternative. They may come into an ophthalmic practice seeking LASIK, but they might be on that outer edge where the surgeon can educate them that a refractive IOL may be better suited for them. Again, we do not promote these products for that indication, but the recommendation is in the doctor's hands.

Q: Moving on to the baby boomers, because they are already well into the presbyopic stage of life, are they beyond the range of monofocal LASIK now?
A: I would not say they are absolutely beyond LASIK, but because that group is now getting closer to developing cataracts, the refractive IOL technologies may be more appropriate for them. The desire to be spectacle independent, which is really the desire behind LASIK, can now also be treated with refractive IOLs, so they have a choice.

Patients in the lower age bracket of baby boomers probably still are attracted to LASIK, but toward the older end of that group—those now in their 60s—refractive IOLs are an option, and that is what many of them are choosing.

These patients are also more likely to have been involved with an ophthalmology practice because of eye disease or other reasons, unlike the generation Y patient who generally has not had an ophthalmologist and is more likely to come to refractive surgery through optometry. The younger patient is therefore more linked to the LASIK end of the refractive surgery spectrum, and the older patient is perhaps more inclined to the exchange of a cataract or a clear natural lens.

Q: What about presby-LASIK? Can that potentially be widely used in a presbyopic population?
A: Presby-LASIK is still in its infancy. Studies in Europe and elsewhere have shown that the procedure can have a positive effect. The question is not whether it is effective, but what is its effective range—what is the size of the effect? If it benefits only a small percentage of patients, presby-LASIK will probably stay a niche offering; however, if it can help a larger percentage, more people will gravitate to it.

My belief is that presby-LASIK will be more beneficial for the hyperopic presbyopic patient than for the myopic presbyope. Because we are leaders in presby-LASIK technology, we are making sure we do a slow walk in determining what type and how big a refractive error it can fix. We want to be sure to learn as we progress.

Q: In the future, will LASIK be offered in a two-tiered strategy—customized and noncustomized, with two-tiered pricing—or has technology now reached the point where all LASIK should be customized?
A: Currently, National Aeronautics and Space Administration (NASA) astronauts and US Air Force fighter pilots use only custom LASIK with IntraLase flap creation. To me, there is no better answer to your question than that. The US military has done a tremendous amount of research; we would not have gotten approval from NASA without it. With the rigorous physical conditions these young men and women are subjected to, both organizations picked these technologies.

Standard LASIK is not bad science. Before we had custom technology, people were happy with standard LASIK. We still sell standard cards for our lasers. But standard is not as precise as custom. My recommendation to friends and family is: Pick the right physician and choose custom LASIK with IntraLase flap creation. If you are going to have LASIK, which is a tremendous medium to reduce dependence on glasses or contact lenses, if that is your desire, why would you not want the best? The custom approach has been shown to be the best.

Q: What can the current economic crisis teach us about how to sustain refractive surgery volume in tough times? Are there ways practices can smooth the curve between boom and bust cycles?
A: We should always learn lessons from tough times. But even in the current severe crisis, the decline in LASIK volume is not entirely related to the economy. There are three principal reasons people choose not to have LASIK. In order of importance, they are (1) fear, (2) awareness—not awareness of the existence of LASIK, but awareness that they are a candidate—and (3) cost. In the current crisis, I am sure that cost has risen in priority in that list, and it could currently be the No. 1 reason, but fear and awareness are still significant factors in people's decisions.

Some practices have done a tremendous job of communicating to patients why LASIK may be the right medium for them; others have not. The industry as a whole does not do a good job in this regard. Consider cosmetic surgeons as an example of those who effectively communicate with patients. Rarely do you see cosmetic surgeons advertise price, and rarely do you see them advertise that you should come see them because other surgeons are not technically as sound. Doing that creates fear. If you tell me that the guy down the street is no good, how do I know that is true? More important, how do I know you are good? That type of message puts fear in people, not confidence.

The learning here is that we cannot blame all of the loss of LASIK volume on the economy. There is still a low penetration of LASIK among available candidates. It is thought that we have treated only approximately 2% to 3% of the eligible patients in the United States with refractive surgery. Why is that? It is because we have not been able to clearly communicate to resolve patients' fear and awareness issues.

Fear can be resolved. Your patient should know he is in the hands of the right physician; that is message No. 1. Your physician has the best available LASIK technology, with documented scientific evidence of safety and efficacy in millions of patients treated. The awareness issue arises when people have been told previously that they are not candidates for LASIK. They have astigmatism or another condition that was a contraindication 5 or 10 years ago but is not today. Leaps in technology since the last time they saw a surgeon have now allowed them to be considered for surgery. This message must be communicated to overcome the patient's lack of awareness.

In individual practices and in the industry in general, we must get better at educating the consumer on why this may be the right medium for him. We cannot just assume patients are not coming in because of the cost. Even in these tough economic times, I have yet to see an ad for breast augmentation that lists a bargain price. Cosmetic surgeons are facing the same dilemmas as refractive surgeons, but they are still marketing the same message: If you want to have this enhancement, the technology is here for you; come see me. That is the best way to market this type of service.

The other learning, which is difficult to hear in these times, is that you cannot completely cut your marketing. You must modify or improve your marketing if necessary, but you must not eliminate it. With no marketing, you are doing nothing to overcome the fear and awareness issues. There are other areas to trim—perhaps staff reductions or better managing of expenses—but marketing is the life-blood of the refractive practice.

We all know the market will come back. The surgeons who have continued to market their practices, kept their patient base flowing, and kept educating prospective patients will be the ones who will reap the rewards when the people come back.

One potential group of candidates for LASIK that is not currently being targeted by most practices is contact lens dropouts. Contact lenses are a wonderful medium for our business, and they are an excellent way for many patients to get away from spectacles. However, we know that almost on a one-to-one basis in most major markets, every time a new patient comes to contact lenses, another patient is dropping out. But we also know that many LASIK patients have previously worn contact lenses. I don't see many practices targeting these people. They are a natural audience for LASIK because they are motivated, they don't want to wear glasses, and they have demonstrated willingness to spend money on contact lenses and lens care. This is an untapped market that practices should be going after.

Q: Do you think current LASIK technology needs improvement, and if so what is needed?
A: I hope I always answer that question with a yes, because no would mean we have stopped innovating. We will always continue to innovate. We have to get better because our competition is good.

To borrow a concept from the latest book by business author and lecturer Jim Collins,¹ innovations should aim to move our product from good to great. Modern LASIK, in most instances, has good or great outcomes. We want to move more patients from good to great because those with a great outcome are the best source of referrals, and referrals are the No. 1 way to drive LASIK. People with a great outcome are the ones who will tell 10 friends how great their experience was.

An example of moving from good to great was when we introduced the innovation of iris registration, compensating for the patient's cyclorotation when moving from vertical to horizontal positioning. This changed the landscape of success for LASIK. That slight movement of the eye, which could cause a customized LASIK treatment to be slightly off-axis, could be the difference between a great outcome and a good outcome—the difference between a person testifying that Dr. Jones is the greatest thing since sliced bread, which increases referrals, versus the person who says, "It was good."

The next big change from us is a technology we are introducing this year in Europe and next year in the United States, the iDesign diagnostic system from Wavefront Sciences (acquired by Advanced Medical Optics, Inc.). To capture a scan of a patient's eye with today's WaveScan, it takes about three tries to get that topography correct. With the iDesign, the capture is achieved on the first try. This is good for streamlining your practice because you can move that patient through more quickly. Additionally, the iDesign will enhance the accuracy of the scan. So again, this will help to move the LASIK experience from good to great.

And of course femtosecond laser technology will continue to improve. We just introduced the fifth-generation IntraLase femtosecond laser technology, with enhanced speed and overall outcomes.

I see many more improvements in LASIK technologies coming over the next several years and beyond. We also want to improve the overall capability of the practitioner to use the laser, introducing easier methods for him to operate the unit. This will continue to evolve.

Q: Will LASIK remain the principal form of refractive surgery in coming years? Is there any technology or technique poised to displace it?
A: I don't think anything will displace or replace LASIK, but other technologies will complement it. Our opportunities in the future will be to increase the penetration of LASIK and to add refractive IOLs, another tremendous medium, to the list of options for refractive surgery.

Q: There was a resurgence of interest in surface ablation a few years ago. Will intrastromal ablation remain the most common approach, as opposed to surface?
A: With continued improvement in femtosecond laser technology, I think we are going to see more intrastromal activity. Interest in surface ablation has actually decreased recently because of the ability to create thinner, more consistent flaps and decrease the amount of post-LASIK dry eye with femtosecond technology.

The possibility of post-LASIK dry eye was another reason potential patients cited as a concern about undergoing LASIK. Now, that has been reduced. Femtosecond laser produces a cleaner cut than a blade, with less degradation of the surface. There is still a need for caution in people with thin corneas, but the standard deviation is lower with IntraLase flap creation than with a blade. Additionally, the femtosecond laser can be used to create pockets in the cornea, potentially for inlays, and to perform therapeutic lamellar and penetrating keratoplasty procedures.

Q: To sum up, the market for refractive surgery in general, LASIK in particular, will return?
A: I think inevitably the use of alternatives to spectacles is going to grow. As a population, we're getting older, and as we get older, degradation of eyesight is a major blow to our quality of life. To paraphrase Benjamin Franklin, "In this world, nothing is certain but death, taxes, and presbyopia."

Although in the past perhaps a 70-year-old might have been happy to be at home, today's 70-year-olds are more active—running marathons, running companies. They don't want to be spectacle dependent and have 10 pairs of reading glasses lying around the house. Improvements in LASIK, in refractive IOLs, and even in monofocal IOLs, are going to continue to be dramatic, and the reliance on spectacles will be reduced.

James V. Mazzo is the Chairman and CEO of Advanced Medical Optics, Inc. Mr. Mazzo may be reached at e-mail: jim.mazzo@amo-inc.com.

1. Collins J. Good to Great and the Social Sectors. New York, New York; HarperCollins; 2005

* Editor's Note: This commentary is the first in a series of industry interviews that will be featured in CRST Europe.