Custom LASIK: How Big Will It Get?
Surgeons report that the percentage of patients choosing this option is exceeding expectations.
BY JERRY HELZNER, SENIOR ASSOCIATE EDITOR
When the International Society of Refractive Surgery (ISRS) conducted its sixth annual "Trends in Refractive Surgery" survey in September of 2002, the long-awaited U.S. introduction of wavefront-guided custom LASIK was on the verge of becoming a reality.
Yet, even then, with the approval of Alcon's LADARVision system just weeks away, an overwhelming majority of the refractive surgeons who responded to the survey held lukewarm views regarding the potential impact of custom procedures. Fully 43% of the respondents said the ability to offer custom treatments would add little or no real value to their refractive practices, while 48% saw custom adding moderate value. Only 10% of the surgeons who answered the survey foresaw custom procedures as having the potential to add dramatic value to their refractive business.
But what a difference a year makes.
Rethinking the Impact of Custom LASIK
Recently, Ophthalmology Management talked to refractive surgeons who've been performing custom procedures, refractive practice consultants, and representatives of Alcon and VISX, the two companies whose systems have been approved for custom procedures in the United States. What we found makes a strong case that the majority of last year's ISRS respondents may have underestimated the potential market for custom LASIK. We also found that you must position and market custom procedures properly to realize the full profit potential of what many surgeons are calling a truly superior form of vision correction.
In this article, I'll explain why many surgeons are becoming enthusiastic about rejuvenating their refractive practices with custom LASIK, as they become more comfortable with using and marketing the technology.
Climbing the Learning Curve
In Canada, where refractive surgeons have been able to perform custom LASIK procedures on myopes for several years, Gordon Balazsi, M.D., whose office is located in an upscale area of Montreal, has now positioned his refractive practice as what he calls "a 100% custom clinic." He's recommending custom treatment to every patient who qualifies for the procedure.
But that wasn't always the case. When Ophthalmology Management interviewed Dr. Balazsi early this year, he was very enthusiastic about custom treatment and performing a high percentage of custom procedures, but still hadn't made the move to become a custom clinic.
"I've been doing custom procedures for almost 3 years and it took awhile to obtain enough post-op results to truly gain confidence in the technology," he notes. "The clinical data is excellent, especially in such areas as improved contrast sensitivity. My own patients' results with custom are better across the board. We're giving patients better night vision and seeing far less induced post-op aberrations as compared to standard techniques. Based on the quality of vision I'm getting with custom vs. conventional LASIK, I believe I should be doing the best procedure for our patients."
Dr. Balazsi says he and his staff are quite comfortable in operating a high-end custom clinic because they have a strong belief that custom is the best procedure for everyone who qualifies for it. The practice's television ads reflect that approach, emphasizing the use of advanced wavefront technology to achieve individualized vision correction.
"We don't talk about price," he says. "The worst thing you can do is to first talk to the patient about conventional LASIK and then switch the subject to the advantages of custom LASIK for a higher price. If you do that, you'll get a 'bait-and-switch' reputation and patients are likely to go elsewhere."
To Dr. Balazsi, the difference between conventional and custom treatment is like the difference between buying a suit off the rack or having one custom-made by an expert tailor. He says there's no comparison in terms of quality.
"Custom procedures will become the standard of care," he asserts.
Surgeons Become Believers
In the United States, Robert Beitman, M.D., of the Beitman Laser Eye Institute, West Bloomfield, Mich., prepared for the introduction of custom procedures by using a two-step approach.
Last year, Dr. Beitman began using the IntraLase femtosecond laser for creating all patients' LASIK flaps. He used his substantial advertising budget to herald IntraLase as offering a safer, more precise, all-laser method of performing LASIK and saw his procedure volume grow. He also raised his procedure fee by $300 an eye.
"We were very encouraged by the response to IntraLase," says Dr. Beitman. "We knew custom would be coming along next, so we got ready for it months in advance by upgrading our equipment, preparing our marketing campaign, and by me taking the VISX course in performing custom procedures. We were ready to go in May when the VISX CustomVue system was approved."
Dr. Beitman, who raised his fee another $300 for custom procedures, says he now recommends custom treatment for everyone who qualifies for it, and he even makes a note on the patient's chart if the patient chooses conventional LASIK over custom.
"Custom is definitely superior to traditional LASIK," says Dr. Beitman. "I want a record that a patient refused custom treatment. I don't want someone coming back 6 months later and saying that I never told him that I had a better procedure and didn't recommend it."
Dr. Beitman advises surgeons who aren't yet doing custom procedures to start doing them.
"We now have a procedure available to us that will greatly increase the pool of potential patients," he says. "I don't look at this as a competitive situation. With the outcomes we can achieve with custom LASIK, we'll all be doing more surgeries."
Richard J. Duffey, M.D., of Premier Medical Eye Group in Mobile, Ala., is also a strong advocate for the value of custom treatment.
"I tell my refractive patients that we're not McLASIK. I want them to have the best procedure I can give them," says Dr. Duffey. "If they say they don't have the additional money for custom treatment, I tell them to go home and save up the money. These people understand the value of the highest quality vision correction available for their eyes, and they come back."
Expectations Are Rising
Dr. Duffey will join with David Leaming, M.D., of Palm Springs, Calif., to soon conduct a 2003 ISRS/AAO study of refractive trends. Dr. Duffey says he's eager to see what the surgeons have to say in this year's survey.
"I think you'll see a lot of different answers this year," he asserts. "Surgeons are beginning to understand the significant value that custom LASIK can add to a refractive practice."
Scott Hyver, M.D., of Scott Hyver Visioncare, which has two offices in the San Francisco Bay area, talked to Ophthalmology Management early this year regarding his expectations for custom LASIK. At the time, he made what he called a "conservative" estimate that about 20% of his patients would undergo a custom procedure.
"We've far exceeded that estimate," says Ralph Hyver, marketing director for the practice. "We do wavefront measurements on all of our patients and our first recommendation is custom treatment if they're within the FDA-approved prescription range."
However, the practice serves a large number of teachers and nurses and other working people who say they can't afford $4,600 for bilateral custom LASIK.
"With most of those patients, we feel comfortable performing conventional LASIK, which is a proven technology, for about $1,000 less,"
The Surgeon Should Choose
Holly Cross, senior product manager for practice development, Alcon surgical, says surgeons who recommend custom treatment to all patients who qualify for it are on the right track.
"The patient wants the surgeon to make the choice," says Cross. "A good approach is to tell the patient: "We perform a wide variety of treatments. We have the most advanced technology available today and will choose the best procedure for your individual needs."
Cross says that surgeons shouldn't belittle conventional LASIK to "sell" a patient on a custom procedure.
"We recommend explaining that our CustomCornea system is able to measure and treat things that glasses and contacts couldn't."
Cross says that the incremental costs of performing a custom procedure, such as the higher royalty payment and increased chair time, is permitting CustomCornea surgeons to charge about $500 an eye more for custom treatment than for conventional.
Heather Ready, director of business development for VISX, Inc., says custom treatment "is quickly becoming the standard of care" for laser vision correction.
"With the current approved range of correction, we can already address the great majority of myopes with a custom procedure," says Ready.
Ready believes that refractive surgeons should recommend custom correction confidently for anyone who qualifies, "because it's the best treatment and what a patient is really buying is the doctor's expertise."
Marketing "Custom"
"A key message we use is that a custom procedure can offer individuals an opportunity to attain their personal best vision," says Ready. "We also recommend telling patients that, with our WaveScan aberrometer, we can measure their vision 25 times more precisely than what was previously measurable by standard measures. The idea is to distill your messages down to the ideas that excite consumers."
Ready suggests that practices should consider expanding their marketing of financing options to enable patients to receive custom treatment.
Michael W. Malley, president and founder of CRM Group, which acts as a consultant to cataract and refractive practices, believes that the introduction of custom treatment marks a positive turning point for LASIK after almost 3 years of mainly negative news.
"Already, we're seeing some improvement in procedure volume and fees. I attribute two-thirds of this upswing to increased public awareness of custom treatment and one-third to a slight improvement in the economic outlook and the tax cuts that are putting more money in consumers' pockets," says Malley. "Surgeons who are performing custom procedures using the IntraLase laser can now justify a fee in excess of $5,000 per patient, and the good news is that the higher procedure fees charged by the laser manufacturers will make it extremely difficult for the discounters to offer all-laser custom LASIK for a very low price."
Malley says one good way to reach a large number of potential candidates for custom LASIK is through "drive-time" radio ads.
"You want to reach working people, who make up the majority of the market for custom LASIK," says Malley. "And the best time to reach them is when they're in their cars listening to the radio, with everything else shut out. These radio messages provide an opportunity to talk 'one-on-one' with your target audience. The messages should promote the technology and the potential benefit to the patient. We also encourage a strong call to action such as interest-free financing or "live" custom seminars."
Conducting seminars highlighting the advantages of custom treatment can be an effective way of attracting patients, says Malley.
"The conversion rate from our seminars has been phenomenal," asserts Malley. "To show the difference between custom and traditional LASIK, we'll take two people from the audience who are both -2D with the same basic prescription on paper. We'll then perform the wavefront diagnostics on both of them in front of the audience, and show the significant differences between the two patients' eyes. This drives home our message that no two eyes are alike and no two patients are alike. The audience is very intrigued when we tell them, that for the first time in medical history, we now have the potential to diagnose and treat virtually every imperfection in your eyes."
"Custom treatment is the dramatic breakthrough we've been waiting for to swing the pendulum away from LASIK being viewed as essentially a commodity," asserts Malley. "With new approvals expected to expand the current correction range, we'll be able to offer custom treatment to a growing number of patients."
Some Have Doubts
But practice consultant John Pinto, who has advised refractive surgery practices on their marketing issues since 1984, weighs in a bit more conservatively on the impact of custom LASIK.
"It's unknown at present just what impact custom treatment will have on the refractive surgery market," says Pinto. "Given the generally soft volumes over the past 18 months, we may have to wait for a rise in the consumer confidence figures and the general economy to understand just what incremental case volume and revenue contributions custom ablations can make. My expectations and forecast for the next 12 months are that custom ablations will boost case volumes by no more than 10% in the average practice."
Pinto says it's a mistake to believe that the availability of new technology is a prime driver for increased sales. He says leads and surgical conversions still tend to be primarily driven by the impression made by the surgeon, the facility and the staff.
"It's my view that in the consumer's mind, custom ablations are likely to be perceived a little like the shift from PRK to LASIK," says Pinto.
Interestingly, when Ophthalmology Management recently surveyed a number of refractive surgeons regarding their experiences with custom LASIK, the surgeons who have yet to begin performing custom treatments tended to share Pinto's conservative assessment, while those already doing custom were much more enthusiastic. The conservative view is that custom treatment will occupy a high-priced niche that might be suitable for only 10 to 20% of refractive patients.
"Regular astigmats and simple myopes do fine with current (conventional) technology," says one surgeon, who says he plans on offering custom treatment, but not just yet.
"I would have trouble justifying the cost," says another.
Balancing those views are responses from a number of surgeons who say they began offering custom treatment by using specific criteria to identify candidates, but now recommend it to all qualified candidates.
These doctors all say that the better outcomes they've achieved with custom procedures have convinced them of its value.
"I recommend custom to any patient who falls within the guidelines," says Ernest Kornmehl, M.D., medical director of Kornmehl Laser Eye Associates in Boston. "Custom treatment can provide what I call a 'quality of vision' difference that's evident in improved night vision, better contrast sensitivity, and the elimination of glare and halos. It also appears to be a better procedure for patients with larger pupils."
Changing Perceptions
Holly Cross of Alcon says some critics who downplay the potential impact of custom LASIK may be missing the point.
"The promise for the practice isn't increased volume immediately, but increased profitability immediately, through increased price points," she notes. "In time, improved outcomes will increase word-of-mouth referrals, which will, in turn, improve volume."
However, Cross can tell that custom LASIK is catching on in a big way.
"Most surgeons who have been doing custom procedures for more than 3 months are now doing custom for all patients who fit within the FDA label," she says. "We also know of some refractive surgeons who've changed the name of their practice to include the word 'custom,' " she notes.
And Michael Malley, the refractive consultant, says he knows of a refractive practice that's changed its informed consent form.
"If the surgeon recommends custom LASIK and the patient chooses to have conventional, the patient has to sign a form saying he's not receiving the custom procedure for economic reasons," says Malley.
With that kind of anecdotal evidence, it's a good bet that the 2003 "Trends in Refractive Surgery" survey will show that surgeons have now changed some of their views on the potential impact of custom LASIK.
Applying Custom LASIK Therapeutically |
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Since the concept of wavefront-guided LASIK was introduced years ago, refractive surgeons have looked forward to when they could use it to "fix" patients whose primary LASIK procedures left them with vision problems. Alcon currently has an FDA clinical trial underway for this indication -- 20 eyes done to date -- but far more of these procedures already have been performed off-label. James Salz, M.D., is the medical monitor for the LADARVision therapeutic trial. "Right now, the small number of individual case analyses look good," he said. "The procedures are doing a very good job of treating residual refractive errors, and I'd say they're doing a reasonable job of reducing higher-order aberrations. There are also cases in which higher-order aberrations have been significantly reduced." Dr. Salz said the patients in the trial are just about up to 1 year of follow-up. All eyes had a history of prior surgery with significant visual symptoms. The two most common types of cases are zone enlargements for high spherical aberration and cases where decentered ablations induced coma. Alcon plans to file an IDE expansion request later this year. There's more to learn about some of the more complicated cases before the trial continues, the company says. The algorithm may need to be altered to optimize certain types of treatments. (The software used in the trial so far is the same software that's now commercially available in the United States.)
One of the LASIK patients Dr. Salz treated outside of the clinical trial was a 26-year-old police officer who was originally treated with a broad-beam laser and a 5.5-mm optical zone. His post-op refraction was -0.50 -0.50 x 180 OD and -0.50 -0.75 x 180 OS; acuity in each eye was 20/20. But high levels of spherical aberration and coma were detected by the LADARWave. He complained of "halos, ghosting and doubling," at night. He was using pilocarpine and Alphagan to help control his symptoms. On Feb. 27, Dr. Salz re-treated this patient's left eye, and on April 8, his right eye was re-treated. "He did great," Dr Salz said. His wavefront results for the left eye are pictured to the lower left. Since the FDA approved the VISX CustomVue platform, Robert Maloney, M.D., has used it to perform 15 therapeutic procedures. "It's been remarkable how much therapeutic wavefront treatment has produced an improvement in patients' subjective symptoms," he said. In one of his cases, a 6.25D myope underwent a primary standard LASIK procedure on his left eye, after which he was 20/15 with a refraction of -1.25, -0.50 x 75. After a subsequent enhancement, he complained of poor quality of vision and glare. BSCVA was 20/38 and UCVA was 20/40. Refraction was -0.50, -0.25 x 115. In November 2002, Dr. Maloney performed a therapeutic CustomVue treatment. Three weeks later the refraction was +0.50, -0.25 x 170. By 3 months post-op, the patient reported improvement in his quality of vision; UCVA was 20/32 and BSCVA was 20/20. Dr. Salz recommends that surgeons who are performing therapeutic custom procedures off-label not operate on both eyes at once. "I think if you're careful about who you select, you'll probably do OK," he said. "Do the worst eye first and make sure patients understand that although this is advanced technology, it's not approved for this use on any platform. It represents an off-label use of the laser, and they have to be willing to accept that." -- Ophthalmology Management |