Outcomes are better than ever, but its place as the dominant refractive procedure is now in doubt.
By Jerry Helzner
PHOTOTOGRAPHER: MARK HARMEL - GETTY
After almost a decade in the spotlight, LASIK has earned hard-won acceptance from the general public and, according to the 2003 ASCRS survey of U.S. Trends in Refractive Surgery, has become the dominant form of refractive surgery for refractive errors ranging from -8D to +3D. The advent of wavefront-driven custom ablation and, to some extent, the introduction of laser-cut flaps, have enabled surgeons to measurably improve outcomes and make the procedure even more appealing to patients. That appeal is reflected in the numbers. In another survey conducted earlier this year, approximately 70% of the refractive surgeons polled said they expected their LASIK procedure volume to increase by 10% or more this year.
Given all the good news, it would make perfect sense to conclude that LASIK has firmly established itself as the refractive procedure of choice for a long time to come. In reality, just the opposite is true. Ophthalmology Management recently conducted in-depth phone and e-mail interviews with more than 20 of this country's leading refractive surgeons. Overall, their responses reveal that the public has embraced the almost-instant gratification offered by LASIK to a far greater extent than many of the surgeons who have extensive experience performing the procedure. At the same time, several of the country's leading refractive surgeons say it will take highly compelling evidence to dethrone LASIK as the procedure of choice for most patients.
In this article, we'll examine why so many refractive surgeons have reservations concerning LASIK. We'll also explore their views on other aspects of laser vision correction, including:
► the potential of surface ablation and lenticular procedures to surpass LASIK
► the need for finding more accurate ways to measure refractive outcomes
► appropriate refractive surgery pricing
► the outlook for helping more patients who require therapeutic ablation
► prospects for improvements in refractive surgery
► ideas for creating efficiencies in patient flow in the new era of wavefront (see "Achieving Efficient Patient Flow with Wavefront" on page 34).
Surgeons Have Concerns
In interview after interview, surgeons mentioned serious flap complications as the main reason they've either stopped performing LASIK or are seeking less invasive alternatives.
"We've all had to deal with flap complications. The danger is small, but real," says Marguerite McDonald, M.D., clinical professor of ophthalmology at the Tulane University School of Medicine. "LASIK is a high-stress procedure for surgeons. It's been proven by Dr. Ramon Naranjo-Tackman of Mexico that surgeons' heart rates go way up during the cutting of the flap, and the incidence of PVCs, PAT and short runs of ventricular tachycardia go up as well."
Dr. McDonald stopped doing LASIK a year ago because of the superior wavefront outcomes she achieved with surface ablation. She now does 'modern PRK' using chilled balanced salt solution (BSS) after the last laser shot and 'comfort drops' of weak tetracaine, and is also doing more epi-LASIK this year (some surgeons call this procedure epi-LASEK because it's more closely related to LASEK than to LASIK). With either iteration of surface ablation, she tells her patients that she can do their laser surgery without using a cutting blade and says they're happy about that. She says the risk/benefit ratio is still in favor of surface ablation over LASIK.
Dr. McDonald expanded upon what she believes are the superior clinical results of surface ablation when it's performed as wavefront-guided surgery.
"With wavefront-guided LASIK, any microkeratome will create sudden biomechanical changes that in turn cause the sudden induction of changes in the patient's higher-order aberrations. These changes in the wavefront map can't be predicted, nor can they be incorporated into the surgical plan," she notes. "Surface ablations are therefore a better way to take fuller advantage of the benefits of wavefront-guided surgery."
And from Johnny Gayton, M.D., of Eyesight Associates in Warner Robins, Ga., "More ophthalmologists will use surface ablation as it's clearly the best method for treating higher-order aberrations."
Though most of the surgeons we interviewed continue to perform LASIK, many of them prefer to do PRK, LASEK and the increasingly popular epi-LASIK. In epi-LASIK, a device called an epikeratome with either a dulled metal or PMMA oscillating separator is used to create a hinged epithelial sheet that is then laid back onto the freshly ablated corneal stroma immediately after laser treatment to decrease pain and speed the return of vision.
Epi-LASIK Shows Promise
"We may see incremental improvements in LASIK and PRK, but epi-LASIK has the most upside in terms of making it a superior procedure," says one surgeon.
Barrie D. Soloway, M.D., F.A.C.S., director of Vision Correction, The New York Eye and Ear Infirmary, and assistant professor of ophthalmology, The New York Medical College, performed the first epi-LASIK in the United States that used Moria's Epi-K epikeratome. He notes that the epikeratome represents a major improvement in LASEK because it eliminates the need for using cell-killing alcohol in removing the epithelial sheet.
"Once we can improve surface ablation to the point at which patients can wake up the next morning and go to work -- and we're just about there with epi-LASIK -- it will be the procedure of choice," asserts Dr. Soloway. "I'm not sure who would need LASIK then, with its problems of dryness, flap complications, ectasia, and the severing of nerves on the cornea."
"The only two real objections to surface ablation have always been that surface procedures cause more patient discomfort and offer slower vision recovery than LASIK," says Thomas V. Claringbold II, D.O., of the MidMichigan Physicians Group in Clare, Mich., who performed the first epi-LASIK in the United States that used Norwood Abbey's Centurion SES Epi-Edge epikeratome. "With epi-LASIK, we're seeing great improvement in both of those areas. Within 5 years, epi-LASIK could easily become the surgical procedure of choice. For some of us, it is now."
"The outlook is quite bright for surface ablation," says Stephen S. Lane, M.D., clinical professor of ophthalmology at the University of Minnesota. "We still have a ways to go in determining how good 'epi' can be, but surface ablation could take off like a rocket."
Virtually every surgeon we interviewed who currently performs LASIK, including those who are most positive about the future of the procedure, say they are closely following new developments in surface ablation, but are waiting to see more proof that patient discomfort can be reduced and the vision recovery period shortened.
Richard J. Duffey, M.D., of Mobile, Ala., is among those who need to be convinced that surface ablation can be a superior procedure.
"Right now, perfect LASEK/PRK candidates are patients with thinner corneas in whom ectasia is a higher risk, those with very steep or flat corneas, and patients with orbital anatomy making it difficult for placement of a microkeratome. Surface ablation could surpass LASIK in the future if the recovery period could be significantly lessened and approach the short recovery time LASIK offers, and if discomfort associated with surface ablations can be significantly reduced or eliminated."
Many surgeons, including those who speak highly of surface ablation, are looking even further ahead, to a day when phakic, accommodative and multifocal IOLs can be perfected to the point at which they can replace laser vision correction entirely.
One of the leading figures in that camp is I. Howard Fine, M.D., clinical professor of ophthalmology at the Casey Eye Institute, Oregon Health and Science University, and a highly regarded thought leader in ophthalmology. Dr. Fine strongly believes that rapidly improving IOL technology will soon make refractive lens exchange the procedure of choice.
"Refractive lens exchange will come to dominate refractive surgery in the near future," asserts Dr. Fine. "It's the least invasive vision correction procedure. It doesn't require a major capital investment by surgeons and will give patients the best possible vision for decades without any chance of ever getting cataracts. New accommodative and light-adjustable IOLs on the horizon will make refractive lens exchange an even more compelling choice."
"If we had a lens truly able to restore 3D of sustained accommodation, providing the benefit of near-to-far focusing, there would be no debate about which procedure is best," adds John A. Vukich, M.D., surgical director for the Davis Duehr Dean Center for Refractive Surgery in Madison, Wis. "We would do that procedure for everyone."
One of the major selling points that's been used to promote LASIK is that patients regularly display 20/20 or better vision after having the procedure. But even that benefit of LASIK has come into question as more refractive surgeons now contend that contrast sensitivity, patient satisfaction, and the ability to perform real-world functions are more important tests of vision quality than a raw 20/20 measurement.
"We're all starting to realize that we need better metrics to measure quality of vision as related to such functions as night driving," says Dr. Lane. "I think we're seeing a rebirth of contrast sensitivity testing. Also, we should think about using aberrometers to measure higher-order aberrations, some of which may actually improve vision."
Some surgeons now use the phrase "20/20 Happy" to describe patients who are not only 20/20 or better, but who are also pleased with their overall functional vision.
"I feel the best metric for refractive surgery outcomes is patient satisfaction," says Dr. Duffey. "When we see enhancement rates decrease and hear fewer complaints of night-vision problems, then we will have achieved superior outcomes with custom ablations. To date, my retreatment rate has not been reduced by custom ablations, however we rarely if ever see patients who complain of night-related vision problems since the advent of custom ablation in our practice."
Robert K. Maloney, M.D., of the Maloney Vision Institute, adds: "Some patients see 20/20 but complain of quality of vision problems because of aberrations. As 20/15 and 20/12 become the expected outcomes from LASIK, best-spectacle-corrected acuity becomes the metric of choice, because it's almost impossible to have significant aberrations and see 20/12."
Steven Schallhorn, M.D., director of cornea and refractive surgery, Navy Medical Center, San Diego, is concerned with giving Navy pilots the best possible vision that could help them in life or death situations. He's currently conducting extensive tests to determine what type of vision correction provides the best functional vision.
"We use a variety of tests to determine overall quality of vision, including contrast sensitivity, best uncorrected visual acuity, subjective responses from patients, and a night-driving simulator that determines such things as a person's ability to read road signs. If one type of vision correction procedure produces a significantly better quality of vision, we'll certainly move in that direction."
Dr. Schallhorn points out that "there's no marketing element in the military. We will be driven to set our standards by the studies and data relevant to quality of vision that are sure to be available over the next few years."
One such study consists of soon-to-be-published research conducted by Dr. Claringbold and a team at Central Michigan University. In a test designed to measure the ability of LASEK and LASIK patients to both drive and read a GPS-generated map display in a vehicle under various lighting conditions, the LASEK patients scored 25% higher than the individuals who had received LASIK.
"Those who had LASEK even scored 5% higher than individuals who had no vision correction procedure at all," says Dr. Claringbold. "These studies that test real-world functional vision are likely to become more important as more of this type of data is gathered."
"Snellen acuity clearly doesn't tell the whole story," says Dr. Vukich. "Any new metrics we adopt must be able to show us quality of vision. If these simulator studies produce compelling data about functional performance, I'd pay attention to it."
Setting a Fair Price
All of the LASIK surgeons we interviewed for this article say they're performing custom procedures on the majority of their patients.
Almost all of the surgeons who only perform surface ablation also take wavefront measurements as part of the basic work-up. With wavefront requiring more time and technology than conventional LASIK, surgeons say they're pricing procedures to reflect the added cost and effort. And market research shows that patients have been willing to pay more for a better procedure. The latest survey of surgeons by the industry-tracking publication Market Scope shows an average price for laser vision correction near a 3-year high at $1,785 an eye. However, practices have several ways of approaching the pricing issue.
"I compare the custom procedures we can now offer to patients to conventional LASIK in the same way I would compare the new high-definition televisions (HDTVs) to conventional TVs," says Daniel S. Durrie, M.D., of Durrie Vision in Overland Park, Kan. "People are willing to spend thousands for an HDTV. Why? Because they're getting a vastly superior product. Today's LASIK patients are getting a premium procedure. It's a better value for them and we shouldn't undervalue the service we're providing."
Dr. Durrie charges $2,500 an eye for a custom procedure, with no extra fee for wavefront. He notes that his rate for implanting accommodating or multifocal IOLs is $4,500 an eye.
George Waring, M.D., founder of InView Vision in Atlanta, says he hasn't changed his LASIK price in 10 years.
"I've always done the best procedure for the patient and I've always charged a premium price, with no extra fees at all. That's allowed me to incorporate the new technology into my practice without changing my overall umbrella price, which covers everything."
Dr. Waring offers refractive patients a preview of how the procedure will correct their vision by using a simulator that his practice has developed.
"The simulator takes everyday images, presents them with varying amounts of contrast and with spherical aberration and with defocus, so the patient can compare the sharp image anticipated after surgery with the other images," says Dr. Waring. "This also gives the patient more realistic expectations because they are more familiar with some post-op aberrations before surgery, even though the purpose is to show the problems we are minimizing."
Like many surgeons, Michael Korenfeld, M.D. of Comprehensive Eye Care, Ltd. in Washington, Mo., charges a premium for wavefront-guided procedures. Dr. Korenfeld is among the surgeons who believe that the wide adoption of wavefront will eventually work to the advantage of surface ablation.
"The LASIK flap has always introduced distortion into the postoperative wavefront, and although those effects are often small, they can be very significant. Wavefront-guided treatments are likely to move surgeons away from LASIK."
Some practices have another way to price laser vision correction. They have a tiered structure based on the amount of refractive error and astigmatism that need to be corrected. Of the surgeons we interviewed, only two use a tiered pricing structure.
When Plans Change
One of the least-discussed areas of LASIK is the number of potential patients who come in to a surgeon's office with their heart set on having LASIK and are told that LASIK isn't suitable for them.
"Good surgeons are selective, eliminating those with corneal pathology such as keratoconus, refractive errors that are too high and even those patients with unreasonable expectations," says Dr. McDonald. "Every month, a good refractive surgeon turns down at least a few of the people who present for laser vision correction."
Dr. Vukich says it's sometimes difficult for a patient to accept that he or she can't have LASIK.
"Often they've thought about it for a while and finally made the decision to have the procedure," he says. "Their thinking is: 'My friends have had it and they like the results, so I'm ready for it now.' Then, if I tell them a lens-based procedure will be better, they sort of take a step back. It's my job to educate them about a procedure they may not know much about, so I expect them to go back and do a little more thinking about it."
Dr. Vukich says he knows he "loses" a certain percentage of the patients who initially come in for LASIK, but says many of them have nothing done and then eventually come back and accept a different procedure.
David R. Hardten, M.D., of Minnesota Eye Consultants, says patients are showing increased acceptance of the entire range of refractive surgery.
"If I tell them that a procedure other than LASIK will be better, they usually tolerate it very well," says Dr. Hardten. "Most of these patients just want their vision corrected, and in our practice the prices for different procedures are fairly similar. I counsel them and tell them to come back with more questions. It's appropriate to give them some time to make a decision if they feel that they don't have all the information they need to make a decision."
Using Lasers to Heal
One of the more promising aspects of wavefront-guided laser procedures is their potential to heal highly aberrated eyes resulting from disease or previous corrective surgeries.
The surgeons we surveyed are almost unanimous in their belief that a large-scale clinical trial of therapeutic ablation will be difficult to conduct because of the diverse nature of the patient base. However, several surgeons noted that therapeutic ablation is an area in which ophthalmologists can help each other by sharing information about what they've learned in treating specific types of problems.
The most difficult challenge is the wide range of pathology encountered in patients needing therapeutic treatment," says Roger Steinert, professor of ophthalmology at the University of California, Irvine. "We use wavefront-guided treatments therapeutically when the patient has symptoms that correspond to the wavefront aberrations."
"Therapeutic ablations include such a broad spectrum of corneal problems that it is very difficult to set guidelines that are appropriately applicable to most patients," adds Dr. Duffey. "No two patients are exactly alike."
Dr. Marguerite McDonald, who has a backlog of complicated cases waiting for therapeutic ablation, says the new Fourier software should provide a major advance in treating highly aberrated eyes.
"Dr. Julian Stevens of Moorefield's Eye Hospital in London is the world leader in the area of therapeutic ablations, and his results with the Fourier-based treatments are very impressive," says Dr. McDonald.
Is Consensus Possible?
When you talk to more than 20 top refractive surgeons, each with his or her strong opinions, it's difficult to achieve unanimity on any issue. Dr. Soloway and Dr. Claringbold may believe strongly that surface ablation and epi-LASIK can overtake LASIK, but surgeons as respected as Dr. Robert Maloney and Dr. Roger Steinert just as strongly believe that LASIK will be around for a long time. Taking the middle ground are a number of surgeons who see the potential in both surface ablation and lenticular options, but who want to see more improvement in the technologies supporting these modalities. Asked about the potential impact of advances such as the crystalens accommodative IOL and the Array multifocal lens, one surgeon simply called them "a good start that needs to be improved upon."
"But just as lens removal technology continues to improve, corneal surgery will also continue to improve," notes Dr. Gayton.
"There's no single technology that has no drawbacks right now, though each has its own inherent advantages," says Dr. Hardten. "For every vision correction procedure there are still technological issues to be worked out. It's hard to predict what will happen, as we're really in a kind of technology race. But the promise of having a range of constantly improving procedures to offer patients is very real."
Achieving Efficient Patient Flow with Wavefront
Integrating wavefront into a refractive surgery practice translates to performing more tests, spending more time with patients, and making sure you have a highly trained team with the skills to take on additional critical responsibilities.
Advice on how to achieve efficient patient flow with wavefront abounds. In interviews conducted by Ophthalmology Management for this article, we received responses ranging from the highly optimistic: "Just do it and you'll soon settle into a routine that fits your practice." To the depressing: "We still haven't figured out the logistics of performing wavefront procedures."
In implementing wavefront, two basic questions immediately come to the forefront. First, should you have dedicated techs to perform the wavefront exams? Based on the responses we've received, the answer to that question is probably "yes." One exception would be in practices that are fortunate enough to have a team of long-time trusted technicians who can be cross-trained to perform a variety of complex functions. Another exception would be a smaller practice with a single surgeon performing fewer than 10 refractive procedures a month. Michael Korenfeld, M.D., of Washington, Mo., falls into this category. He performs all the preoperative measurements himself, except for the wavefront capture, which is obtained by the director of the surgery center.
The other question is whether the primary wavefront exam and surgery should be performed on the same day. This issue is somewhat complicated by the fact that some laser platforms require dilation and others don't. For example, surgeons who use the Alcon system, which requires dilation, often do the wavefront exam and surgery on the same day, while surgeons using the VISX system, with no dilation, tend to do the basic wavefront as part of a preoperative work-up, and the surgery on another day.
Commit to Wavefront
David R. Hardten, M.D., of Minnesota Eye Consultants asserts that the first step to efficient wavefront implementation is for the practice to make a full commitment to the technology.
"You can't just do wavefront for a few exceptional cases," he says. "Do it for the large majority of your refractive patients and you can develop efficiencies. And remember, though wavefront procedures require more time, you'll make up a lot of that time later because you'll have better outcomes and have to perform fewer enhancements."
Stephen S. Lane, M.D., clinical professor of ophthalmology at the University of Minnesota, speaks for many surgeons when he says the key to successful implementation of wavefront is to have highly skilled techs. Dr. Lane has a dedicated technician to perform his wavefront exams.
Roger Steinert, M.D., professor of ophthalmology at the University of California, Irvine, has a surgical team "captain" who coordinates patient flow and the actions of all team members.
"We communicate verbally at each break point about who is expected to do which task, and what we should be doing next."
Daniel S. Durrie, M.D., of Durrie Vision in Overland Park, Kan., says he could do four conventional LASIK procedures in an hour "and we're now doing four custom procedures in an hour."
Dr. Durrie says his practice was able to achieve efficiencies with wavefront by making a variety of adjustments.
"We did some time studies, some retraining, shifted some positions and assigned dedicated techs to do the wavefront exams," he notes.
Several surgeons advise doing topography just after you do the wavefront map, as both tests require a pristine tear film.
Remember the "T's"
Ella G. Faktorovich, M.D., of Pacific Vision Institute in San Francisco, Calif., says the way to successful wavefront-guided outcomes is to remember "The Four T's" -- Technology, Technique, Technician and Tear film.
Though she uses the Alcon platform, her basic approach to wavefront, in sum, consists of the following:
Technology and Technique: Make sure that an accurate wavefront map is obtained and that there's good correlation between wavefront refraction and subjective refraction. Take all patients out of contact lenses at least a week prior to treatment, and longer if they wear RGP lenses and/or corneal topography looks abnormal. Patients should use lubricating drops at least four times a day in the week prior to surgery.
During pre-op exam, all baseline tests, including wavefront, are performed. When a patient arrives on surgery day, a technician preps the eyes. Marks are placed at the slit lamp. On average, three wavefronts are performed and analyzed for the accuracy of data points. Wavefronts from surgery day should be similar to the wavefront performed during initial testing. For more accurate outcomes, valid wavefronts should be obtained at least 0.5 mm wider than the optical zone.
Technicians: "Your technicians are critical to the entire process," says Dr. Faktorovich. "I have two dedicated techs ---one is an optometrist and the other a software engineer. Both are also artists. I think that's a perfect combination, as wavefront-guided procedures combine science and art."
Tear film: Dr. Faktorovich places a high priority on patients having stable tear film. If a patient has an abnormal wavefront map on the day of surgery due to unstable tear film, she'll reschedule the surgery for another day.
The advice provided in this article is general. For additional guidance on integrating wavefront into your practice for a specific manufacturer's platform, the companies that produce equipment for custom procedures are more than willing to provide printed material and advice on how to achieve efficient patient flow with their products.