In 1990, something happened to me that changed my life. I moved to Kansas City, Mo., and joined John Hunkeler, M.D., who asked me to handle cornea care and refractive surgery, while he took care of cataracts and glaucoma.

Since then, refractive surgery has become my life’s work. That’s why, as much as anyone, I advocate for the introduction of increasingly varied procedures – and the highest surgical standards possible.

I’ve spent hundreds of hours tracking the outcomes of my procedures, as well as those of my colleagues in our practice. And I recently agreed to serve as chairman of the Council for Refractive Surgery Quality Assurance (CRSQA), an independent Web-site-based group that will educate the public and provide a yardstick for measuring the success of the nation’s refractive surgeons.

Why spend so much time on outcomes? Because we should have zero tolerance for the status quo. Only by continuing to improve will we ensure our progress, especially in this emerging subspecialty.

Because I’ve invested so much time and energy into striving for perfection, the editors of this magazine asked me to write this article. I hope that what I discuss here will help you strengthen your position in refractive surgery, no matter what your current level of experience may be.

I was fortunate to switch to refractive surgery full time at a very early stage in its development. The growth we’ve experienced at the Hunkeler Eye Center has taken us from zero procedures to nearly 8,000 procedures expected by the end of 1999. We now have more laser-assisted in situ keratomileusis (LASIK) surgeons (11) in our practice cluster than we do cataract surgeons (nine).

Combining facility fees and surgeons’ fees, we’re predicting refractive surgery to be nearly a $9 million revenue center in 1999. Between 1994 and 1998, we achieved progressive increases in the percentage of our net revenues from refractive surgery, increasing them from 7% to 45%. But it’s also important to note that, in 1998, we enjoyed an average 30% growth in all other areas: Oculoplastics, glaucoma, retina and cataract. The rest of our practice is growing because of new relationships we’ve been making through refractive surgery.

Since I began my work in refractive surgery in 1980, I’ve used 24 types of procedures – from radial keratotomy (RK) to intrastromal corneal ring segment implantation (Intacs).

RK got our profession started, creating consumer awareness and building practices. Then, from 1993 to 1996, we had the photorefractive keratectomy (PRK) wave. Now LASIK is growing from 20% of all cases to 85% of all U.S. refractive surgeries projected by this December.

We’re not only growing in terms of the number of procedures, we’re switching procedure types as new approaches evolve. Here lie our unexplored opportunities. (See "New Options on the Horizon" at the end of this article.)

The keys to success in refractive surgery are identifying ideal candidates – and also studying your results as part of a continuing analysis. Your findings may vary significantly from what you might expect. In my practice, for example, I’ve found that our classic LASIK patient is a 43-year-old, 6D myope with quite a bit of cylinder. This clearly illustrates that LASIK isn’t just a procedure for young people.

I’m treating hyperopic patients, but we’re not even scratching the surface of this part of the market. A little more than half of people in the United States need vision correction. Of that number, 52% need hyperopic correction, as opposed to 48% needing myopic correction.

It’s clear that hyperopia represents our biggest potential opportunity, once hyperopic technologies are mainstreamed in the months ahead (with FDA approval of laser thermal keratoplasty [LTK] and the Summit hyperopic laser expected by year’s end) and in the years ahead.

Remember that the high level of myopia (>6.00D) we’re primarily targeting now represents less than 1.2% of the refractive surgery population. With all this in mind, I urge you to resist the feeling that you've missed the opportunity to enter refractive surgery aggressively. Despite robust growth in the field in recent years, plenty of market share remains. We need to focus on the tremendous untouched territory out there.

To measure how our profession has been doing, I started a Web site outcomes company (DataSite) a few years back. It has provided valuable data that help identify trends as we continue to grow. This type of analysis is the cornerstone of a successful refractive surgery practice.

In our practice, we wanted to know what percentage of our patients are now 20/20 or better, and how the results of different procedures on different types of patients compared. Here’s what we’ve found so far:

• LASIK has produced better immediate results than PRK.
It’s helped nearly four times as many people see well enough to drive a car without correction (at 20/40) the day after surgery. However, only 50% of post-LASIK patients end up with 20/20 vision in published studies, suggesting a need for improvement.
Obviously, the quality of vision without glasses was very poor preoperatively and was markedly improved postoperatively. But these patients aren’t yet telling us that their post-op vision is excellent.
• Preoperative contact lens wear made a difference.
Patients who wore rigid gas permeable contact lenses before surgery experienced fewer outcomes of 20/40 or better than patients who wore soft lenses before surgery (84% vs. 90%). Also, as expected, more patients in our practice who’d been wearing contacts underwent surgery than those who’d been wearing spectacles (2,644 for contacts, 1,366 for spectacles).
• We’ve solved glare problems.
Preoperative to postoperative glare, a big problem with RK, decreased in LASIK patients. Even haloes, an issue we needed to address in larger optical zones, showed no significant increase in LASIK cases.
• We’ve virtually eliminated pain.
On a 1 to 10 scale, most patients reported a 1 after LASIK. They were very satisfied with their surgery, which is good, but we still haven’t reached 100% satisfaction.
• We can also improve as a profession with our number of complications.
The findings of Doyle Stulting, M.D., and George Waring, M.D., from the January 1999 issue of Ophthalmology, based on the outcomes of 1,062 cases performed by 14 surgeons, show 2.1% of refractive surgery patients experienced intraoperative complications. And 5.3% had postoperative complications, especially in the area of epithelial in-growth and flap slippage.
It’s important for you to realize, however, that these surgeries were performed quite a while ago, with first generation microkeratomes and lasers. Nevertheless, this is the information that’s available now.
• The need for enhancements has decreased – but not enough.
Some 36% of the patients in the Emory University Studies (1995-1996) needed enhancements, and 69 of 381 needed a second or third enhancement.
• In a 1997 series by Tom Clinch, M.D., showed 16% of the patients had to return to the operating room after LASIK to achieve the results they wanted.

Also, complications and epithelial ingrowth became problems with enhancement procedures. (The Emory enhancement complications findings: 11 out of 381, or 2.9% of patients, experienced complications; nine of these (2.4%) in-volved epithelial ingrowth. Our recent enhancement complications, including epithelial ingrowth, were at 0%.)

So if we look at the results overall, patients have been very satisfied. The results have been good, but not great, despite rapid growth. The complication rates and the enhancement rates, in my mind, have been too high.

What can we expect in the future based on these results? What goals should we establish and how should we do things differently to achieve these goals? I’ve reached conclusions in the following areas, based on outcome trends in the most recent group of consecutive patients in our recent series.

• Visual acuity.
None of our patients lost two lines of vision, which shows improvement. All of the post-op patients were correctable to 20/20 at 1 month.
Also, looking at the uncorrected visual acuity, the 20/20 rate was creeping up to 70%. We’d like that to be higher, but at least it’s rising. Now, we should no longer aim for 20/40 or better. Patients want to see 20/20.
• Standard deviation
. We’ve improved the standard deviation of error in our practice, reducing it to below a half a diopter. You can accomplish this goal by looking at your data and adjusting your algorithms. And you need to establish a range that doesn’t produce surprise outcomes, in hopes of keeping the deviation from your target at 80%, within plus or minus a half diopter.
• Diopter ranges.
Another interesting finding in my most recent series is that I’ve seen very little difference between our 1-to-4-diopter group and the 4-to-11-diopter group. The results were no better in the lower group, and they were no worse in the higher group, both in terms of achieving accuracy and in terms of achieving 20/20 vision.

Once you’ve got a firm handle on outcomes like these, you want to use them to raise the bar on quality. For example, among both the experienced and inexperienced surgeons in our practice, we haven’t had a single flap complication in the 5,200 or more eyes we’ve operated on since July 1998.

In part, this is because we’re following a standard protocol. For example, we use a new blade and separate, sterile equipment for each eye and the same wording for instructions by the various surgeons. Standardized paperwork for all cases also serves to help the staff make things run smoothly.

Our practice also has upgraded our lasers and microkeratomes. We are now using the Hansatome microkeratome (compared to the Acs microkeratome in the Emory study), the Summit Apex Plus laser, the Nidek EC-5000 and the Bausch & Lomb 217.

With this most recent track record, we’ve seen a dramatic improvement in outcomes. It sets a new standard for our surgeons. Nobody wants to ruin our streak of successes. Now that we have these complications at zero, I keep the pressure on to maintain this new high level of status quo.

We haven’t eliminated partial flap slippage that needs to be refloated, but we’ve eliminated the epithelial ingrowth just by watching our technique and working to make it safer. Our overall complication rate in our last large series (5,200 eyes) of LASIK procedures is at 0.06%, compared to 5% complication rates in the published literature.

We’ve also dropped our enhancement rate from 15% in 1997 to a little below 6% – all by looking at the data and continuing to improve.

Refractive surgery standards by the end of 1999 will call for lasers that can correct myopia, hyperopia and astigmatism in the range in which LASIK works, essentially 0 to 12 diopters, and astigmatism and hyperopia up to 5 diopters.

Other trends to look for:

• Smooth ablation will be required.
Smooth ablation is necessary for reliable results. The laser industry is working on this goal.
• Costs will decrease.
More competition among laser makers will drive this dynamic.
• Microkeratomes will improve.
Water jet technology is developing, as well as other technologies. Competition among microkeratome makers will help us perform better procedures – and increase competition among surgeons.
• The standard will be zero flap complications.
Now that one group of surgeons has met this goal, we need to shoot for it all of the time. We’ll need microkeratomes that produce a superior universal hinge, are easy to clean, are disposable (if possible) and that have high quality blades. These will enable us to turn over patients quickly. Of course, reasonable cost will also be a factor.

As you can see, the details involved in improving refractive surgery go on and on. But the effort is well worth it if you can improve outcomes and satisfy more patients. Individually and collectively, we have the opportunity write a new script in the history of our profession – as long as we don’t ever become content with the status quo.

All of us in the expanding field of refractive surgery have worked with basically the same laser, whether it be a Summit or VISX. But now lasers are coming from more sources. Consider:

• Bausch & Lomb is about to become a big player.
The Technolas 217 is awaiting FDA approval. Also, B&L recently purchased Orbtek’s corneal topography system, significant for performing customized ablations. Remember that B&L also now owns Chiron, the maker of the Hansotome microkeratome.
• Nidek is moving ahead.
Despite legal battles over patents, the EC-5000 has been approved for -0.75D to -13.0D of myopic correction. Nidek aims for approval of up to 4.0D of astigmatism correction and, eventually, hyperopic correction.
• Autonomous Technologies is set to expand under Summit Technology ownership.
The company’s "flying spot" LADARVision system has been approved for -1.00D to -10.00D of myopia with or without astigmatism (up to -4.00 diopters.)
• Sunrise Technologies is expected to gain approval later this year for its laser thermal keratoplasty (LTK) for hyperopes.
Correcting from +0.75D to +2.50D, this procedure will help us tap into a hyperopic market of 25 million people.
• LaserSite Technologies is nearing FDA approval.
The firm’s scanning 1 mm Hz excimer laser should soon be approved for 1.5D to 10D of myopia, including 1D of astigmatism. LaserSight is also developing a corneal topography mapping system, ScanLink, that will help create customized ablation patterns.
• Intacs (intrastromal corneal ring segments) will come into full use following their recent FDA approval.
Using them will offer you the opportunity to provide a non-laser procedure that’s reversible for myopes in the -1.00D to -3.00D range.

The Council for Refractive Surgery Quality Assurance (CRSQA), which Dr. Dan Durrie is heading as chairman, was formed to provide objective information about refractive surgery.

"Eyecare professionals who wish to earn the CRSQA stamp of approval will have to demonstrate outcomes that meet certain standards," Dr. Durrie said.

The standards will be determined by CRSQA, whose members include ophthalmologists, optometrists, industry representatives, allied healthcare professionals, refractive surgery patients and consumer advocates.

The group is applying for non-profit status in California.

"CRSQA certification will not be a one-time event," Dr. Durrie said. "We intend to monitor outcomes on an ongoing basis."

Besides certification, CRSQA will provide educational opportunities to professionals and the public. The Web site (http://www.usaeyes.org) is up and running, offering information about CRSQA and the various refractive surgical procedures now available. Once CRSQA establishes its certification process, the site will provide contact information for all CRSQA-certified refractive surgeons.

The group will also handle complaints from patients, suggest remedial action for surgeons (when appropriate) and also withdraw certification from surgeons who don’t continue to meet CRSQA standards.