The future has arrived. Today, for the first time in a long while, we have a full range of laser options available in the U.S. Back in 1996, the approved range for myopia was only 1D to 7D. We couldn't treat astigmatism or hyperopia, and we only had two laser companies from which to choose.

Today, with the recent FDA approval of hyperopia for VISX and Summit lasers, the approved treatment ranges have really opened up. Now we can treat 1D to 14D of myopia, up to 5D of astigmatism and up to 4D of hyperopia. Essentially, we can treat the maximum ranges that are good for patients.

Our laser choices have also expanded dramatically. We now have Lasersight, Nidek and Autonomous, as well as pending approval of the Bausch & Lomb Technolas 217 lasers. By this spring we should have six lasers available for myopia and astigmatism, with two approved for hyperopia. And nearly every doctor has access to a Summit or VISX laser, even if it isn't their primary laser. One is usually available in town or somewhere in the region.

Because of these changes, we can now meet the needs of 99.5% of the patients who come into our offices for refractive surgery. This means that, except for a rare patient, everyone is a candidate.

Clearly these changes benefit both our patients and ourselves. However, they also call for a change in approach to our patients.

The issue used to be, how much will I be allowed to do for this patient? But now that most of those limitations have been lifted, the question should be: Is this treatment really what this patient needs?

Too many doctors are in a hurry to use laser technology on everybody. In today's refractive surgery environment, they find it hard to say no. Then they get into trouble trying to treat that 0.5% of patients who aren't good candidates -- those at the ends of the ranges, both low and high, and those with other contraindications.

I think saying no to these patients is just fine. I'm constantly getting topographies from docs who are having problems and wondering what they should do next. They've treated patients whose corneas were too flat or steep, or they've ex-tended the range inappropriately. My advice? They shouldn't have treated these patients in the first place.

For example, we can now offer laser options to a high myope -- above 10D. But should we? Before we do, we have to consider a number of factors:

Is the cornea thick enough to have more than 10D of myopia corrected? It's imperative to use pre-op pachymetry to measure the central corneal thickness of any laser patient and calculate how much tissue will be removed. As you know, the patient must have a residual corneal thickness of at least 410 microns. (This is especially significant for the growing number of patients 10D and over who want LASIK. These patients are at risk for losing the most corneal thickness.)

Does the patient have mesoptic dilation of 6 mm or greater? This patient is more likely to have halo and glare problems if you correct more than 10D of myopia.

What's the patient's corneal curvature? Most surgeons believe that after surgery the cornea shouldn't be any flatter than 32D (some say 34D). That makes the high myope more complex than the standard patient.

Even though it will probably be 2 years before implantable lenses appear on the market, patients who aren't good candidates for laser procedures should be told that there are alternatives under development that may be better for their eyes.

As more lasers receive approval, pricing and services offered will become more competitive. However, the effect on patient selection will probably be minimal. That's because new players in the field will be getting approval for approximately the same treatment ranges we already have.

Increasing choices may have a significant impact on doctors, however. The purchase of a laser is a big decision -- it links us with one specific company, for better or worse. Most of us are looking for a company that offers multiple products and services, a company that can service the whole clinic and surgery center, not just provide a laser.

For example, the Bausch & Lomb approval will be significant. Bausch & Lomb is a large, ophthalmic-based company that sells microkeratomes, pharmaceuticals, phaco machines and IOLs. With the purchase of Orbtek they've made a commitment to refractive surgery, and the Technolas 217 is one of the leading lasers in the world. A lot of doctors who like to work with big companies may choose to go with them.

VISX and Summit are still clearly the market leaders, and they'll continue to be the leaders; VISX has 75% of the market and Summit has 20%. These companies are solid, and they're going to be working hard to preserve and increase their market share.

Nidek also makes lots of equipment that's used in doctor's offices, including autorefractors, lensometers, cameras for diagnostic purposes, and other lasers for YAG and Argon procedures. They're certainly capable of putting together an attractive multiple product package.

The pricing of lasers has already changed dramatically. I don't know of anybody who writes a check to buy a laser anymore. All of the pricing now is done via leasing – providing service and ongoing technological development on a per-procedure basis. As a result, it won't be the price of the laser, but the price per procedure that doctors will be looking at.

At the moment, the actual price any given doctor will pay appears to be volume dependent. If you perform 15,000 procedures per year, you're probably going to pay less than somebody who does 100 per year. Hopefully, prices in general will drop over time as the technology continues to improve.

From our perspective, charging per procedure is great; it makes it easier for us to develop a budget when we know how much the laser will cost each time we use it. We can charge the patient accordingly. It's a much more convenient way to work.

Other patients who aren't ideal candidates for today's laser surgery are those who have asymmetric or irregular astigmatism. Currently approved lasers can only make circles or elliptical patterns on the cornea. Neither of these will produce optimum results for these patients.

All of the laser companies are working on the technology necessary to perform customized ablation, so barring unexpected surprises, customized ablation patterns should be available within the next 2 to 3 years. Patients with asymmetric or irregular astigmatism constitute a small group, but they may benefit from waiting until this technology becomes available.

Some companies currently have the technology to perform customized ablations, but they're still doing clinical trials. Autonomous is conducting an ongoing feasibility study on 40 patients. They were the first to start, and they're in the lead at the present time. VISX has announced their collaboration with Josef Bille, who has wavefront technology, and they're going to start their customized ablation project soon. Bausch & Lomb has topography-guided technology, as well as a wavefront analysis machine. Nidek also has a customized ablation program they've been working on for several years.

Having this technology in the pipeline works to their benefit, because they can offer customized ablations as a future benefit of choosing their lasers. (Every doctor who makes an investment in laser technology wants to know that he'll be able to treat extended ranges down the road.)

How much of an advantage this technology will be for our patients remains to be seen. (See "Keeping Advances in Perspective" to the right.)

To be honest, I don't think there will be any significant expansion of technology during 2000. We may get approval for treating hyperopes with astigmatism, but we can already handle those patients with a two-stage approach (surgery for hyperopia plus surgery for astigmatism.) Technolas 217 may be approved, giving us another laser option, but I don't think we'll have phakic IOLs until 2002 or custom ablation before 2001.

This year will be a time to settle down and look at the available technology – to get our perspective and make sure we use current technology appropriately. Given the ranges that we're now able to treat, and the advanced technology that's already available, that's not such a bad situation to be in.

Intacs intrastromal corneal ring segments (ICRs) are now available from -1 to -3 D of spherical myopic correction. Visual acuity results have been excellent. Perhaps even more important, many patients like the potential reversibility this option offers, in case their eyes change in the future or new technology is developed. In fact, about half of my patients in this range pick Intacs over laser surgery, given the option.

Clinical studies extending the range for Intacs up to -4.5 and extending the lower range to -0.75 D are ongoing, and results so far have been excellent. However, the timing of FDA clinical approval is impossible to predict; there are too many factors that come into play.

Generally, I avoid doing primary procedures outside the FDA approved range, although I'm willing to do an enhancement if post-op recovery warrants it. This doesn't exclude many patients, because most patients outside the approved ranges can be treated in two stages. This also allows ample opportunity to gauge the effect of the first treatment and decide whether it makes sense to pursue further correction.

For hyperopia, we now have an approved range up to 4D, although some laser companies are conducting clinical studies up to 6D. I advise patients that I'll correct up to 4D, and if they have residual hyperopia, we can think about an enhancement down the road.

The approved range for treating astigmatism with a laser is up to 5D, but that's only because that's as high as the investigators went in the trials. We don't really know what the upper limit is.

Nevertheless, I advise patients that I'll only treat up to 5D. Then I'll evaluate how well they do post-operatively and see whether we should consider an enhancement (laser or astigmatic keratotomy) to correct any remaining astigmatism. (I believe that most doctors would find this to be an acceptable strategy.)

Amidst all of the current hype about new technology, I think it's important to keep these forthcoming advances in perspective. How much will our patients really gain from them? Patients in the approved ranges may recover faster or end up with slightly better quality of vision. But the reality is that these new technologies won't have much of an impact on the majority of patients.

If somebody can see 20/20 or 20/15 with a spectacle correction, they should have a shot at 20/20 vision – or better – without using a customized laser. We all look forward to the day when we'll take patients beyond how well they see with
glasses and contact lenses, but getting there will take a lot of work, a lot of development and more expensive technology.

The bottom line? I think most patients and doctors should be pretty satisfied with what's available right now.

Dr. Durrie, with more than 19 years of experience in refractive surgery, has participated as an investigator and medical monitor in various excimer laser clinical trials. He was the principal investigator for the Keravision Intacs and phakic IOL implant studies. He trains surgeons from around the world to use new surgical devices and techniques.