Clear lens exchange (CLE) has been the alternative for patients who have a high refractive error and are not candidates for LASIK. But phakic IOLs - implantable refractive lenses - will be here as soon as late fall or early winter, and could change your facility's refractive surgery lineup.

David C. Brown, MD, an ophthalmologist here at the Eye Centers of Florida in Fort Myers, has been implanting phakic IOLs at our facility as part of FDA trials for about five years now, and because of this, we've had the opportunity to develop a plan for adding the procedure to our caseload. Here, I'll tell you what you need to know to formulate a plan for your facility.

A reversible alternative
"Phakic IOLs are going to be very important to refractive surgery," says Dr. Brown, "because early indications show the implant-able lenses result in better vision than other types of refractive correction."

This procedure is good for people who still have accommodation abilities; if they don't, you'd probably be better off doing CLE.

Phakic IOLs can treat patients outside the range for LASIK, "namely 10 diop-ters of nearsightedness up to 20 diopters of nearsightedness," says Charles Post Jr., MD, of Plymouth Laser and Surgical Center in Plymouth, Mass. "We'll now have a safe treatment for those who couldn't be treated [by laser]. And it'll be available in lower powers - down to 1 or 2 diopters."

So you'll be able to market this service as an alternative for patients who aren't candidates for LASIK or CLE.

Some might be scared away when you tell them the procedure is actual surgery, complete with IVs and sedation. But the fact that it's reversible makes it much more appealing to many.

For surgeons, an easy transition
Implanting phakic IOLs is something your cataract surgeons can do with a little training on the specifics of the procedure (see "Phakic IOL Training in Latin America").

"It will open up the possibility of doing refractive surgery to a large number of surgeons who have not committed to the expense and training of LASIK," says Dr. Post. "Surgeons already doing temporal clear corneal surgery will find this to be an easy transition."

For the surgeon, the procedure is probably a little tougher skill-wise than cataract surgery. After he makes the incision, he has to inject the lens into a very small space; if the phakic IOL touches the crystalline lens, the patient will develop a cataract.

The good news: Except for the phacoemulsification machine, the instrumentation is the same. And because phaco isn't part of the procedure, the time in the OR is not as long.

Surgical setting and scheduling
It seems this procedure is best suited to office-based and freestanding outpatient facilities. Because you won't generally have to deal with insurance or Medicare billings, you can perform the procedure at your ASC and keep the price close to LASIK's. Physicians without their own ASC may want to do phakic IOLs in the minor procedure rooms at their offices, and probably can, provided they stay in the anesthesia risk zone.

It seems that the hospital OR setting would be cost-prohibitive for patients because of the hospital fees that may be involved; a physician doesn't really have a say in determining what patients are charged.

The first thing you have to schedule your patients for is laser iridotomy, usually done the day before surgery. The physician must perform laser iridotomy on the patient so the aqueous can flow behind the lens. If the iridotomies are not done, you'll have to deal with pressure spikes. The iridotomy can be done at the time of the surgery, but most doctors like to do it ahead of time to be sure they have good openings.

You have to decide whether to schedule patients in blocks or for entire days. Patients need an intraocular pressure check two-to-four hours post-op, so we've taken to performing the phakic IOL cases early on our normal cataract days. The latest we do these surgeries is early afternoon; that way, patients come back for pressure checks before we close.

How many phakic IOL implantations can you do in a day? Well, because we're omitting the phaco stage, this procedure is quicker than cataract surgery. In fact, Dr. Brown does phakic IOL cases in less than three minutes, and total case time is less than 10 minutes. If we're really rolling back-to-back, and everyone is where they need to be, we could do 20 of these surgeries an hour between our two ORs.

Your recovery times for phakic IOL implantation should not differ from those for cataract surgery - just follow your standard of care. Our anesthesia providers give a block and 1mg to 2mg of Versed, and patients are generally out of recovery in about 30 minutes.

Naming your price
Most of your phakic IOL patients are going to be younger than Medicare age, so they'll be paying as a typical LASIK patient would: out of pocket or in payments. This demographic generally has the most disposable income, but you're still going to have to price competitively. For phakic IOL implantation to be economically viable for everyone, then, the lens manufacturers are going to have to price the lenses in such a range that the entire procedure is comparable, price-wise, to LASIK.

Here's a rundown of the estimated per-case costs that will be associated with this new phakic refractive surgery:

• The lenses will probably cost $250 to $750, but the manufacturers may end up setting prices closer to the low end.
• The anesthesia provider fee will be around $200, depending on the method.
• The facility fee for cataracts is around $800, but you're not going to be able to charge that and stay in the LASIK range. Figure $500 for your facility fee.
• Your physician fee, however, is going to have to be higher than with cataracts, because the surgeon will have to perform laser iridotomy ahead of time; plan on about $900.
• Finally, you're going to have the co-management fees for the referring optometrists, and that's probably going to be about $100 to $200.

Estimated total: $1,950 to $2,550. That's still in the range of LASIK and the range of what patients in their 20s to their 50s seem willing to pay to shed their glasses and contacts.

Evolving technology
Phakic IOL implantation is not a catchall; it depends on the amount of diopter correction needed, and LASIK technology is getting better all the time. Once the FDA approves the lenses, more solid criteria will develop regarding when you want to recommend implanting lenses versus LASIK. That said, I think the benefits of phakic IOLs far outweigh any of the risks or known potential problems - and that, like cataract-surgery lenses, phakic IOLs will get better and safer the longer they're on the market.