June 20, 2001 — Sandi Dexter began wearing prescription eyeglasses when she was 5 years old and was fed up with glasses and contacts when she decided to have laser surgery last year. But like thousands of people with severe astigmatism, or irregularities in the shape of the cornea, the 40-year-old Portage, Wis., resident was told she was not a good candidate for the surgery.

Instead, Dexter underwent an experimental procedure to implant permanent corrective lenses in both eyes, and she now has 20/20 vision. The procedure, known as Phakic intraocular lens, or IOL, implantation, has been routinely performed in Europe for more than a decade, and FDA approval is expected in the U.S. within a year or two.

“It is like a tiny miracle to get up every morning and be able to see my bedroom wallpaper or what the weather is like outside without having to put on my glasses,” Dexter tells WebMD. “It is just unbelievable.”

Unlike laser or LASIK surgery, Phakic IOLs do not improve vision by changing the shape of the cornea. Surgeons cut a small slit in the eye and insert a lens that unfolds and corrects vision. The surgery appears to work better than LASIK in people who are severely nearsighted or farsighted, and unlike LASIK, the procedure is easily reversible if there is a problem.

Madison, Wis. ophthalmologist John Bukich, MD, who performed Dexter’s surgery, monitors the clinical trials of STAAR Surgical Corporation’s implantable contact lens, one of the three main IOLs under consideration for FDA approval. He says the potential market for IOL implantation within the U.S. could far exceed the roughly six million people with severe astigmatism who, like Dexter, are not good candidates for LASIK. Bukich also serves as a consultant for STAAR.

“If the risk of complications for [IOL] surgery turn out to be lower, it may very well replace LASIK,” Bukich tells WebMD. “But you have to remember that on any given day in the U.S. there are roughly 18,000 LASIK procedures performed, and that is the cumulative experience with this implantable contact lens. The fact that it works is beyond dispute. The issue is whether there are problems and are they manageable.”

Early versions of Phakic IOLs, which came into direct contact with the lens of the eye, occasionally caused the formation of cataracts — the progressive clouding of the lens that can lead to blindness if not treated by surgery. But Bukich says cataracts have not been an issue in the trials evaluating the newer lenses.

Ophthalmologist George Waring III, a founder of the Emory Vision Center in Atlanta, says he has implanted 100 Phakic IOLs since the early 1990s and has seen few problems among his patients. He notes that the scientific literature, although preliminary, does suggest that complications occur less frequently among patients treated with intraocular lenses than with laser surgery.

Because IOL surgery requires local anesthesia and an operating room, the patient may view the procedure as more complex than LASIK.

It takes about half an hour to implant a lens vs. roughly 10 minutes to perform laser surgery on an eye, Waring says, and the cost of the surgery is about $1,000 more per eye.

“While the surgery may seem more complex to the patient, this is still a relatively simple procedure,” he tells WebMD. “It is similar to cataract surgery, but is a lot easier, because with cataracts you must remove the patient’s lens.”