Molly Gardner sits up in her surgery bed at Mercy Medical Center and opens her eyes.
"Can you see the clock?" asks Dr. Sheri Rowen, her ophthalmologist.
"Ten after nine," the Ellicott City resident says with exuberance not usually associated with telling time.
Fifteen minutes ago, she needed glasses or contacts to see the clock. Now, after a surgical procedure called phakic IOL, in which Rowen implanted a contact lens behind Gardner's iris, her vision has improved to 20-20.
The corrective surgery procedure, currently undergoing clinical trials in the United States, is not yet available commercially. But if approved by the Food and Drug Administration, as expected, ophthalmologists say phakic IOL could become as popular as Lasik surgery.
"The quality of vision is so outstanding [with phakic IOL] that I think it will become very popular," says Rowen, who has implanted 80 lenses since her participation in the clinical trials began in 1997.
Literature for STAAR Surgical Corp., a California company that manufacturers the implantable lenses, states that phakic IOL "may represent the next generation of vision correction" and will offer "new hope for those who are not ideal candidates" for procedures such as Lasik.
Used in Europe
Unlike regular contact lenses, an implantable lens requires no upkeep and is cosmetically invisible.
Phakic IOL -- the IOL stands for intraocular lens -- has been used in Europe since the 1980s, and more than 25,000 lenses have been implanted, according to lens manufacturers. The procedure is different from Lasik surgery in several ways.
To correct nearsightedness and farsightedness, Lasik uses a laser to reshape the cornea. Phakic IOL requires no reshaping and, unlike Lasik, the procedure can be reversed if there are problems.
Phakic IOL won't necessarily be a substitute for Lasik, according to Dr. Robert Maloney, director of the Maloney Vision Institute in Los Angeles. Phakic IOL is more effective for people with extreme cases of nearsightedness and farsightedness, while Lasik is preferable for milder cases.
Maloney said phakic IOL "gives much higher quality of vision" and predicts that in five years, patients in need of higher levels of correction will choose implantable lenses over laser surgery.
Several companies that manufacture implantable lenses are taking part in the American clinical trials, including Ophtec U.S.A. Inc., which manufactures the Artisan lens, and STAAR, which manufactures ICL (implantable contact lens).
Artisan lenses have been available overseas since 1982 and have been implanted in about 15,000 eyes, according to Rick McCarley, president and CEO of Ophtec. ICL has been available overseas for a little more than seven years and about 12,000 lenses have been implanted overseas, a STAAR spokeswoman says.
The phakic IOL procedure begins with a few drops of anesthesia to the eye. With STAAR's ICL, the lenses Rowen uses, a 3-millimeter incision is made in the cornea. The implantable lens is then inserted behind the iris and in front of the eye's natural lens (in some procedures, the lens is placed in front of the iris). The procedure does not change the color of the eye, and no stitches are required.
As yet, there is no timetable for FDA approval or when the procedure could become commercially available. Lens manufacturers and ophthalmologists are not sure what phakic IOL will cost, either, but prices likely would be in the $3,000 to $5,000 range for both eyes, which is similar to Lasik surgery.
Some doctors are urging caution about the new procedure.
"You have to put things in perspective," said Dr. Ernest Kornmehl, medical director at the center for Laser Vision Correction at Harvard University. "Implants can look good for the first few years and then destroy the eye."
Kornmehl has seen problems such as corneal swelling and cataract formation. Maloney said he has also encountered minor problems with inflammation.
Surgery as an option
Despite side effects associated with Lasik, that surgery became wildly popular in the '90s. Lasik made corrective surgery available to the masses, rendering older surgical procedures such as PRK (photorefractive keratectomy) practically extinct.
In 1992, according to Maloney, only five surgeons were performing Lasik in the United States. By 1997, 25 percent of all corrective eye surgeries were Lasik. Last year, Lasik accounted for 75 percent of all corrective surgeries -- just under a million procedures.
Phakic IOL surgery is more complex than Lasik, Maloney says, because it involves an anesthesiologist and a surgery center. Still, he added, "it's painless."
Molly Gardner, 31, and Dianne Van Rossum, 44, from Eastern Baltimore County, who both had the surgery performed the same day, agree the procedure was painless.
No bandages were necessary, and the only outward signs of surgery were dilated pupils and redness, which are temporary. And the lens does not need to be replaced as the patient ages, Rowen adds.
Van Rossum says she's going to throw out her contacts. She won't need a restricted driver's license. She sees color more vividly than ever before.
"People start walking around in wonderment," Rowen says. "It's really clear vision right away. It's a happy surgery."
A history of eye surgery
Corrective vision surgery had been around long before Lasik became the Gap of modern surgery. Here's a look at advances made since the 1950s:
* 1950s: Radiokeratotomy, or RK . Radial slits are made in the inside layer of the cornea to cause the eye to reshape itself.
* 1960s: Keratimileusis. A layer shaved from the cornea is frozen, reshaped and later reattached to the cornea.
* 1970s: Modern radiokeratotomy. Slits are made on the outer part of the cornea to cause the eye to reshape itself.
* 1980s: Lasers are introduced
* Early to mid-1990s: Photorefractive keratectomy, or PRK. A laser is used to sculpt the cornea.
* Late 1990s: Lasik (laser-in-situ keratimileusis). Like PRK, except the outer layer of the cornea is peeled back as the laser is used to carve a new shape under the cornea. Then the flap is replaced, conforming to the cornea's new shape. This accelerates the healing process and decreases pain.
* Late 1990s: Phakic IOL. No lasers. A contact lens is surgically implanted either in front of or behind the iris. This procedure does not involve reshaping the eye.
-- Tamara Ikenberg