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New focus in vision treatment

THE BALTIMORE SUN

When Cheryl Flood's husband had laser eye surgery to correct poor vision a few years ago, she was more than envious. "I was downright resentful," said the 40-year-old mother of two. "He qualified for the surgery, but I didn't. It seemed unfair."

Like many people, Flood wasn't a good candidate for conventional LASIK or other laser procedures because of corneal irregularities.

Still, she persevered in her quest for a glasses-free existence. She called her doctor, Sheri Rowen, every few months for nearly three years. She plunked money into her tax-free health care spending account in the hopes that a new technology would come along.

Eventually it did.

Two days ago, Flood was one of the first people in the United States to receive newly approved implantable lenses in a surgery by Rowen at Mercy Medical Center in Baltimore.

A second patient, with severe nearsightedness not treatable by laser procedures, will have the same surgery at the Johns Hopkins Wilmer Eye Institute later this month, performed Dr. Terrence O'Brien, a principal investigator during the lens' U.S. clinical trial.

The synthetic lens, widely used in Europe for more than a decade, was approved by the Food and Drug Administration in September. It will be marketed under the brand name Verisyse by Advanced Medical Optical Inc. of Santa Ana, Calif. A second lens by another company is expected on the market in the spring.

"These implantable lenses are the wave of the future," said Rowen. "They have the ability to correct vision with exact precision without altering the shape of the cornea." And unlike laser procedures, which do alter the shape of the cornea, implantable lenses are permanent, although they can be removed if there are problems.

Flood, an energetic woman with auburn hair and bright blue eyes, arrived at Mercy Medical Center Wednesday morning with her sister, another LASIK patient whose vision was corrected several years ago.

"I'm excited," said Flood, whose uncorrected vision was worse than 20 / 400. "And I can't wait to get rid of these," she added, motioning to her thick glasses.

By 1 p.m., Flood had been lightly sedated and prepped for surgery on her left eye. In most eye surgeries, it's standard procedure to operate on only one eye at a time, in case there are complications. Her right eye will be done next month.

"No rock 'n' roll music," she said, joking with Rowen.

"Not while I'm operating," responded the 51-year-old surgeon.

Rowen cut the bottom of Flood's cornea, and suctioned up some blood. Then she slid surgical instruments beneath the cornea into the inner chamber of the eye.

Next, Rowen used tweezers to lift a synthetic lens from an operating table. The lens looked no different from any contact lens, except that it was slightly smaller. She then lifted the corneal tissue and placed the lens across the iris, over Flood's pupil.

In 10 minutes, the lens was in place. Rowen lifted muscle from the iris to anchor the lens. Then, using tweezers, she sewed the cornea back together with nylon thread thinner than a human hair.

"That should do it," she said.

Advances in treatment

The arrival of implantable lenses marks a departure from recent advances in corrective eye surgery. In the 1990s, doctors pioneered conventional LASIK treatments, which use lasers to reshape the cornea for sharper vision.

In recent years, computer and other technologies have refined the precision of laser surgery. In addition, doctors have begun using surficial ablation procedures, such as LASEK and Epi-LASIK, which correct vision by reshaping the cornea without making any incisions in the eye.

But implantable lenses piggyback on an entirely different idea that has been around since the 1940s to correct cataracts, the clouding of the natural crystalline lens that causes blindness. Doctors have long treated cataracts by replacing the eye's natural lens with a synthetic lens.

This approach saves vision, but manmade lenses are not as pliable or responsive as the eye's natural lens.

Two decades ago, researchers in the Netherlands got the idea of placing an implantable lens into the eye to correct vision without removing the natural lens.

Today, researchers are working on these lenses, called phakic lenses, to cure a host of vision problems. Eventually, doctors hope to be able to inject a substance into the eye to create lenses, which could then be altered by light rays to exact vision prescriptions. That technology is years off, Rowen said.

The Verisyse lens that Flood received is approved for use only on people who are moderately or severely nearsighted.

Market analysts estimate that roughly 20 percent of Americans have vision problems that can be corrected with surgery. Most people opt for laser procedures because they are cheaper, treat common vision problems and have proven track records.

The Verisyse manufacturer estimates that as many as 2.8 million Americans could be candidates for the implantable lens. The procedure, which is not covered by insurance, costs between $3,000 and $4,000 per eye.

Company officials said they are being selective about which doctors they will train, because the surgery is so specialized. Some doctors worry that if unskilled practitioners attempt the procedure they could run into complications and sour the public on the emerging technology.

"This is an exciting first step," said O'Brien of Hopkins, who performed a handful of lens implants during the clinical trials. "But this is in no way like [putting in] a contact lens. We are operating within the eye. So we are proceeding with great caution."

"The surgery is very complex," he added, "and should be reserved for select patients with no other options."

Patients satisfied

During seven years of U.S. clinical trials, more than 1,100 patients were treated at 22 centers, according to the FDA. All patients saw 20 / 40 or better after the procedure. Ninety percent reported satisfaction. Three patients developed cataracts, but no patients developed swelling of the cornea.

Dave Harmon, president of Market Scope, the leading newsletter tracking the industry, said the implantable lens market may be smaller than laser procedures. "But for the individuals who benefit from the surgery," he added, "the lenses are nothing short of a miracle."

That may be the case for Cheryl Flood.

When the surgery was done, Flood surprised Rowen by sitting up and putting her new lens to work. Before her eye was bandaged, she could make out objects on a far shelf and count the fingers on an operating room attendant's hand.

"Wow," Flood said, "This is amazing."

Flood was to stay overnight with her sister and return Thursday for a final examination before heading back to her home in Fairfax, Va.

"The operation went great," said Rowen. "She's already on her way, and it is only going to get better."

Eye surgeries

Corrective eye surgery is an evolving field with new technologies. It is estimated that about 20 percent of Americans have vision problems that can be corrected by the surgeries outlined below.

Implantable lenses

Although the procedure has been available in Europe for more than a decade, people are just beginning to receive implantable lenses in the United States.

Phakic lenses: Lenses are implanted within the eye, between the cornea and iris, without removal of the eye's natural lens. The first approved by the FDA is the Verisyse lens. Cost: Between $3,000 and $4,000 per eye.

* Pros: The procedure does not affect the natural shape of the eye, and the operation is reversible.

* Cons: Major surgery is required. The lenses are only approved for use in moderate to severe nearsightedness.

Laser procedures

Of the 800,000 people each year who have corrective eye surgery, 98 percent have some type of laser procedure.

Conventional LASIK: About half of all people choose conventional LASIK treatments, in which doctors cut a flap in the corneal tissue and reshape the cornea with a laser. The procedure takes about 10 minutes per eye. Recovery time is several hours. Cost: About $1,600 per eye.

* Pros: Well-proven for those with problems such as mild nearsightedness, farsightedness or astigmatism.

* Cons: Procedure can cause vision problems regarding glare, shadows and halos. Can't be performed on people with thin or flat corneas.

Wavefront-guided LASIK: An advanced procedure that uses light technology to map the optical system precisely and computer technology to guide the laser to reshape the cornea. Cost: about $2,000 per eye.

* Pros: More precise than the conventional LASIK, it can be used on people with higher-order vision aberrations.

* Cons: Only reduces but doesn't always eliminate side effects such as double vision, halos and glare.

Surface ablation: These procedures include PRK (photorefractive keratectomy) or the more recently developed LASEK or Epi-LASIK. Doctors don't cut a flap in the corneal tissue. Instead, they remove the outermost corneal layer and reshape it with a laser. Recovery time is four to seven days. Cost: About $1,800 per eye.

* Pros: Doctors don't cut the corneal tissue, eliminating potential problems. People with thinner corneas are eligible.

* Cons: Less proven than conventional LASIK. Recovery time is four to seven days.

Lens exchanges

Since the 1940s, doctors have replaced the natural lens of the eye to treat cataracts, the leading cause of blindness worldwide. Through a tiny incision, doctors break up and remove the eye's natural crystalline lens and replace it with a synthetic lens. Several companies manufacture replacement lenses for cataract surgery. Cost: Approximately $3,000. This procedure is often covered by insurance.

* Pros: The procedure is considered medically necessary and is the major treatment for cataracts.

* Cons: Synthetic lenses aren't as pliable or quick to focus as the eye's natural lens.

Sources: Market Scope (www. mktsc.com) and the American Society of Cataract and Refractive Surgery (www.ascrs.org).

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