Cataract care with bonus

THE BALTIMORE SUN

You just have to keep your eye very still," Dr. Sheri Rowen says to the patient lying face-up on the gurney next to her.

Rowen, director of the Eye and Cosmetic Surgery Center at Mercy Medical Center, is seated at a viewing microscope inside a third-floor operating room.

She has zoomed in on the left eye of 68-year-old Lydia Dixon, who is about to become the beneficiary of what Rowen calls "the revolution of our time in my field," words not normally associated with the removal of a cataract.

The procedure is being shown on a video monitor. Dixon's eye -- the pupil colored bright orange by reflected light, making the on-screen image look like a close-up of Mars -- has just been doused with topical drops.

"This is how we numb it," says Rowen.

Likewise, the federal government is going to take some of the sting out of Dixon's medical bill, which can be expected to run between $4,500 and $5,500.

Last month, Medicare agreed to cover the base price -- about $2,000 per eye -- of a new generation of implant lenses recently approved for cataract surgery by the Food and Drug Administration. These new lenses offer a bonus: They have a variable range of focus, meaning they also cure presbyopia, the medical term for the human eye's inability after about age 45 to read fine print.

"Glasses drive me nuts," said Dixon, a Goldsboro, Md., resident and avid reader, shortly before she was wheeled into the operating room.

Her cataracts were diagnosed six months ago, but she decided to put up with the resulting blurred vision until Medicare's revised regulations kicked in.

The old rules for cataract surgery only allowed the government to pay for a basic replacement lens, since restoring everyday vision is considered a medical necessity. For more sophisticated lenses, patients had to pay in full. Thanks to the revised guidelines, however, Dixon and others now have the choice of upgrading -- and throwing away their reading glasses -- providing they pay the price difference.

"I didn't like having to pay, but if it's your eyes, that's worth it," says Joan Helm, 76, of Ocean City, a Medicare-eligible patient who preceded Dixon into the operating room and who also opted to have the variable-focus replacement lenses.

Cataract surgery is reportedly the most common surgery in the United States, with more than 1 million procedures performed each year, according to a 2002 survey by Prevent Blindness America. In addition to offering patients enhanced vision, a several-thousand-dollar bump in the fee opens a new revenue door for physicians, as well as the three variable-focus lens manufacturers that have received FDA approval.

The technology also has the potential to create a much bigger market if people without cataracts start turning to high-tech implant lenses purely for presbyopia relief.

The FDA has not yet approved the new lenses for that purpose, but the restriction doesn't prevent doctors from performing that kind of surgery. They just can't openly market implant lenses as an antidote to reading glasses.

Rowen has done more than 100 of the variable-focus implants, including some on patients who had no signs of cataracts. She believes this is a rare opportunity to reverse the aging process.

"It has been our Holy Grail quest my whole career," she says, "because presbyopia affects 100 percent of the population."

Her patients are usually on and off the operating table within a half hour. Dixon is getting a Crystalens implant by Eyeonics Inc., a California-based company that in November 2003 became the first FDA-approved manufacturer of a variable-focus lens.

Rowen begins by making a cut in the protective sac-like capsule that surrounds the natural corneal lens inside Dixon's eye, now hazy with cataract damage. Using micro-instruments, she pulverizes the lens, vacuums out the debris, then inserts the Crystalens. It's a process roughly analogous to switching photographs in a picture frame.

The silicon Crystalens is shaped like a miniature, transparent wristwatch: the round lens (slightly smaller than a hard contact lens) has two hinged brackets that protrude from opposite sides. Those brackets are held in place by tension and serve to connect the artificial lens to the tiny, peripheral muscles on the interior walls of the eye.

This allows the muscles to control the new lens much like they did the eye's original lens, moving it backward and forward as Dixon focuses on objects at various distances.

Two other manufacturers, Alcon and Advanced Medical Optics, entered the market this spring with their FDA-approved version of variable-focus lenses; respectively called ReSTOR and ReZoom. Other companies are working on similar lenses.

But there's little chance, says Rowen, of implant-lens storefront operations popping up in the future, as happened when Lasik eye surgery became available to the general public. This type of surgery, she explains, is more costly, more patient-specific and more delicate.

That's exactly what gives Dr. Walter Stark, director of cornea and cataract services at the Johns Hopkins Wilmer Eye Institute, pause. He's intrigued by the technology's potential, but adds, "the thing I'm negative about is that these entrepreneurs might hype and promote something that may not be in the best interests of their patient."

He recalls the claims made about 10 years ago for radial keratotomy, a surgical procedure for nearsightedness that fell out of favor when long-term post-operative problems began to surface.

Stark has heard reports of variable-focus lenses causing nighttime glare, halos and other complications. A few patients with those symptoms have come to Wilmer seeking remedial help.

He's therefore taking a conservative approach and does not recommend the implants as a treatment for presbyopia alone.

Rowen, who tracked Crystalens through its development phases and was the first Baltimore surgeon trained to perform the procedure, says post-operative glare and other problems were a concern only in the early stages of FDA clinical trials.

Complication rates since then are within the normal range for eye surgery, she says, and, in her personal practice, she adds, virtually nonexistent.

"I think that's the reason we have clinical trials," says Dr. Stephen Dell, an Austin, Texas, eye surgeon who was one of the FDA's 17 designated clinical investigators testing Crystalens and other variable-focus lenses.

Dell has done about 350 implant surgeries during the past four years and has seen no long-term complications.

Lydia Dixon is not expecting her experience to be any different. Two days after her operation she can read fine print with her left eye -- and has scheduled a second surgery with Rowen to do the right one.

Says Dixon, "I can't wait."

Weighing Implants

The focusing lens inside the eye begins to harden and lose flexibility with age, which is why, sooner or later, everyone requires glasses for close-up reading, a condition known as presbyopia.

Often the lenses also become corrupted by cataracts, which cause cloudy vision.

Americans age 65 and older are eligible for Medicare health coverage for cataracts. They must have an existing cataract condition in order to qualify for partial reimbursement of the cost of newly developed, variable-focus implant lenses. In general, the surgery costs between $9,000 and $11,000 for both eyes, and patients pay at least $4,000 of that out of pocket.

For more information, go to the Food and Drug Administration's Web site (www.fda.gov) and search for "cataract implant lenses."

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