As a fledgling intern in 1971, Dr. Harry Grabow of Sarasota Cataract and Laser Institute watched, frustrated, as patient after patient lost their eyesight to cataracts. He knew that as early as 1949, a British physician named Harold Ridley had inserted an acrylic implant into the left eye of a 45-year-old woman. "But at that time, implants were not being done in the human eye," he says.
Ridley’s dream of an implantable intraocular lens languished 20 more years while technology caught up to his revolutionary vision. It wasn’t until 1975 that Grabow finally inserted his first implant, at St. Vincent’s Charity Hospital in Cleveland.
Fast forward to today, and a new vision. "The dream has always been to have an accommodative implant," says Dr. David Shoemaker of Sarasota’s Center for Sight, because age hardens the eye’s lens, robbing its ability to change and focus at different distances. An implantable lens that mimics the human eye’s ability to adjust would offer cataract patients not only the gift of sight, but of vision very close to what they enjoyed 20, 30 or even 40 years before. And this year, the first generation implants claiming to do just that hit the market with a vengeance.
Crystalens has been available in Europe for nearly five years but did not gain FDA approval here until February. Unlike traditional implants, it is made of a patented flexible silicone and features unique hinges that allow it to move with the eye muscles, effectively restoring distance, reading and near vision. "When I started [practicing], we weren’t even close to this," says Shoemaker. "Today, cataract surgery will change your life."
Just ask David Quigley. For three decades, he couldn’t find his way out of bed without his eyeglasses. Four hours after receiving the new Crystalens implant in one eye, he was watching TV-with his naked eyes. Two weeks later, the 74-year-old Sarasota retiree received his second implant. Now Quigley sees 20/20 in one eye, 20/50 in the other, and can read restaurant menus to his wife, who’d had her cataracts removed about two years earlier.
Because of experiences like Quigley’s, the manufacturer of Crystalens has begun, blanketing the airwaves with promises of restoring vision to "the clarity of youth." At press time, Center for Sight had already treated 70 people with Crystalens. Only 40 percent were cataract patients; 60 percent just wanted to see more clearly.
"If you’re severely near or farsighted, Crystalens is the way to go," says Shoemaker. In fact, he claims, "The best candidate for Crystalens is someone 55 to 60 years old, who wants to see without glasses."
Sarasota ophthalmologist Dr. Matthew Ehrlich, who, along with Grabow, participated in the clinical trials for Crystalens, see things a little differently, While he thinks Crystalens is great for cataract replacement, "I’m concerned that it’s being promoted for vision correction."
Most of the 22 patients he treated during the trial, Ehrlich says, still require some type of glasses. "I’m an advocate of clear lens surgery, and I’m not opposed to the Crystalens," he stresses. "The problem is the lens is being marketed beyond reasonable expectations."
That’s what happened to retired policeman Gary LeBlanc, who received the implants three years ago. "Originally I thought I wouldn’t have to wear glasses again at all," says the 62-year-old cataract patient. After his surgery, one eye became slightly nearsighted and the other slightly farsighted, so he still needs to wear glasses for reading and driving. (Quigley also still requires over-the-counter reading glasses to see type in dim light.)
Some doctors question how the lens will affect younger eyes as patients age, and Shoemaker acknowledges that, "Someone in their 40s with low to moderate near or farsightedness would be better off with LASIK."
LASIK is a surgical procedure that works by exposing underlying layers of the cornea to a computer-guided excimer laser that reshapes it to correct near and farsightedness. Nearly six million patients have undergone the procedure since it was first performed in 1991, including many doctors, which Ehrlich says is the true test of any ophthalmic trend. "Thousands of ophthalmologists have had LASIK," he says. "If [Crystalens] can restore the ‘vision of youth,’ why aren’t doctors doing it to themselves yet?"
LASIK has its limits. It does not restore the "zoom" vision people require to focus up close. It also causes dry eyes in most patients for up to two months after surgery or in some cases, permanently.
So far, the only complications caused by Crystalens are financial, since its biggest market consists of cataract patients. Most cataract patients are on Medicare, and Medicare doesn’t cover it-something the marketing barrage for Crystalens largely ignores.
According to Grabow, Medicare patients can receive the implant in only two ways. If their cataract doesn’t meet Medicare requirements for removal, they must sign a waiver stating they know Medicare will not pay for the procedure. If a patient’s cataract meets Medicare requirements for removal and they elect to replace it with a Crystalens, they must withdraw from Medicare altogether, then pay the full amount of the lens themselves. (After a certain period of time, they can return to Medicare.) Medicare patients who can’t afford that luxury are not even allowed to pay for it with their own personal funds.
"If Medicare ever decided to audit a doctor’s records and discovered a doctor had implanted a Crystalens on a Medicare patient [who wasn’t eligible]," says Grabow, "that doctor and the patient would both be guilty of federal Medicare fraud."
Some private insurers allow patients to pay the difference between the cost of cataract removal and the cost of Crystalens. That’s usually about $2,600 per eye, which makes it comparable to LASIK. Grabow hopes the government will eventually permit Medicare patients to pay at least a portion of the cost. "We know they allow it in other circumstances. It would put us in line with all other countries on the planet."
Until then, many patients will wind up footing the entire bill, to the tune of $5,400 per eye. Which prompts Ehrlich to ask, "Why would anyone want to pay $9,000 out of pocket for surgery when they’d still need reading glasses?"
Some candidates for the procedure want to remove earlier implants, but Ehrlich says he discourages the practice. "You can remove a lens, but it’s not something we like to do," he says. He explains that all implants are held in place by a delicate membrane that heals around them after surgery. Removing an implant can tear that membrane. The company’s own literature states that people who have already had cataract surgery are not candidates for Crystalens.
"Any time you do things to the cornea, it’s relatively permanent," adds Grabow. "Even though complication rates are below five percent, when they happen they can be sight-threatening."
Still, Shoemaker maintains, "It’s the best technology we have." And even though it didn’t give LeBlanc the vision of his youth, he says, "Before surgery, I had to wear glasses for everything. I couldn’t drive at night at all. I’m still very pleased. If someone asked if they should do it, I’d still have to say yes."
"For some people, it’s going to be great," Ehrlich agrees. "I just want to make sure patients know what they’re getting and to have some perspective and balance."
Grabow, who has been working with the lenses since 2001, calls the technology promising: "Our data on our patients was consistent with national data, that 90 percent were able to go without glasses for near and far distance vision." But, he adds, "It’s still in its infancy. In the U.S., we implant over two million lenses per year," says Grabow. "Maybe six or eight hundred of those have been Crystalens. We really don’t know how the lens is going to work to get people out of their glasses."
ON THE BRIGHT SIDE
Crystalens isn’t the only implantable lens making news. Dr. Harry Grabow of Sarasota Cataract and Laser Institute is part of another FDA trial investigating the effectiveness of the Collamer lens. It also improves near and farsightedness, but unlike Crystalens (and all other implants), the Collamer rests in front of the eyes’ natural lenses. Since it doesn’t replace the natural lens, it can be removed and replaced as your prescription changes. Plus, it can correct up to twice as much vision as LASIK.
Also new to the vision correction scene is conductive keratoplasty (CK), which works by releasing radio waves to the cornea via a probe thinner than a strand of human hair. The radio waves shrink small areas of collagen, creating a band that increases the curvature of the cornea. This allows the cornea to focus for near distance.
Since there is no cutting or removal of tissue, it can be performed in less than five minutes in a doctor’s office using only eye-drop anesthesia. Although Grabow does not perform CK, he says, "If it is done properly, then it can work well."
According to its manufacturer, more than 30,000 patients have received CK for age-related farsightedness since it was approved two years ago by the FDA. It was approved for nearsightedness in March after a subsequent study showed that 98 percent of treated patients could read magazine and newspaper-size print; 87 percent of patients could see 20/20 in the distance and read phonebook-size print.
Like LASIK, CK is typically performed on just one eye, to improve near vision without sacrificing the distance vision in the other eye. "Patients like it, but it’s not a permanent fix," says Dr. David Shoemaker of Sarasota’s Center for Sight. "It’ll buy you three to five years."