And reading glasses?
Happily, helping the legions of unhappy boomers with their presbyopia — "the last frontier" of ophthalmology — has grabbed the attention of researchers and their funding sources, says Dr. Tueng Shen, director of the Refractive Surgery Center at the University of Washington Medical Center.
"The boomers are at our doorsteps all the time," she says. "You want to offer them something to make them satisfied. This is really the exciting time for baby boomers."
There is good news on the aging-eye front, and Shen believes there likely will be much more to come in the next decade.
New procedure
In March, the FDA approved a procedure for presbyopia — so far, the only one marketed specifically for this age-related change. The technique, called conductive keratoplasty, or CK, uses radio waves to reshape the cornea without the cutting of laser-based surgery.
Using a tiny probe applied in a circular pattern, the eye surgeon heats small areas of collagen, which then shrink to sort of cinch up the eye, bringing back the curve and the focus on close objects. The surgery is done in about three minutes and has an impressive safety record, experts say.
The procedure, which most often is done only on one eye at a cost of about $1,500, was developed by Refractec, a California startup company, and is considered a "temporary" fix, because there is some regression. It works through a principle called "blended vision," similar to "monovision," which sets one eye for close work and leaves the other for distance.
Other products in the pipeline also may benefit boomers with presbyopia. They include a hinged lens (already approved, though not tested on boomer-age patients) and implantable contact lenses that can be changed when your eyesight does (not yet approved, but coming along, Shen says). Although insurance most likely won't cover these procedures, boomers, as a group, already pay considerable out-of-pocket expenses for other "cosmetic" or "lifestyle" procedures.
Early converts
Bob Canterbury, 55, of Camano Island, didn't really need to see much detail in his former profession: he was a chainsaw carver, sculpting blocks of ice into art.
About five years ago, he switched to a job that required him to work on computers and found the put-on, take-off routine of reading glasses irritating. He was wearing 21.50 reading glasses late last year when he took advantage of a promotional offer by Dr. Kent Leavitt of Bellevue Lasik-Cornea Consultants.
He had NearVision CK, the proprietary name for conductive keratoplasty, on both eyes, one set up more for distance, the other more for close-up. He experienced some "scratchy eye" feeling for a few days, but says "it wasn't bad at all."
Canterbury is one of about 75 million boomers, that grumpily aging cohort born between 1946 and 1964. This year, the youngest turn 40, usually the early side of presbyopia's onset.
As a group, boomers have already signaled their willingness to undergo eye surgery, making up a good chunk of the 3 million patients who have had Lasik surgery, a laser-based technique that cuts a flap in the cornea and reshapes tissue underneath, now done to correct both nearsightedness and farsightedness. The latter is done through "monovision," correcting one eye for close vision, leaving the other for distance.
There is at least one trial under way for a new laser-based procedure for presbyopia, and researchers have been hard at work to develop alternatives.
Conductive keratoplasty is not a new procedure: The FDA approved it in April 2002 to treat low to moderate hyperopia, another type of farsightedness that isn't caused by age. Researchers reported that CK achieved about the same results as laser-based procedures, and it had a lower rate of complications.
Results of trials for presbyopia were impressive as well: A year after CK, 98 percent of patients previously needing 31 to 42.25 correction could read newspaper-sized print without glasses using the eye that was treated, and 87 percent could see 20/20 and read phonebook-sized print, Refractec researchers said in their application to the FDA. They reported no serious or sight-threatening complications.
Eye experts say they like the idea of not messing around with the part of the cornea you see through; CK works on the periphery. "With Lasik, you treat right in the middle, so if something goes wrong with the flap, you could damage your vision," says Shen, who does Lasik but not CK. She says CK "is very, very safe. It's pretty hard to mess it up."
Leavitt, the Bellevue eye surgeon, says CK works better for presbyopia because it doesn't change the distance vision so much in the eye that's set for close work — thus, the "blended" vision.
It's not the perfect solution to everyone's presbyopia, though. Some people can't get used to having one eye focused for close work and the other for distance, although most people say their brains adjust quickly to the change.
Also: CK is being marketed as a "temporary" procedure, because over time, the presbyopia returns. Some experts believe that cells called "keratocytes" naturally try to clean up abnormal collagen, "nibbling" away at the benefits.
Leavitt believes it's the progression of the underlying condition that causes some regression. He tells patients they'll likely have to have the procedure repeated in the future. But how long before they'll need a repeat isn't yet clear because there's not a long track record.
Typically, Leavitt said, people who have the procedure will notice an improvement right away, and then their vision will get even better for a few weeks. But ultimately, it's "setting the clock back," he says, not making the problem disappear forever. Think of it as similar to skin resurfacing, he says: You won't look like you're 20 forever, but it'll give you five or 10 years of extra time.
"We're working on improving function," he says. "The goal is that they be able to do most of the activities of daily life — read a paper, read a menu, dial a cellphone. It doesn't make you like you're 20. It takes you back to the point where you just barely started noticing a need for reading glasses."
The best candidates
The ideal candidates for CK, he says, are people with 20/20 distance vision but who need reading glasses for close work.
That was Randy Belieu, 43. When he was 40, "I started noticing the printing on the pages was fuzzy and my arms weren't long enough," he recalled. He tried reading glasses, but since he'd never worn glasses, found keeping track of them to be a pain.
"I bought eight pairs, left them all over. I'd leave them on, then I couldn't see far away." But he says he just couldn't bear to put a little chain around his neck. "To me, that's when I'm old."
A nurse at a Seattle hospital, Belieu found it more than irritating to be always reaching for his glasses. "When I was out on the floor, you don't want to be pulling them out of your pocket all the time, because they can become contaminated. They'd fall out of my pocket. ... It was just really not good for me."
He only needed 51 reading glasses, the weakest ones, when he, too, received the special offer from Leavitt, who did the procedure free for the first 20 people who qualified.
"I was very worried at first," Belieu recalls. "It's your eyesight."
Leavitt answered all his questions well, Belieu said, and he went ahead with the procedure a few months ago on one eye.
Now, he's happy to be able to read the tiny print on medications without glasses. He knows the improvement won't last forever, but even so, says Belieu: "I would do it again in a heartbeat."
Canterbury's sister, Pat Larson, 59, who was up to 3.25 readers, had the procedure done by Leavitt on one eye. After a few months, she had to go for some "tweaking," she called it, because she noticed she was having to wear her readers again. Her eyes are still much better than before, she said, and she's been "singing the praises of this treatment."
She didn't have trouble getting used to blended/monovision effect, because she was already using one contact lens in her weaker eye for reading, while the other eye needed no help for distance. Larson also had the procedure done for free. If she'd had to pay for it, she says, she'd likely still be using her contacts.
Other remedies in the pipeline
Late last year, the FDA approved a new surgically implantable "hinged" lens called crystalens that appears to significantly improve both far and close vision. It was tested on and approved for older patients with cataracts, but eye surgeons say they plan to use it for presbyopes, as well.
The artificial, implantable lens part isn't new. Eye surgeons have been implanting synthetic lenses in cataract patients for 20-plus years.
Those lenses, though, were fixed on a set focus point.
Crystalens' hinges allow eye muscles to squish and pull the lens to change focus, much the way they do with a young and flexible natural lens. The lens, marketed by a California company called eyeonics Inc., is implanted in 10 to 20 minutes in a procedure similar to lens implants now used for patients with cataracts. It's expensive — an estimated $5,000 per eye — but ophthalmologists like the idea of a one-time, do-everything fix, although it's not yet clear how long the hinge will last. The company's ads promise that crystalens will "give you the quality of vision you enjoyed when you were younger."
Ophthalmologists are excited about the lens' promise, but there's controversy over whether crystalens ought to be used on patients with normal age-related vision problems, rather than only on patients with cataracts. Leavitt and Shen, who are both undergoing training to install the lens, say they soon plan to use the lens for both types of patients.
Clinical trials showed good safety in older patients (average age was 70), but the FDA noted the lack of evidence of safety when used in patients younger than 50, and there's no long-term safety data. As with any implant, there are dangers in introducing a foreign object into a person, including infection and bleeding. There's also a danger that the retina could detach, causing blindness, although this didn't happen in the trials.
Crystalens, says Shen, marks the way of the future. "This will be the beginning of the next wave — a permanent solution."
For now, Leavitt predicts, patients likely will be cautious about this procedure.
"It involves removing your natural lens, and putting this one back in," he says. "It's intra-ocular surgery; there's a fear factor for most people."
Results are "quite phenomenal," he says: According to the company, two-year clinical-study results showed that 92 percent of the people enrolled in the study who'd had both eyes done could see 20/25 or better at distance, 96 percent could see 20/20 at arm's length and 73 percent could see 20/25 focused on near objects without glasses or contact lenses.
What should you do?
Shen, the UW refractive-surgery center director, urges a "wait and see" stance toward new devices and procedures.
For more information
• Conductive keratoplasty: The "MyClearVision" Web site, produced by Refractec: www.myclearvision.com. This Web site, like the one below, is produced by a for-profit company marketing an expensive device. Use the information as a starting point in your education process.
• For FDA approval information: www.fda.gov/default.htm (search for aav0001 and look for 2004 "safety and effectiveness" reports).
• Crystalens: www.crystalens.com.
• A negative view of refractive surgery: www.lasikinfocenter.net. Take this, too, with a grain of salt, but it contains good cautionary tales and advice, such as checking out your doctor, as well as links to source materials such as Ophthalmology, the journal of the American Academy of Ophthalmology.
• Tough questions for your doctor: www.usaeyes.org. Be aware that this group itself has been criticized as self-serving (see lasikinfocenter.net). Nevertheless, the questions and answers will help educate you.
• A University of Washington TV production explaining some basics about refractive surgery: www.uwtv.org/programs
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"I stay very conservative for any type of new procedure. I just say, 'This is not something that will solve all your vision problems.' You can't expect to have perfect vision up close and for distance at age 55."
People who are 55 or 60 should try to "hang on for a little longer," she says. "In general, be cautious. The longer you wait, the better off you are."
Multiple eye surgeries may be better financially for eye surgeons, but each one has risks for patients.
Shen says she considers CK "very safe," but adds: "I feel uncomfortable, for patients coming in for a procedure, knowing that the long-term results are going to change, that vision is going to slowly deteriorate."
Leavitt says there's room for four concentric rings of tightening around the outside of the cornea, so repeat CKs can be done for most patients, who typically use only one or two in the first procedure. But both he and Shen note there isn't really a track record to say for certain that multiple procedures will be safe.
"I'm more concerned about repeat CKs in the future," Shen says. "Nobody knows."
As with Lasik, it's also important that patients who shouldn't qualify for the procedure are identified and turned away, Shen says. New procedures, which generate a lot of initial enthusiasm, have "a mighty potential for misuse."
Her goal, she says, is to be able to offer patients a "permanent solution." She believes the intraocular-lens designs, perhaps including crystalens, will prove to be the ticket for boomers.
For now, she says, patients should ask lots of questions.
"When patients come in and are very afraid to ask questions, that's the patient I tend to turn down," she says. They're more likely to be unhappy with the outcome, while patients who ask questions are more realistic, she says.
"As with anything in medicine, there is no perfect solution, no perfect results. The patient needs to know that," Shen says. "Get the facts, so you feel like you understand it, before you make a decision." |
