SAN JOSE MERCURY NEWS

SURGEONS CLAIM READING GLASSES ARE NEARLY PASSE

Tuesday, May 23, 2000
Section: Silicon Valley Life
Edition: Morning Final
Page: 1E
BY JULIE SEVRENS, Mercury News
Memo: HEALTH & FITNESS

IT WAS a bright, sunny day in Monterrey, Mexico, when Dr. Stephan Plager underwent one of the most controversial procedures in optometry.

Mildly sedated and lying on the operating table, he spent two hours earlier this month having four acrylic implants inserted into each of his eyes. The tiny rice-shaped pieces would cause his eyes to bleed initially and would leave him painfully sensitive to the glare of the Mexico sun. They could trigger an infection, lead to blindness, or result in no improvements to his vision at all.

But it was believed that, should the operation prove to be a success, the Santa Cruz ophthalmologist would never need reading glasses again. His aging eyes would see close objects as well as they did 30 years earlier. Presbyopia -- the age-related inability to focus the eye on near objects -- would no longer be a hindrance.

''It's so exciting,'' says Plager, who had grown accustomed to keeping extra pairs of spectacles in his boat, his car, his home and his office. ''It's a nuisance to carry around reading glasses all the time.''

And so it was that Plager found himself crossing the Mexican border so he could undergo the experimental procedure -- not yet approved for use in the United States -- which skeptics have called unsafe and ineffective.

The assistant clinical professor of ophthalmology at Stanford University was gambling that the operation could help him -- and possibly millions ofothers.

''Think of all the baby boomers who are out there who are getting into their 50s who get tired of wearing their (reading) glasses,'' says Plager. ''The market for this is so enormous.''

Indeed, presbyopia affects 100 percent of the population after the age of 40 or 50. An estimated 76 million baby boomers are -- or are about to be -- experiencing the symptoms of presbyopia, which include headaches, eye fatigue and blurred vision while reading.

But even younger generations aren't that far behind. Over time, everyone begins to experience a decrease in elasticity in the lens of the eye. And as a result, over time everyone ends up having problems reading.

''The numbers are astronomical. There are 50,000 people becoming presbyopic every month,'' says Dr. Ronald Schachar, president of the Dallas-based Presby Corp, who pioneered what has been termed ''Surgical Reversal of Presbyopia.''

For decades, however, sufferers have had few satisfactory options. Bifocals, reading glasses and specialized contact lenses have made up the majority of the offerings. So ophthalmologists say it would be an understatement to call the demand for -- and potential financial windfall from -- an effective surgical technique for the eye condition ''high.''

''Presbyopia,'' explains Schachar, ''is the Holy Grail.''

Yet while Schachar and his backers would have you believe such a prized technique has now been found, many scientists believe such technology is still elusive.


Studies lacking

Independent scientific research to support Schachar's claims is meager. There are no long-term, large-scale studies of the procedure. The first patients it was tested on -- not even a decade ago -- were given prototypical implants that have since been redesigned. And Food and Drug Administration-approved research trials are just now set to get under way.

Although there may be anecdotal evidence to suggest that Schachar's method helps aging eyes to read again, many experts in the field just aren't buying it.

''This is a very shady deal,'' says Dr. Steven Mathews, a researcher in Lubbock, Texas, who measured the benefits experienced by several patients who underwent the surgery.

''I measured nothing. There was no effect,'' Mathews says. ''People need to be careful.''

Schachar, in fact, shocked the ophthalmology world when he offered his own unique hypothesis about what causes presbyopia. In contradiction to the traditional theory that had been accepted for nearly 150 years, Schachar's concept has engaged researchers in a sort of ''Is the world round or flat?'' debate.

Scientists have long thought that presbyopia is caused by a hardening of the lens of the eye. The more the lens can be ''bent'' by tiny muscles in the eye, the better it is able to focus on close objects. But as the lens becomes less flexible, it doesn't bend as well, and the distance at which we can see clearly gets greater.

Schachar, however, believes that the problem is not with a hardening of the lens but with what he calls the expansion of the lens. Gradually it grows -- like an onion putting on more layers -- so that ultimately the muscles in the eye don't have as much room or strength to focus the lens, he says. By embedding four plastic implants in the white of the eye, the procedure gives underlying muscles room to stretch and can thus exert more force on the lens, he believes.

''This is sort of a revolution,'' Schachar says. ''We've been able to reverse presbyopia for the first time in history.''


Reversals questioned

Some researchers concede it's possible patients may be able to read without glasses after undergoing the procedure. But they find fault with Schachar's belief that the surgery is in any way reversing presbyopia. What is more likely, they argue, is that the implants somehow cause an aberration in the eye -- perhaps a curvature of the cornea -- that results in the patient beingable to see both near and far to some extent. It might be that the eye becomes its own bifocal.

''What I can say with a fair amount of certainty is his surgery does not do what he thinks it does,'' says Mathews. ''That doesn't say it doesn't help people read.''

Of course, if the operation restores near vision in any way, it doesn't really matter whether it reverses presbyopia or just offers a visual improvement. For many patients, any improvement would be better than nothing, Mathews concedes.

Six U.S. studies -- including one at Stanford University -- are set to test whether the surgery is safe and effective. But some of the patients who have already undergone the procedure -- about 175 people have done so in 26 other countries -- have nothing but good to say about it.

''It's like somebody's taken 15, 20 years off my life,'' says Plager, 60, who could read a newspaper without glasses just minutes after his surgery. Within days, he was back at work operating on his own patients. Now, two weeks into his recovery, he feels nothing but liberated, he says.

''I haven't needed glasses since the surgery.''

But if the procedure ever is approved by the Food and Drug Administration, many aging baby boomers looking to have a similar success story may be disappointed.

''It isn't for everyone. There are some people who are not good candidates,'' stresses Dr. F. Hampton Roy, a respected Arkansas eye doctor and author who in February became the first ophthalmologist in the world to have the surgery performed on his own eye.

The surgery likely would not be recommended for anyone suffering from severe hypertension, lupus, rheumatoid arthritis or a host of other medical conditions. And anyone considering the procedure would have to weigh the risks along with any potential benefits. Any surgical intervention can have complications.

''The irony of all of this is presbyopia can be compensated for optically so easily through spectacle lenses -- or bifocal spectacle lenses or just reading glasses,'' says Adrian Glasser, an assistant professor in the College of Optometry at the University of Houston. ''It doesn't require incision. It doesn't have the potential for infection of the eye. And it's been used for hundreds of years.''

That may be true, but many in the field believe consumers would flock to anything -- however marginal -- that would promise them a more permanent solution for their aging eyes.



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