Eyeing a new way to fix vision

By Marcie Miller

Herald Writer

ARLINGTON — While most people go to Mexico for better scenery, an Arlington eye doctor takes patients there just to see better.

Dr. R. Lee Harman, president and medical director of Cascade Regional Eye Center in Arlington, is one of a handful of eye surgeons in the United States who takes patients to Mexico for an experimental procedure to reverse presbyopia.

The goal: getting rid of reading glasses.

According to the American Academy of Ophthalmology, presbyopia affects virtually everyone over 40. Symptoms include "fuzzy" vision up close, and headaches or eye fatigue from reading. Benjamin Franklin-type reading glasses become a fact of life.

But why go all the way to Mexico for a simple surgical procedure?

Partly because the trip includes a three-day stay at a five-star hotel far from the gray Northwest — but mostly because the surgery is not legal here.

Harman said although the eye surgery known as "scleral expansion band surgery" is done worldwide, it is still undergoing clinical trials in the United States in a bid to win Food and Drug Administration approval.

While Harman is enthusiastic about the experimental procedure, it is not without its detractors. Dr. Steven Wilson, professor and chairman of the department of ophthalmology at the University of Washington in Seattle, is skeptical at best.

"We would love to have a procedure that really worked for presbyopia. But I don’t believe this is it," he said.

Ophthalmologists such as Wilson hold to German researcher Hermann von Helmholtz’s 1885 theory that the lens of an eye changes from thin to thick in focusing up close, and that with age the lens hardens and is no longer able to do that, resulting in blurred vision up close.

In 1992, Dr. Ronald Schachar of Dallas offered the countertheory that as the result of the lens growing larger with age, the fibers that move the lens into different shapes for focusing get crowded.

He theorized that like a compressed rubber band, the fibers can no longer do their job and presbyopia sets in.

Wilson said recent studies using ultrasound suggest the long-standing Helmholtz theory is right and Schachar’s theory is wrong.

But through his Dallas-based company, Presby Corp., Schachar has developed the scleral expansion band procedure to provide the tension lost with age.

It’s believed to be like a facelift for the eyes.

In the procedure, four tiny pieces of surgical grade plastic are implanted in a circle around the retina, in the sclera or "white" of the eye, where they pull the sclera away from the lens, giving the muscles room to work.

Presby Corp. markets the specialized surgical kit of instruments, the surgical technique and the patented implants to ophthalmologists in countries worldwide. The surgery is performed in Europe, Israel, South Africa, South America, Mexico, Korea, China, Taiwan, India, Malaysia and Singapore.

Stanley Thaw, executive vice president of Presby Corp., said many doctors in the United States take patients to those countries for the procedure. Several hundred scleral expansion band procedures have been done, according to Thaw.

The first of three phases of clinical trials focuses on the safety of the procedure and have been completed at six U.S. sites. A second phase will look at the procedure’s effectiveness, and a third phase will monitor the widespread use. The trials should take about two years, after which the results will be submitted to the FDA for review.

Harman said the lengthy trial period is similar to what the innovators of the now common laser eye surgery had to go through.

Although Schachar claims the procedure is relatively safe, Wilson said there are reports of serious complications, including infection, implants coming out after surgery and blindness caused by cutting the blood flow to the front of the eye from improper incisions.

Thaw said Harman is the only eye surgeon he is aware of in Washington doing the procedure.

Harman is also a recipient of scleral expansion band implants. He had the procedure done May 2000 in Monterey, Mexico.

Harman gives a disclaimer that he is a minor shareholder in Presby Corp., but said, "I didn’t do this to become a poster child for Presby Corp. I did this to see better. I’m not here to be a hero or a heretic."

Harman said the procedure corrected his eyesight from 20/25 to 20/15 for far vision, and from 20/80 to 20/20 for near vision. He estimates his "presbyopic age" was reduced 10 years, from his current 54 back to where his vision was at 44.

He uses 1.5 power reading glasses, but said he is now the "former owner of 16 pair of half-reading glasses."

Harman said the procedure won’t restore eyesight to perfect vision, but will reduce the effects of aging by about 10 years. Tests have not yet determined how long the restorative affects will last. Eyesight usually improves for the first six months, then stabilizes.

At 50, Joette Anderson of Mossyrock was a perfect candidate for the procedure.

She came to see Harman after she heard about the procedure on a television documentary and found the Arlington-based eye surgeon through the Internet.

"I was one of those people with glasses on a chain," she said. "I had reading glasses all over my house and was always looking for them. It made me crazy."

On Memorial Day weekend, Anderson accompanied Harman and others to the Vidarri Eye Clinic in Reynosa, Mexico, just across the border from Brownsville, Texas. The group left for Mexico on a Friday and returned Sunday.

"It was like going on vacation," Anderson said.

The clinic is very modern and clean, much like one in the United States, Harman said. The cost of the package, with airfare from Seattle, hotel, food and surgery, runs $6,500.

Harman said while patients could get to the clinic on their own, they need to be monitored for 24 hours before the surgery and have a follow-up visit the next day at the surgeon’s office in the United States. So the group trip makes sense, he said.

Anderson said the hour-long procedure was painless, and although she was sedated, she was awake and asking questions throughout.

She noticed an improvement in her vision right away. More than two months after the operation, she said her eyesight continues to improve.

"I would do it again in a heartbeat," she said.

Harman’s first patient was John Hovedesven of Arlington. He had the surgery done last May and has been pleased with the results. At 51, he had used reading glasses for five years, but is now lens-free. Harman has performed scleral expansion band procedures on four patients. He trained in the technique by operating on slaughtered pig eyes. One patient chose to have only one eye done, but Harman said that was not very effective. With another patient, Harman erred in cutting the tiny slits in the sclera and was unable to insert the implants.

Harman, a board certified eye surgeon, took the training twice at seminars and once after that in the last three years.

"You don’t get it all in one sitting," he said.

Thousands of surgeons have been trained in the technique at Presby seminars worldwide, Thaw said.

While the surgery is far simpler than the eye laser surgery Harman regularly performs in Arlington, the theory behind the surgery takes longer to learn.

"You have to believe in the theory before performing the surgery on others," Harman said.

FDA approval is still probably years away, but that may not be long enough to convince doubters such as Wilson.

"The studies in which accommodation were carefully measured before and after surgery suggest that there is minimal effect from this procedure," Wilson said. "I believe it is likely there is a strong placebo effect. Once you’ve spent a couple thousand dollars you really want to read better without glasses.

"I believe it is unlikely this procedure will ever be approved by the FDA in the United States," he said. "I always worry about patients who leave the country to get an unproven procedure."

You can call Herald Writer Marcie Miller at 425-339-3292 or send e-mail to mmiller@heraldnet.com.

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