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Doctors Test New Surgery on Presbyopia

Sabin Russell
  Monday, April 16, 2001

A maverick Texas ophthalmologist has been making waves with a new surgical procedure that he claims can reverse the loss of vision that comes with age.

Known for his unorthodox view of what causes age-related vision loss, or presbyopia, Dr. Ronald Schachar founded a company three years ago that is conducting Food and Drug Administration-sanctioned trials of the experimental procedure.

The surgery involves implant-ing rice-size bits of plastic, called scleral expansion bands, at four points in the whites of the eye, surrounding the iris.

These bands pull back a ring of muscle surrounding the lens and reestablish the tension in the fibers that support it.

Schachar claims a 75 percent success rate has been achieved among the 29 patients who have tried it in the FDA study so far. It's less than perfect, he said, because of variations in surgical skill.

He reports no serious complications so far, and because the operation is not performed on the optical surfaces of the eye, it is reversible. In theory, the beneficial effect of the surgery could last for 20 to 30 years.

Stanford University ophthalmologist Dr. Edward Manche has performed the surgery on five patients in the FDA trial. He said he is not ready to accept Schachar's theories about presbyopia, but was intrigued that numerous patients - including ophthalmologists who had the surgery performed on their own eyes - are pleased with the results. They can read again without glasses.

"He could be completely wrong about the theory, but the operation might still be able to work," Manche said. "So we are putting it to the test." Results so far, he said, have been "mixed," with some patients doing very well,

while others experienced little effect.

While many patients in the study are reporting they can now read without glasses, three patients with improved reading ability that were closely examined by Texas Tech University ophthalmologist Steven Mathews showed no measurable improvement in their ability to focus.

"Some other explanation" than restored focus was needed, to explain their improvement, a skeptical Mathews wrote in the Journal Ophthalmology.

The FDA ordered Presby Corp. last year to stop making health claims on its Web site for a yet-to-be-proven medical device - which prompted Schachar to shift the promotional materials to a link labeled "For Information Outside the U.S.A."

And Schachar has infuriated other eye experts, who are irked by his tendency to compare his critics to Flat-Earthers. "It's nothing new that people can't accept new and controversial ideas," he said.

Houston physiologist Adrian Glasser said that independent investigators have not been able to prove Schachar's theories and that an experiment he performed with Schachar himself failed. "He believed we could do experiments to verify his hypothesis. We did those experiments, and none of the experiments supported it," Glasser said.

Schachar says his critics have simply performed their experiments poorly.

Nonsense, said Glasser. "His theories fly in the face of 150 years of very solid research."


 
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