The yellowed newspaper clippings on Nick Siviglia's desk at Lancaster Contact Lens about his lens patents are 20 years old.
The photocopy of a story in the Lancaster New Era — "When LASIK fails" — is from February.
The recent wire-service story tells about a woman from Tennessee who became so depressed when she developed visual distortions after LASIK eye surgery that she tried to kill herself.
Her mental state didn't improve until she was fitted with special contact lenses by a Florida optometrist, "one of a handful of specialists who have had considerable success fitting the lenses," the story said.
Those special lenses, Siviglia said, are the ones described in the yellowed clippings about his 1988 patent — No. 4,787,732.
Siviglia is not concerned about infringement. All 18 of his patents for special lenses have now expired, and other optical designers have developed similar lenses.
He applauds the fact that more people are learning about the benefits of his breakthrough 732 lens.
When LASIK fails and patients don't see as well as before, they do often become depressed, he said. He's seen it in his own practice.
"I just want people … to know there is hope out there to rehabilitate their vision," he said. "And that it all started here."
Siviglia long ago sold an exclusive license to the 732 patent, along with his mathematical formulas for fitting the lens, to Paragon Vision Sciences, an Arizona-based manufacturer of contact lenses.
Paragon, in turn, obtained approval from the U.S. Food and Drug Administration for overnight use of the gas permeable hard lens to reshape the cornea to improve patients' vision, including those who have had LASIK surgery.
The Contact Lens Manufacturers Association gave Siviglia its Creative Design and Process Award for innovation in lens design in 2004 in recognition of the 732 lens.
Lancaster Contact Lens still makes the lenses in its own lab, not only for its patients but also for other eye clinics, including some in foreign countries, Siviglia said.
Siviglia, who lives in Manheim Township, first became involved in making contact lenses at age 14 at Morrison Laboratories in Harrisburg. He went on to earn doctorates in allied health and optical science from Pacific Western and Somerset universities.
In addition to founding Lancaster Contact Lens, which offers a full array of optometrical services, he served as director of the contact lens departments at Penn State Milton S. Hershey Medical Center, 1974-79, and Osteopathic College of Medicine in Philadelphia, 1978-80.
Siviglia's patents grew out of the custom work he does to make and fit contact lenses for patients with a variety of eye diseases and defects. Some of those lenses end up being one-of-a-kind designs.
Lens 732, for instance, was developed before LASIK eye surgery was available and grew out of a custom lens with a flat central surface that Siviglia made in 1977 for a patient whose cornea was devoid of tissue in the center.
The problem was an isolated case, he said, and the lens design sat on the shelf until the 1980s when problems started to surface with misshapen corneas after a surgical procedure called radial keratotomy, which was used to shorten the eye's focal distance to correct myopia, or nearsightedness.
The lens Siviglia came up with to deal with these problems was similar to the 1977 design. The side toward the eye was flat in the center, steepening toward the outside and then flattening again at the outside edge.
The design relied on variable mathematical formulas and was very difficult to manufacture, he said.
A patent search uncovered no lenses of similar design, and Siviglia was first granted a patent for it in 1987.
Realizing that the lens could also be adapted to correct other visual problems, he filed for a new patent with broader applications, which was the 732 patent approved the next year. It was his third patent in three years, Siviglia said, and others soon followed.
The surgical procedure that prompted the 732 patent is no longer used, Siviglia said, and has been replaced by a couple of variations of LASIK (an acronym for laser-assisted in situ keratomileusis).
Siviglia is not in any way a critic of LASIK eye surgery. Many of his patients are referred to him by LASIK surgeons.
In fact, surveys over the past few years by the American Academy of Ophthalmology and the Journal of Cataract Refractive Surgery have found patient satisfaction levels ranging from 92 percent to 98 percent after LASIK eye surgery.
Most of the problems that have surfaced with LASIK have had to do with the flap that is cut and folded back before reshaping the midpart of the cornea, Siviglia said, which has led to refinements in the procedure.
"These days, they use LASIK PRK or thin-flap LASIK," he said.
Of course, LASIK is used to correct many different kinds of eye problems. Patients who have had the surgery to correct nearsightedness, and less commonly farsightedness, are the ones who can benefit from Siviglia's lens 732.
"Patients might do well for six, eight, 10 years," he said. Then, "after a certain amount of time, the patient gets older and starts regressing."
They are then faced with additional procedures to enhance their original surgery or settling for eyeglasses, Siviglia said.
"After they've had LASIK surgery, it's almost impossible for patients to wear normal contact lenses," he said.
That's where Siviglia's formulas for shaping the contact lens comes into play.
By taking measurements of the surface geometry of the corneas and applying his formulas to those measurements, he can produce a contact lens a LASIK patient can wear.
"At the same time," he said, "a lot of the patients who have regressed can be rehabilitated back to normal vision."
The lens can be made so that over time it reshapes the surface of the cornea to a more normal pattern.
Because Lancaster Contact Lens has its own laboratory, Siviglia can have his patients return at intervals so their lenses can be repolished to adjust to the changes in their corneas.
The lens can even be used to correct some patients' nearsightedness without LASIK surgery, Siviglia said.
Dennis Larison is editor of the Business section and can be reached by telephone at 291-8753 or by e-mail at dlarison@lnpnews.com.
