Implantable Contact Lens Coming Your Way
Until now, the only lenses implanted in American eyes were when patients developed cataracts, which is a disease that obscures vision by clouding the natural lens. Meanwhile, surgeons are flocking to learn a new technique from the lead investigator, Kerry Assil, M.D. in Santa Monica, California.
"So far, I've trained about 300 surgeons to use the F.D.A. approved Verisyse procedure in which a tiny plastic lens is implanted behind the cornea of the eye," Dr. Assil told iEnhance.com. "Another 300 surgeons are scheduled for the remainder of 2005, so the procedure should be more widely available soon."
The most appropriate patient for the new eye surgery is the person who is too nearsighted to benefit from the ever-popular Lasik surgery, which corrects vision by shaving tiny amounts of tissue from the eye. For the extremely nearsighted, the Lasik shaves too much tissue from the cornea.
Dr. Assil -- who is additionally seen as the eye surgeon on the '04-'05 season of TV's "The Swan," -- says the Verisyse procedure requires about 10 to 15 minutes to perform, does not remove any tissue from, nor reshape, the eye and does not remove the existing, natural lens within the eyeball. Unlike Lasik, the implant surgery must be done in a sterile operating room.
Competition has been stiff among a handful of U.S. and foreign companies who have been developing similar products and hungering to rush them to market. The technology is known to doctors as Phakic intraocular lens, or IOLs for short. ("Phakic" means the natural lens is left inside the eye when a corrective lens is implanted.) Many eye surgeons see the IOL as a treatment for farsightedness, nearsightedness, and astigmatism, the vision disorder in which both conditions are present. About 100,000 eyes in Europe have received an intraocular lens, reportedly with good results.
According to experts, the possible risks of implanting a corrective lens within the eye include bleeding, infections, the implant shifting, and changing prescriptions, which would mandate insertion of a new lens.
"The only lenses that have shifted so far were in patients who were hit in the eye," Dr. Assil says. "Moreover, infections are possible but we never had one in our test group of 1,000 eyes and, as far as I know, there has never been an infection case in any of Europe's Verisyse implants."
The procedure and lens, developed by Ophtec BV, an optics company in Holland, has been used for about ten years throughout Europe and is extremely popular with soccer players who often "head," or bat, soccer balls with the tops of their skulls. According to Dr. Assil, infections are unlikely because the lens "sits in a river" where it is constantly washed with tears. A little less than one percent of test patients chose to return to wearing contacts or glasses. The actual lens in the Verisyse procedure is made from the same plastic polymer used for the last fifty years in cataract lens operations. The operation requires only a local anesthesia.
In the U.S., a handful of celebrities – Brad Pitt, Courtney Cox, Blair Underwood, Carol King, and John Salley – have opted for the Verisyse implant and later wrote glowing testimonials for Dr. Assil's website.
In additional to his other credits, Dr. Assil is director of education for Advanced Medical Optics, the U.S. distributor. Just after the lens was approved last September, the surgeon implanted a lens on live television and, according to Good Morning America, saved the vision of a woman who was legally blind. In April, 2005, Time magazine named the implantable contact lens one of the "coolest inventions of 2004."
"In our study group, about seven percent of patients needed to adjust their vision prescription over seven years," Dr. Assil says. "We found that a quick touch-up with Lasik restored clear vision."
An unexpected finding in the study was that most prescriptions stayed the same during the test period. Dr. Assil and colleagues think the study subjects required such high correction, their brains were constantly trying to change the shape of the eye through feedback to produce better vision. Scientists have long observed a sympathy effect in and around the eyes. For instance, if one eye develops a droopy eyelid, the other is likely to follow suit. In worse case scenarios, one eye goes blind and, in many cases, the other follows.
"There are many models that try to explain the effect but we did document that the study subjects' prescriptions stayed pretty solid," says Dr. Assil. Moreover, if a patient's prescription does change, he or she may do well with just a pair of reading glasses.
Current total costs for implanting the lens in both eyes range from $4,000 to $5,000, says Dr. Assil, who estimates that there are about eight to ten million people who could benefit from the surgery, with about five percent of Lasik patients also being appropriate candidates for the procedure.