Blind World


Implantable Ocular Lenses.
Implantable lens is a new vision correction option.





November 2, 2004.

BY DEBBE GEIGER
Newsday.




Karen Lutz of Lake Grove had been wearing contact lenses for more than 22 years, and it was starting to take a toll on her eyes.


About a year ago, the contacts had irritated her eyelids so much that Lutz was forced to switch to glasses. But her strong prescription made the glasses weigh heavily on her nose. The 34-year-old accountant looked into LASIK, the current standard in laser vision correction surgery, but learned she wasn't a candidate because her corneas were too thin. Then she read about an intraocular lens implant called the Artisan lens that had been used for 18 years in Europe.


A few overseas phone calls led her back to Long Island and the offices of Dr. Eric Donnenfeld, an ophthalmologic surgeon at Ophthalmic Consultants of Long Island in Rockville Centre who was about to start an investigational clinical trial with the lens. In April, a tiny lens was implanted under the natural lens in her right eye. By the following day, her vision was nearly perfect.


"The next day my husband drove me to the doctor, and I was so excited because I was able to see all the license plates," Lutz recalled. "I could read all the signs. For the first time I could see everything crystal clear. After wearing glasses for so long, to wake up in the morning and see my husband, and see the alarm clock, is the most amazing feeling." Last month, Lutz had the implant put in her left eye.


Approved by the Food and Drug Administration in September to correct moderate to extreme nearsightedness, the Verisyse lens - which will be marketed in the United States by Advanced Medical Optics of Santa Ana, Calif. - is the first in the United States of a new class of implantable ocular lenses that represent a significant advance in vision correction surgery. Similar lenses are in clinical trials, with another one expected to be approved shortly.


"You can take someone who is legally blind [without glasses], give them these intraocular lenses, and get some of them to the point where they can drive without glasses," said John Ciccone, director of communications for the American Society of Cataract and Refractive Surgery.


Brian Martin of Manchester, Conn., was one of those patients. At 45, Martin had been wearing contact lenses for most of his life. "Without them," he said, "I couldn't tell you how many fingers I was holding up."


He underwent the first implant procedure six months ago as part of the clinical trial and had his other eye done last month. "It's nothing short of miraculous," he says. "I had good vision with contacts, but this is even better."


LASIK alternatives


For most people seeking vision correction, LASIK, which uses a laser to sculpt a prescription onto the exposed surface of the cornea, is still the answer. But the Verisyse lens and several other alternatives that have recently become available are making vision correction possible for the 3 million people who are not candidates for LASIK because of extreme nearsightedness or farsightedness, thin corneas and other medical conditions, said Dr. Gregory Pamel, who has been performing the implant surgery for the past four years as a principal investigator in the FDA trials.


The Verisyse lens works like a tiny contact lens inside the eye, explained Dr. Robert Maloney, an associate clinical professor of ophthalmology at the University of California at Los Angeles. It clips on to the front of the iris, the colored part of the eye.


"It gives you permanently corrected vision," he said.


Also a principal investigator in the clinical trials, Maloney says the new lens holds several advantages over LASIK. "With the implantable lens, we find people are less likely to get glare at night, they don't experience hazy vision or ghost images, which can happen when one does LASIK for extreme nearsightedness," he said.


Unlike LASIK, which can be refined but not reversed, this lens is removable. "If someone isn't satisfied with the quality of their vision after the lens is implanted, it can be taken out and exchanged for a more accurate lens," Maloney said.


Risks and drawbacks


On the flip side, implanting the lens is more invasive than LASIK. The procedure must be performed in an ambulatory surgery center. It takes longer to perform - up to 30 minutes - and only one eye can be done at a time, to see how the patient responds. By comparison, LASIK is done in a doctor's office, takes about five minutes per eye, and both eyes can be treated in one visit.


The implantable lens also carries some risks.


"As with any surgery to the eye, there is risk of infection, cataract and damage to the cornea, which potentially could be blinding or require major surgery to correct," said Maloney. The FDA clinical trials did not report any significant complications.


It's possible for patients to experience "some glare around lights at night," added Maloney, but less so than with LASIK. One percent of patients in the clinical trial were unable to tolerate the lens, and it had to be removed. There is also some concern over the loss of endothelial cells, which are essential to keeping the cornea clear, said Ciccone. Long-term studies will continue to track any potential problems. Studies in Europe did not find this problem. Studies are also under way to test the lens for use in correcting farsightedness.


According to Glenn Hagele, executive director of the Council for Refractive Surgery Quality Assurance, a nonprofit consumer advocacy organization in Sacramento, the No. 1 issue is the skill of your surgeon.


"This is not a procedure that a mediocre surgeon will do well. It's going to be very important that the patient look at the practical knowledge of their potential surgeon. The surgeon may not have implanted this specific lens. It may be that a cataract surgeon will have more skill with this particular surgery than a LASIK doctor," Hagele said.


Hagele testified at the FDA hearing about the concerns his group had when the lens was approved. He says that at some point the lens may have to be removed and additional surgery performed either because the patient develops cataracts or glaucoma as part of the normal aging process, or because of some disruption caused by the lens. "The concern is that the patients won't do the annual follow-up. This is not something they get done once and go on their way. It needs to be evaluated on a regular basis, because at some point it may need to come out."


In the meantime, other new options are available.


Conductive keratoplasty (CK), which has been around for about two years to treat farsightedness, was approved in March for the treatment of presbyopia, a condition associated with aging in which the eye's lens loses its ability to refocus quickly at different distances. In CK, a needle gives off heat in the form of radio waves to reshape the cornea. That changes the way light rays enter the eye and results in clearer vision up close, said Donnenfeld, who also maintains a practice at TLC Laser Center in Garden City.


Some doctors use CK to create a "reading eye" for patients while leaving the other eye for distance. Pamel, an attending surgeon at Manhattan Eye, Ear and Throat Hospital, says this technique, called monovision, can also be achieved with LASIK. "CK is less invasive. You're not cutting the cornea, you're inserting a probe." But, he adds, it's also short-term. "Over time the effect that CK has on the cornea tends to wear off." The procedure then can be repeated.


Monovision isn't for everybody. When one eye is corrected for vision, and the other for distance, the two eyes no longer work together. The FDA reports that many patients have trouble getting used to having one eye blurred all the time. It also says that poor quality vision and a decrease in depth perception can result, and that it is most noticeable in low lighting conditions and when performing tasks that require sharp vision. Some people find they need to wear glasses or contact lenses to fully correct both eyes when driving at night or reading small print.


Another choice


Another new technology, which has advanced the use of LASIK, is called "wavefront-guided ablation," or custom LASIK. Computer software maps out small irregularities in the cornea that normally could not be treated and then guides the laser to perform the correction surgery. "These mild irregularities are so subtle they couldn't be treated before," Donnenfeld said. "With these new lasers, we can now measure them with wavefront analysis. It improves the quality of vision in most patients. It gives us the ability to treat patients to a level of accuracy that was incomprehensible before."


Linda Ricciuoto of Syosset wore glasses for the past 10 years. The 32-year-old student says wavefront was recommended because she had large pupils. She underwent the procedure in May 2003 and says it has made a big difference.


"It's wonderful. My vision is sharper than it was with my glasses. I see colors more vividly. It's unbelievable to see the blackboard from the back of a lecture hall and not have my glasses on."



Debbe Geiger is a freelance writer.



Copyright Newsday, Inc.




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