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STAAR Surgical's three-year study with its implantable lens found that nearly 60 percent of the 294 subjects wound up with 20/20 or better vision, and 95 percent achieved 20/40 or better. Almost all of the patients said they would have the surgery again, and fewer than 1 percent said they weren't happy with the results. The study is published in the September issue of Opthalmology. The surgery takes about eight minutes and is performed using only anesthetic eye drops. The patient can see clearly immediately following the surgery.
FDA approval is imminent for a permanent, implantable lens that can help even the most nearsighted patients. The images show a surgeon implanting the lens through a 3 millimeter incision under a topical, eye-drop anesthesia.
The Verisyse lens corrects moderate to high nearsightedness. A surgeon positions it over the pupil between the iris and the cornea. It will remain in its proper location permanently but can be surgically removed if desired.
"For someone who describes their glasses as coke bottles to be able to see without glasses, and pass a driver's test, it's not an overstatement to say it's a life-altering experience for many of these patients," said John Vukich, surgical director at the Davis Duehr Dean Center for Refractive Surgery in Madison, Wisconsin. Vukich is a consultant for STAAR Surgical, and medical monitor for the company's US The study took place at 15 sites throughout the United States. The technique is a breakthrough because it's the first time that people with severe myopia have a choice other than thick glasses or contact lenses.
LASIK, which has become increasingly popular in the past decade, doesn't work for severely nearsighted patients. "(The lens implant) has applications in individuals who are laser candidates as well, but the ability to correct into high ranges of nearsightedness is where the real breakthrough is," Vukich said. The lens is made of a soft material called collamer, which is a blend of collagen and polyhema, a common lens material. It has "shape memory," Vukich said, so it can be folded into a tiny roll and unfolded after it's inserted in the eye." Because the lens can be rolled up, the surgeon makes just a 3 millimeter incision in the eye that requires no stitches. Potential complications include the possibility that the new lens could rub the natural lens, causing cataracts or other irritations. In the study, surgeons removed lenses from three eyes that had developed cataracts. The lens was designed to remain in the eye permanently, but if a patients vision changes, the lens can either be removed and changed, or the patient can get regular corrective glasses, contact lenses or LASIK surgery. Another implantable lens is running neck and neck with STAAR for FDA approval.
Advanced Medical Optics, was developed by a Dutch physician in the late 1970s and has been successfully implanted in about 100,000 patients in other countries. Verisyse requires a larger incision than the STAAR lens because it's hard and does not roll up, and therefore requires stronger anesthetic. The procedure for the Varisyse lens takes about 15 minutes. Advanced Medical Optics also expects FDA approval any day. The procedure is expected to cost twice as much as LASIK surgery, which runs about $1,000 per eye. End of story Send e-mail icon Have a comment on this article?
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