The article provided an update to the U.S. Food and Drug Administration's long-term, follow-up multi-center STAAR Myopic Implantable Contact Lens (ICL) clinical investigation. The STAAR ICL is one of the lenses expected to receive FDA approval. A competing ICL, the Verisyse lens, to be sold by AMO Inc., has received approval by the FDA's device panel and is also expected to receive FDA approval at about the same time.
For the study, the STAAR myopic ICL was implanted in 526 eyes of nearly 294 patients whose myopia ranged from -3.0 to -20.0 diopters. The lens was inserted through a tiny incision and placed in front of the eye's natural lens. The study found that at three years, nearly 60 percent of the patients had 20/20 or better visual acuity and nearly 95 percent had 20/40 or better. Reports of symptoms such as glare halos, double vision, night vision and difficulty driving at night either decreased or remained unchanged. Ninety seven percent of the patients said they would chose ICL implantation again. Less than one percent of the patients said they were dissatisfied.
When compared with the refractive surgical procedure, LASIK, the ICL was found to be more effective for those with higher degrees of myopia. The study states, "These data suggest that the ICL should be given serious consideration for use in eyes with -7 diopters of myopia or more."
"While LASIK is the best surgical option for many patients, there can be more complications for patients with a higher range of myopia. Implantable contact lenses may be a good option for those patients," said Academy Spokesperson Peter Kastl, MD, Ph.D., professor of ophthalmology and adjunct professor of biochemistry at Tulane University in New Orleans.
The study was funded by STAAR Surgical of Monrovia, Calif.
The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons--Eye M.D.s--with more than 27,000 members. For more information about eye health care, visit the Academy's partner Web site, the Medem Network, at http://www.medem.com/eyemd. To find an Eye M.D. in your area, visit the Academy's Web site at http://www.aao.org.
Journal
Ophthalmology