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Minnesota Eye Consultants Supports Research: FDA Approves First Lens Implant For Patients With Severe Vision Challenges


10/19/2005 5:10:06 PM

MINNEAPOLIS, Sept. 14 /PRNewswire/ -- This week's announcement of approval by the Food and Drug Administration (FDA) of the Verisyse(TM)/ARTISAN(R) phakic intraocular lens ((IOL) serves the most visually challenged individuals -- adults with high degrees of myopia or nearsightedness -- with the potential to restore high-quality vision. Minnesota Eye Consultants, here, has been a primary investigational site for the lens since 1998.

"For patients with severe myopia who are outside of the range for LASIK or PRK -- from a -5 to -20 diopters -- this lens is the most promising option for high-quality vision, with rapid recovery, excellent tolerance and outstanding results," said Dr. David R. Hardten, founding partner and director of research at Minnesota Eye Consultants. "In our clinical trials, with implantation of over 150 of these lenses, patients were extremely pleased with the results."

The lens is implanted by the surgeon, under local anesthetic, using specialized instruments that affix the lens in front of the natural lens of the eye. Following implantation, the lens rests on the outer edges of the iris. Patients who participated in the clinical trials reported little/no discomfort whatsoever from the lens or the procedure, according to Dr. Hardten.

The FDA approval extends to adult patients, ages 21 and older. "Patients with high levels of correction for nearsightedness or thin corneas, who may have not fit the parameters for LASIK or PRK, will be much better candidates for this procedure," said Dr. Hardten. Cost for the procedure will be comparable to LASIK and PRK, according to Dr. Hardten.

Dr. Hardten and his colleagues at Minnesota Eye Consultants, Dr. Richard L. Lindstrom and Dr. Elizabeth A. Davis, authored a textbook on phakic intraocular lenses, which was been widely used by ophthalmologists internationally. They have lectured at the American Academy of Ophthalmology annual meeting and led seminars to train other surgeons on IOL procedures.

"Refractive surgery has experienced considerable and rapid growth in the past decade, with over a million procedures being performed yearly," said Dr. Hardten. "Phakic IOL's will become an excellent addition to respond to patients who need higher levels of correction. We're excited to be at the forefront of this research."

Minnesota Eye Consultants, the ophthalmology practice of Drs. Richard L. Lindstrom, Thomas W. Samuelson, David R. Hardten, Elizabeth A. Davis, William J. Lipham and Patrick J. Reidel, is internationally recognized in research and corneal, cataract and refractive surgery. For further information, visit the website at http://www.mneye.com/ or call 1-800-EYE-TO-EYE.

Minnesota Eye Consultants

CONTACT: Nancy E. Kays of Creative 1, Inc., +1-952-944-1106,nkays@creative1online.com, for Minnesota Eye Consultants


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