November 19, 2004

Study ‘eyes’ alternative to LASIK

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Study ‘eyes’ alternative to LASIK

A new investigational procedure could provide clearer vision for those who couldn't see LASIK surgery in their future. Instead of altering the cornea with a laser beam, the new procedure is intended to correct vision with a surgically inserted lens.

“For many patients with severe near sightedness, their only option is to wear glasses or contacts, because their corneas are too thin for LASIK surgery,” said Jeffrey Horn, M.D., assistant professor for the Vanderbilt Eye Institute and surgeon for the new clinical study. “We hope this procedure will give these patients another possibility.”

Patients enrolled in the clinical study of the Acrysof phakic intraocular lens will have a small lens surgically inserted into one eye. Because the investigational lens is pliable, the surgery requires a very small incision similar to the size used in today's cataract surgeries and most likely will not need stitches. In about the same time it takes to perform LASIK or cataract surgery, the investigational lens can be placed in the eye in front of the iris.

“The investigational lens is made from a soft, gentle acrylic material. This same Acrysof material is also used in lenses that treat cataracts and was implanted in approximately 175,000 patients nationwide who underwent cataract surgery last year. Close to 20 million of these cataract lenses have been implanted globally since it was first developed for medical use,” Horn said.

“Because we are not altering the corneal curvature, as is done with laser vision correction, but rather inserting a new investigational lens into the eye, the quality of vision should be preserved and in some patients in the study, it has even improved,” Horn said.

Recently the Food and Drug Administration approved the use of a similar type of lens and will review the performance of this investigational lens at the conclusion of this clinical study.

The recently approved lens requires a 6 mm incision, stitches, and the eye must be anesthetized with an injection for the procedure. The Acrysof lens requires a relatively small incision and can be inserted under local anesthesia in the form of eye drops.

“I am very proud and excited to be in this study,” Horn said. “More so, I feel being chosen to participate in this clinical study is further evidence that the Vanderbilt Eye Institute is one of the nation's premier eye and refractive surgery centers.”

Healthy patients, age 18 to 49, with stable, severe near-sightedness, and who can tolerate their contact lenses are being recruited for this clinical study. Participants will receive the consultation, lens and follow-up visits free-of-charge, but will be responsible for certain operative fees. The study will last about three years.

For more information, contact Sandy Owings or Genise Mofield at (615) 936-3465 or e-mail: sandy.owings@vanderbilt.edu or genise.g.mofield@vanderbilt.edu.