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FDA Approves Same Day 2nd Eye Laser Treatment

Photonics.com
Jul 1999
FREMONT, Calif., July 21 -- Sunrise Technologies International, Inc. reports that it has received conditional approval from the US Food and Drug Administration to treat both patients' eyes on the same day as part of its ongoing US clinical trials of the company's laser thermal keratoplasty (LTK) treatment. LTK is used to treat mid-hyperopia, or farsightedness, from +2.75 to +4.0 diopters; the company estimates that nearly 90 percent of all hyperopes over age 40 fall under the four diopters limit.
FDA approval allows for treatment of the second eye of the current subjects as well as treatment of both eyes of future subjects on the same day. On May 4, 1999, Sunrise announced that it had received approval from the FDA to expand its study to 80 patients at up to six clinical sites in the US.


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