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Study: Flapmaker safe, but improvements could be made

Issue: May 1, 2001

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SAN DIEGO—The Flapmaker Disposable Microkeratome by Refractive Technologies offers safety and reliability, yet its safety profile could be improved by changing the rotational cable mechanism.

According to a study presented by Rupal Shah, MD, the overall complication rate was 2.2%. A retrospective study was done on a series of 500 consecutive eyes. Complications included 4 free caps, 1 buttonhole, 2 passes without cutting, and 1 epithelial in-growth. There were no cases of diffuse lamellar keratitis or infection, Dr. Shah said.

"Most of the complications occurred when the rotational cable was worn out due to friction with the lock nut," she said at the ASCRS meeting being held here April 28-May 2, 2001.

Dr. Shah said this is the "only popular" disposable microkeratome. "Our low complication rate could be further improved by changing the rotational cable mechanism."