News » FLEx: The next big thing in laser vision surgery?

A new all-laser eye surgery appears to be safe and effective for the treatment of nearsightedness. Called femtosecond lenticule extraction (FLEx), the investigational procedure uses a different type of laser than the excimer laser used for LASIK. The procedure is performed using a femtosecond laser - the type of laser used to create the corneal flap in all-laser LASIK. But in FLEx, the femtosecond laser has two roles: It creates a corneal flap and also cuts a small lens-like segment of tissue (the lenticule) within the cornea. Once the flap and lenticule are created, the surgeon lifts the flap, manually removes the lenticule, and replaces the flap. With the lenticule removed, the shape of the cornea is changed, which corrects nearsightedness.

Marcus Blum, MD, a refractive surgeon in Germany, recently conducted a study of FLEx and reported the results at the 2007 annual meeting of the American Academy of Ophthalmology. A total of 45 nearsighted eyes (with or without astigmatism) were treated. The average amount of myopia in the eyes prior to surgery was -4.50 diopters (D). The range was -2.75 D to -7.25 D.

Results of the surgery were measured over a 6-month period. Measurements included: uncorrected visual acuity (UCVA) after FLEx, wavefront evaluation of higher-order aberrations (HOAs) and a comparison of best spectacle-corrected visual acuity (BSCVA) prior to and after the surgery.

Adverse events and complications following FLEx in this study were limited to a single eye exhibiting mild corneal haze and a few eyes having microstriae (microscopic folds within the corneal flap). In addition to appearing to be safe and effective, FLEx may offer certain advantages over LASIK and other laser vision correction procedures that use an excimer laser. The results of Dr. Blum's study suggest that FLEx may induce fewer higher-order aberrations (HOA) than LASIK, thereby decreasing the risk of halos and glare after the procedure.

At this time, FLEx is currently not approved by the U.S. Food and Drug Administration (FDA) for use in the United States.

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