A new all-laser eye surgery appears to be safe and effective for the treatment of nearsightedness. Called femtosecond lenticule extraction (FLE or 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 FLE, 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 FLE 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 FLE, wavefront evaluation of higher-order aberrations (HOAs) and a comparison of best spectacle-corrected visual acuity (BSCVA) prior to and after the surgery.

Of 45 eyes undergoing the FLE procedure, at 6 months after surgery:

• About two-thirds of the eyes had UCVA of 20/20 or better.
• 40% of the eyes had gained one line of BSCVA.
• 7% of the eyes lost one line of BSCVA.
• 90% of the eyes had less than 1 D of residual refractive error.

Adverse events and complications following FLE 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, FLE 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 FLE may induce fewer higher-order aberrations (HOA) than LASIK, thereby decreasing the risk of halos and glare after the procedure.

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


SOURCE: "All-femtosecond laser myopic surgery appears promising in early outcomes." Ophthalmology Times. January 1, 2008.


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