First femtosecond-only laser vision correction procedure from Carl Zeiss Meditec

Carl Zeiss Meditec has announced that ReLEx, the first femtosecond-only method of laser vision correction, is now available for sale outside the United States.¹ ReLEx is a new application that allows ophthalmic surgeons to perform a variety of complete laser vision correction procedures using only the VisuMax Femtosecond laser.

“After several years of clinical research and development, we are pleased to unveil the first femtosecond-only laser vision correction method as a completely new option in our Refractive Laser Solutions offering, ” said Ludwin Monz, CEO of Carl Zeiss Meditec. “Because the entire procedure can be performed on one advanced system, we are able to deliver unprecedented workflow benefits to the practice. We believe that providing refractive surgeons with a range of flexible treatment approaches allows them to select the most appropriate set of technologies for their surgical settings. ”

ReLEx is Carl Zeiss' brand name for complete laser vision correction procedures that can be performed entirely with the VisuMax Femtosecond laser, such as the Femtosecond Lamellar Extraction (FLEx) method and the Small Incision Lamellar Extraction (SMILE) method. ReLEx uses precise laser cutting, while excimer LASIK uses ablation of tissue. Beyond ReLEx, with the VisuMax surgeons can perform lamellar keratoplasty, penetrating keratoplasty and tissue resection procedures as well as corneal flap cutting procedures.

ReLEx allows for very small flap sizes, typically just 0.5 to 1 mm larger in diameter than the optical zone. Furthermore, ReLEx provides an easier and much faster workflow for the surgeon as the entire procedure can be performed using a single laser. To date, ReLEx procedures have been performed on more than 1000 eyes at a variety of locations outside the US.

In a recent study in which the ReLEx Femtosecond Lamellar Extraction (FLEx) method was performed by Professor Osama Ibrahim, MD at ALEX Laser Center in Alexandria, Egypt, ReLEx compared favorably to LASIK in terms of efficacy, stability, and safety. 102 eyes, (71 female eyes and 31 male eyes) with myopia or myopic astigmatism with a spherical equivalent of -5.07 D +/- 2.77 D were treated. At the 3-month follow-up, 95 percent of eyes treated were within +/-1.00 D and 76 percent of eyes were within +/-0.50 D of intended correction. Mean spherical equivalent was -0.17 D +/- 0.64 D at 1 month. Stability was seen at one week postoperatively. A total of 85 percent of eyes achieved an uncorrected distance visual acuity (UDVA) of 20/20 or greater at 1 month and 84 percent of eyes showed UDVA of 20/25 or better at day one.

No change in corrected distance visual acuity (CDVA) was reported in 69 percent of eyes however, a gain of one or more lines was achieved in 9 percent of eyes. A loss of more than 2 lines occurred in 2 percent at 1 month.

“Until now, laser vision correction has been a two-part process in which the patient must be moved from one platform to another, ” said Professor Osama Ibrahim. “With ReLEx using the VisuMax Femtosecond Laser, I achieved consistently excellent visual outcomes while enhancing patient comfort, both of which are essential to achieve a high level of satisfaction in today's elective surgery environment. ”

Carl Zeiss Meditec continues to perform clinical research for the SMILE method (in which the corneal flap is eliminated). In this procedure, the VisuMax creates a series of small incisions to allow for manual removal of the lamellar without cutting a conventional flap. This next evolution of ReLEx is expected to become commercially available internationally (outside of the United States) in 2011.

1. The VisuMax Femtosecond laser is available for sale in the United States for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. The ReLEx method is not available for sale in the United States.