ZEISS ReLEx® SMILE, a new revolutionary minimally-invasive laser eye surgery procedure, which was recently approved by the U.S. FDA*, expands the vision correction options for myopia, or nearsightedness, that U.S. refractive surgeons can now offer their patients. Over 750,000 SMILE procedures have been performed internationally since its introduction in 2011, with over 1000 surgeons regularly performing the procedure. After leading the IDE clinical trial as the Medical Monitor from 2012 to 2016, during which more than 350 eyes were treated, Jon G. Dishler, M.D. at the Dishler Laser Institute was the first to commercially perform the newly approved procedure on a patient in the U.S. on Friday, March 3, 2017. Since March 2017, numerous U.S. surgeons have been trained and are experiencing outstanding success with patients using this new procedure.
ReLEx SMILE, a high-precision procedure, is an innovative minimally-invasive approach to myopia correction that is only available on the VisuMax® femtosecond laser from ZEISS. In the SMILE procedure, surgeons correct patients’ myopia using the VisuMax femtosecond laser to create a precise disc-shaped lenticule within the cornea, which is then removed by the surgeon through a small incision, also created by the laser. SMILE requires only one laser to perform the entire treatment.
“SMILE, the first major advancement in laser vision correction since the 1990s, has been rapidly growing around the world with refractive surgeons seeing excellent refractive outcomes, fast visual recovery, and minimal discomfort for their patients,” says Jim Mazzo, Global President Ophthalmic Devices at Carl Zeiss Meditec. “Now SMILE has achieved two more milestones: the first commercial procedures in the U.S., and over three-quarter of a million procedures performed worldwide.”
“We are pleased that refractive surgeons now have a new laser vision correction option to offer patients, and that this latest advancement in refractive surgery is helping to reinvigorate the market, both in the U.S. and around the world,” continues Mazzo. “ZEISS would like to thank the many doctors, scientists, researchers and other individuals who have worked to bring this innovative, breakthrough laser vision correction technology to patients helping to usher in a new era for refractive surgery.”
ZEISS is also conducting an IDE trial in the U.S. on astigmatic myopia and has submitted an international study outside the U.S. for the treatment of hyperopia to further broaden the spectrum of SMILE for more patients.
* U.S. FDA Approved Indications for Use:
For use in the reduction or elimination of myopia -1.00 D to -8.00D, with ≤ -0.50D cylinder and MRSE -8.25D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year.