First SMILE Vision Correction Procedure for Myopia Performed in the US

Source: Carl Zeiss Meditec

Monday, March 06, 2017 | FDA Approval/Clearance , Carl Zeiss Meditec


Following the recent FDA approval for the ReLEx SMILE (small-incision lenticule extraction) procedure, Jon G. Dishler, MD, at the Dishler Laser Institute, became the first to perform this procedure on a patient in the United States on March 3, 2017.

ReLEx SMILE is a minimally-invasive corneal refractive procedure which can only be performed with the VisuMax femtosecond laser from Zeiss. With this new treatment option recently receiving FDA approval, ReLEx SMILE is now available in every major market globally.

“We are excited to see the first SMILE procedures in the US. SMILE, the first major advancement in laser vision correction since the 1990s, promises to reinvigorate the refractive market by providing surgeons a new premium laser vision correction option for their practice,” Jim Mazzo, Global President Ophthalmic Devices for Carl Zeiss Meditec, said in a company news release. “SMILE has been growing in popularity with surgeons and patients around the world for the past five years. Over 1000 surgeons are now regularly performing SMILE procedures in their clinics, and now refractive surgeons across the U.S. can bring the benefits of SMILE to their patients.”

In the SMILE procedure, surgeons correct patients’ myopic refractive errors using the Zeiss VisuMax femtosecond laser to create a thin disc-shaped lenticule within the cornea, which is then removed by the surgeon through a small incision on the surface of the cornea, also created by the laser. SMILE is a flapless procedure, which requires only one laser to perform the entire treatment. In the US, the ReLEx SMILE procedure is indication for 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.

“Today, a new era in refractive surgery begins in the US. Thanks to the excellent work of the many individuals in our clinical study, US doctors can now offer their patients this innovative, breakthrough minimally-invasive laser vision correction procedure,” Dr. Dishler, refractive surgery specialist, founder of the Dishler Laser Institute and US Medical Monitor for the VisuMax SMILE IDE Study, said in the news release. “I am honored to have been given the opportunity to perform the first ReLEx SMILE procedure in the US. With SMILE, US surgeons now have a new proven way to help patients who have concerns with conventional vision correction methods – such as eyeglasses, contact lenses or existing LVC procedures – to improve their vision and their quality of life. I was very impressed with the excellent refractive outcomes in our clinical study, especially in those patients most dependent on spectacles or contacts in their daily life. Surgeons will also find SMILE appealing to patients as it is a quick, minimally-invasive procedure with fast visual recovery and minimal discomfort.”

“This first SMILE procedure performed in the U.S. by Dr. Dishler represents years of collaboration between leading doctors and scientists around the world. Zeiss is pleased to play an integral role in bringing this latest innovation to doctors to help them to advance eye care and improve quality of life for their patients,” says Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec.

ZEISS is also conducting an IDE trial in the US on astigmatic myopia to further broaden the spectrum of SMILE for more patients.

 


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