In addition to predictable results and excellent visual outcomes, surgeons reported that the ReLEx SMILE procedure on the ZEISS VisuMax femtosecond laser exhibited fast visual recovery with minimal discomfort for their patients.
In the SMILE procedure, surgeons correct patients’ 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. The outer corneal layer remains largely intact, contributing to the eye’s stability – both biomechanical and refractive – and to fast visual recovery.
The FDA approval was welcomed by the US study investigators, who have performed the procedure over the last few years, as well as the community of refractive surgeons who excitedly look forward to offering SMILE to their patients.
Dr. Jon D. Dishler, refractive surgery specialist of Dishler Laser Institute in Denver, Colorado, and US Medical Monitor for the VisuMax IDE Study, said: “We are thrilled that this exciting new technology is available for surgeons and patients in the US. I was very impressed with the excellent refractive outcomes in our clinical study, especially in those patients who were most dependent on their spectacles for daily life. SMILE will become an important addition to our offerings for patients, and a new and appealing option for those who have concerns about existing choices for surgical vision correction.”
“I thank the surgeons and clinics who have paved the way for ZEISS to be able to bring this new innovative technology to refractive practices throughout the US,” says Jim Mazzo, Global President of Ophthalmic Devices, and President and CEO of the company’s US organization. “For the last 5 years, the popularity of SMILE with surgeons and patients outside of the US has continued to grow. With the FDA approval of the VisuMax SMILE procedure, US surgeons now have a new premium laser eye surgery option for their practice and can offer the benefits of SMILE to their patients. The VisuMax SMILE procedure from ZEISS – a major evolution in refractive surgery – has the potential to revitalize and grow the entire US refractive surgery market,” continues Mazzo.
“ZEISS is honored to work with such an esteemed team of clinical investigators to bring this exciting new technology to the US,” says Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec. “Launching SMILE in the US marks the beginning of a new era in ophthalmology for ZEISS and underscores ZEISS’ commitment to bring innovations to market in support of doctors in advancing their patient care and growing their practice.”
ZEISS is also conducting an IDE trial in the US on astigmatic myopia to further broaden the spectrum of SMILE for more patients.
ZEISS VisuMax SMILE will be on display for demonstration at the ZEISS booth at the American Academy of Ophthalmology (AAO) Annual Meeting October 15 – 18, 2016 in Chicago.
Indication 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.