The FDA approved Carl Zeiss Meditec’s laser for the treatment of myopia, or nearsightedness, in patients aged 22 and older.
The VisuMax Femtosecond Laser corrects myopia by removing eye tissue to permanently reshape the cornea. A femtosecond laser delivers very quick, short pulses of light to make incisions in the cornea, resulting in a disc-shaped piece that is removed through a small cut in the corneal surface, the FDA said in a statement. The minimally invasive procedure is known as small incision lenticule extraction (SMILE).
“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 … has the potential to revitalize and grow the entire US refractive surgery market,” said Jim Mazzo, global president of ophthalmic devices, and president and CEO of the Zeiss’ U.S. organization, in a statement.
All but one patient in a 328-patient clinical study had uncorrected visual acuity of 20/40 or better 6 months after the procedure, according to the FDA statement. And 88% had 20/20 vision or better at the 6-month mark.
Some common complications that followed surgery include dry eye, moderate to severe glare and moderate to severe halos, the FDA said. These are complications that can come after Laser-Assisted In Situ Keratomileusis, or LASIK, another surgery to change the cornea’s shape, which has been in use since 1998. Zeiss manufactures two lasers that are FDA-approved for LASIK.
Unlike LASIK, which requires a flap to be cut into the cornea and folded back, SMILE is a flapless procedure, Zeiss said in the statement. This means that the outer layer of the cornea stays mostly intact, which leads to fast visual recovery.