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Zeiss seeks FDA approval of SMILE procedure for astigmatic myopia
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SAN DIEGO — Carl Zeiss Meditec is moving forward with an FDA phase 2 clinical trial for ReLEx small incision lenticule extraction, a company official said here.
During a media briefing, Dirk Muehlhoff, the company’s head of cataract and refractive surgery, said that Zeiss is seeking approval of a new indication for the ReLEx SMILE procedure, astigmatic myopia.
To date, 39 patients are enrolled for the phase 2 trial at five study sites, Muehlhoff said.
Stephen G. Slade, MD, OSN Refractive Surgery Board Member, is serving as medical monitor for the trial.
The phase 2 trial is designed to evaluate the safety and effectiveness of SMILE in patients with spherical myopia of –1 D to –10 D, astigmatism of –0.75 D to –3 D and manifest refractive spherical equivalent (MRSE) of –11.50 D or less.
Enrollment is complete for a phase 1 clinical trial intended to evaluate the ability of SMILE to reduce spherical myopia, according to the presentation. In that study, 310 of 336 patients have completed 1 year of follow-up, Muehlhoff said. Reduction or elimination of –1 D to –10 D of spherical myopia with MRSE of –10.25 D or less is the goal.
To date, more than 200,000 SMILE procedures have been performed at 300 sites in more than 50 countries, Muehlhoff said.
“The speed of penetration and the speed of adoption are increasing by more than 100,000 procedures just in the last 12 months alone,” he said. “This is now the third generation of laser vision correction, PRK being the first generation, LASIK or femtosecond LASIK being the second generation and now SMILE kind of combining the best of both worlds, a procedure that maintains the biomechanical structure of the cornea.”– by Matt Hasson
Disclosure: Muehlhoff is an employee of Carl Zeiss Meditec.