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Allegretto Wave Eye-Q granted wavefront-guided, mixed astigmatism approvals
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STERLING, Va. — The U.S. Food and Drug Administration has approved wavefront-guided and mixed astigmatism indications for WaveLight's Allegretto Wave Eye-Q system, the company announced in a press release.
The FDA approved the Eye-Q system for reducing or eliminating up to 7 D of spherical equivalent of myopia or myopia with astigmatism, with up to –7 D of spherical component and up to 3 D of astigmatic component at the spectacle plane. The system is approved for use on patients at least 18 years of age who have a documented stable manifest refraction defined as less than or equal to 0.5 D of preoperative spherical equivalent shift over 1 year preop, according to the release.
Procedures performed using the system can also be done with a custom offset of –3 D to +1 D for sphere and –3 D to 0 D for cylinder, the release said.
For mixed astigmatism, the FDA approved the Eye-Q system for reducing or eliminating naturally occurring mixed astigmatism of up to 6 D at the spectacle plane in patients aged at least 21 years who have a documented stable manifest refraction defined as less than or equal to 0.5 D of preoperative spherical equivalent shift over 1 year preop, according to the release.