FDA approves custom procedures for WaveLight Allegretto laser
The U.S. Food and Drug Administration has approved topography-guided custom ablation LASIK procedures performed with the WaveLight Allegretto Wave Eye-Q excimer laser, Alcon announced in a news release.
The approval is for the Allegretto Wave Eye-Q used in conjunction with the WaveLight Allegro Topolyzer and topography-guided treatment planning software, according to the release.
Surgeons will be able to use customized ablation profiles based on patients’ individual corneal topography. Customized ablation can be performed in addition to wavefront-guided and optimized treatments, the release said.
The proprietary topography-guided LASIK treatment is the first such program to be approved by the FDA, the release said.
In a multicenter phase 3 study using the Allegretto Wave Eye-Q excimer laser for treatment of manifest and cornea-based myopic errors, uncorrected visual acuity of 20/20 or better was attained in 92.7% of eyes. UCVA of 20/16 was achieved in 68.8% of eyes 3 months after surgery. A gain of at least one line of best corrected visual acuity was attained in 29.6% of eyes, the release said.
Alcon will develop educational materials to support the introduction of the technology. Initial clinical use will take place at a small number of experienced sites, with a wider commercial launch in 2014.