Wavefront-optimized versus wavefront-guided LASIK for myopic astigmatism with the ALLEGRETTO WAVE: three-month results of a prospective FDA trial.

PURPOSE To compare visual outcomes using the WaveLight ALLEGRETTO WAVE to administer either wavefront-optimized (standard LASIK) or wavefront-guided (custom LASIK) treatments in myopic eyes. METHODS In this prospective, open-label, multicenter study conducted in the United States, 374 eyes were randomized by alternating enrollment to receive either wavefront-optimized or wavefront-guided LASIK treatments with this laser platform. Bilateral treatments were administered, with both eyes of each patient receiving the same treatment. Corneal flaps were created using the IntraLase femtosecond laser. RESULTS In this FDA clinical trial, results at 3 months postoperatively revealed that 93% of eyes in both cohorts receiving either wavefront-optimized or wavefront-guided treatments attained an uncorrected visual acuity (UCVA) of 20/20 or better. Seventy-six percent of eyes with the wavefront-optimized treatment and 64% of eyes with the wavefront-guided treatment achieved UCVA of 20/16 or better. None of the eyes that received either treatment lost two lines or more of best spectacle-corrected visual acuity (BSCVA). In addition, 58% of eyes with wavefront-optimized treatment and 62% of eyes with wavefront-guided treatment gained one line or more of BSCVA. None of the eyes in either treatment group underwent retreatment. CONCLUSIONS In the majority of eyes, no statistically significant differences were found between either treatment group in regard to visual acuity and refractive outcomes. Wavefront-guided treatments are not required in most cases with this laser, but may be considered if the magnitude of preoperative root-mean-square (RMS) higher order aberrations is >0.35 microm. In this study population, 83% of eyes had preoperative RMS higher order aberrations of <0.3 microm.