Interim (three-month) LASIK results with the WaveLight Allegretto Wave Excimer Laser System

摘要

Purpose: The interim (three-month) results of a US Food and Drug Administration (FDA) Inves-tigational Device Exemption (IDE) trial of the WaveLight Allegretto Wave Excimer Laser System for the LASIK treatments of spherical and spherocylindrical myopia are presented. Methods: The study is being conducted at 11 sites in the USA, using a protocol that follows the published FDA guidance for excimer laser studies. The results are evaluated against prospectively defined targets for safety and effectiveness. Results: The outcomes of 751/808 (93%) eyes of 418 subjects enrolled at 11 sites from February through September 15th, 2001, are included in this report. There are 241/751 (48%) sphere and 510/751 (52%) spherocylinder treatments, ranging up to -12 D sphere and -6 D cylinder. An uncorrected visual acuity (UCVA) of 20/16 or better was achieved in 59.3% eyes targeted for distance vision. UCVA 20/20 or better was achieved in 86.2% of eyes (target 50%). The + 0.50 D rate was 649/750 (86.5%) for all eyes (target 50%). On average, eyes gained 0.70 lines (standard deviation (SD), 0.87 lines) of best spectacle-corrected visual acuity (BSCVA), with a loss of two or more lines occurring in 3/750 (0.4%) eyes (target < 5%). Discussion: Each of the protocol targets was easily exceeded, and the results compared favorably with similar regulatory studies submitted for other lasers. Further follow-up is needed to evaluate refractive stability, patient subjective results, and other protocol targets.