Prospective Safety and Effectiveness Study of PRK for Myopia With or Without Astigmatism Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System

This was a prospective, multi-center, single group study. Subjects underwent bilateral PRK in which the second eye was treated no sooner than 1 week and no later than 30 days after the first eye's PRK treatment. Subjects were followed for 2 years after surgery. The protocol underwent 4 amendments. The key differences between the protocol versions were clarifications of the planned analyses and adverse event reporting procedures. There were no changes in the inclusion and exclusion criteria or non-adverse event related study assessments between the protocol versions 1-5. Refractive stability of manifest refraction spherical equivalent (MRSE) and manifest refractive cylinder was defined as established when: At least 95% of the treated eyes had a change ≤ 1.0 diopter between manifest refractions performed at any 2 manifest refractions at least 3 months apart The mean rate of change, as determined by a paired analysis, was ≤ 0.5 diopter per year (0.04 D/month) over the same time period The mean rate of change decreased monotonically over time, with a projected asymptote of zero or a rate of change attributable to normal aging The 95% confidence interval for the mean rate of change included zero or a rate of change attributable to normal aging. Refractive stability was assessed for pairs of visits within an interval and was defined to occur at the latter time point of the first interval at which stability was achieved. In the final amendment to the protocol, 3 secondary objectives were made co-primary in response to Agency comments. All endpoints and analyses were modified to match.