KLEx Versus FS-LASIK for the Treatment of Myopia and Compound Myopic Astigmatism

Keratorefractive lenticule extraction (KLEx) is a refractive surgery technique that does not require the creation of a flap to correct the defects. The potential advantages of this technique are related to the absence of a flap, which could make it the gold standard of refractive surgery. On the other hand, femtosecond-assisted laser in-situ keratomileusis (FS-LASIK) is the most widely practiced refractive surgery worldwide, as it offers excellent visual outcomes but does require the creation of a flap to correct the defects. The objective of this study is to evaluate the effectiveness and safety of KLEx versus FS-LASIK as a treatment option in patients with myopia or compound myopic astigmatism. This is a prospective randomized study. A total of 80 participants will be randomized into two groups, the KLEx group and FS-LASIK group. Following randomization, participants will be followed on the first day after the surgery, 1 week, 1, 3, 6, and 12 months. The primary outcome is the refractive predictability at every postoperative point after surgery, which is the proportion of the number of eyes achieving a postoperative spherical equivalent within ± 0.5 diopters of the intended target. Secondary outcome parameters include quality vision measurements, refraction, visual acuity, and adverse events.