Abstract
Background: To evaluate the safety, efficacy, and predictability of laser-assisted in situ keratomileusis (LASIK) enhancement after primary LASIK and compare to Food and Drug Administration (FDA) criteria. Methods: Patients who underwent LASIK enhancement after primary LASIK between 2002 and 2019 were compared to those who underwent LASIK without retreatment. Patient demographics, preoperative characteristics, visual outcomes, and postoperative complications were compared between groups. Epithelial ingrowth (EI) development was stratified based on duration between primary and secondary procedures. Results: We compared 901 eyes with LASIK enhancement to 1127 eyes without retreatment. Age, sex, surgical eye, sphere, cylinder, and spherical equivalent (SE) were significantly different between groups (p < 0.05). At 12 months post-enhancement, 86% of the eyes had an uncorrected distance visual acuity of 20/20 or better and 93% of eyes were within ±0.50 D of the target. Development of EI (6.1%) demonstrated an odds ratio of 16.3 in the long-term compared to the short-term (95% CI: 5.9 to 45.18; p < 0.0001). Conclusions: Older age at primary LASIK, female sex, right eye, and larger sphere, cylinder and SE were risk factors for enhancement. Risk of EI significantly increased when duration between primary and enhancement procedures exceeded five years. LASIK enhancements produce favorable outcomes and meet FDA benchmarks for safety, efficacy, and predictability.