Abstract
Purpose: To explore the long-term (13-year) outcomes associated with keratorefractive lenticule extraction (KLEx) among patients with myopia up to -10 dioptres. Methods: This prospective, nonconsecutive case series included 29 patients (29 eyes) who underwent KLEx procedures from May, 2010, through March, 2013, at the Fudan University Eye and ENT Hospital. Analyses performed preoperatively and at the 1-month, 1-year, 5-year, 10-year, and 13-year postoperative time points included measures of uncorrected and corrected distance visual acuity (UDVA and CDVA), objective and manifest refractions, intraocular pressure, axis length, slit-lamp examination, and corneal tomography. Results: All surgeries were performed without any complications. A UDVA of at least 20/25 was achieved in 29 eyes (100%), while 10 eyes (43.4%) exhibited unchanged CDVA, and no lines were lost for any eyes. Additionally, 21 eyes (72%) and 28 eyes (97%) were, respectively, within ±0.5 D and ±1.00 D of the target refraction. The mean refractive regression from 1 month to 13 years after surgery was -0.26 ± 0.41 D. No significant changes in posterior central elevation (PCE) or △PCE were noted at the follow-up time points (all p > 0.05). Significant postoperative increases in higher-order aberrations and vertical coma were observed postoperatively (p < 0.001), and these remained largely stable over the follow-up period (all p > 0.05). Conclusion: These 13-year follow-up results highlight the safety, stability, and predictability of KLEx as an approach to treating myopia up to -10 dioptres.