Purpose: To investigate the safety, efficacy, and visual quality of small incision lenticule extraction (SMILE) in different corneal thickness patients with myopia or myopic astigmatism.
Methods: This prospective cohort study included 191 right eyes of 191 patients. Eyes were divided into three groups according to preoperative central corneal thickness (CCT) (Preoperative central corneal thickness (CCT) was the group indicator.) There were 31 eyes in the thin cornea group (CCT ≤500 um (μm), TC), 94 eyes in the moderate corneal thickness group (CCT ≥501 um (μm) and ≤550 um (μm), MD) and 66 eyes in the thick cornea group (CCT ≥550 um (μm), TK). Comparisons in uncorrected (UDVA) and best-corrected distance visual acuity (BDVA), manifest refractive spherical equivalent (SE), preoperative mesopic/photopic contrast sensitivity (CS), ocular higher-order aberrations (HOAs) at a 6mm analytical pupil diameter, and visual quality questionnaires were made (performed) among the three groups during the postoperative six months. Subgroup analyses were made based on preoperative SE.
Results: The safety indices at six months were 1.15 ± 0.18, 1.14 ± 0.17, and 1.18 ± 0.17, respectively (p = 0.374), and the efficacy indices at six months were 1.07 ± 0.25, 1.12 ± 0.22, and 1.11 ± 0.21, respectively (p = 0.599). The postoperative SE was -0.07 ± 0.52D, -0.14 ± 0.38D, and -0.05 ± 0.46D after SMILE in the three groups, respectively (p = 0.376). No significant difference was found in mesopic/photopic CS, HOAs, and visual quality among different corneal thickness groups and SE groups. Postoperative SE and efficacy indices were the lowest in thin cornea eyes with ultra-high myopia (over -9.00 D).
Conclusions: SMILE provides comparable safety, efficacy, and visual quality results in different corneal thickness patients. Those with myopia higher than -9.00 D had less efficacy after surgery, especially in thin cornea patients.
Keywords: Corneal thickness; efficacy; safety; small incision lenticule extraction (SMILE); visual quality.