Abstract

Purpose To investigate the long-term outcomes of refraction, corneal tomography, and wavefront aberrations after small incision lenticule extraction (SMILE) for moderate and high myopia. Methods Prospective, nonconsecutive case series. A total of 26 patients (26 eyes) who underwent SMILE from May 2010 to March 2013 at the Fudan University Eye and ENT Hospital (Shanghai, China) were enrolled. The periods of follow-up were 1 month, 1 year, 5 years, and 7 years after surgery. The routine eye examinations included uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), manifest refraction, and corneal tomography. Results All surgeries were executed without any complications. At the final visit, an UDVA of 20/20 or better was achieved in 26 eyes (100%) and 11 eyes (42%) exhibited no change in CDVA. 9 eyes (35%) gained one line, 6 eyes (23%) gained two lines, and no eyes lost CDVA. 24 eyes (92%) and 26 eyes (100%) were within ±0.5 D and ±1.00 D of the target refraction, respectively. A mean refractive regression of −0.17 D was observed between 1 month and 7 years postoperatively. Mean corneal front curvature (MCFC) was significantly decreased between pre- and post-SMILE surgery (P < 0.0001). Higher-order aberrations (HOAs) and vertical coma were significantly increased after SMILE compared to those measured before surgery (all P < 0.001). There were no significant differences in trefoil and spherical aberration between pre- and post-SMILE surgery (all P > 0.05). Conclusion SMILE is an effective, safe, and stable procedure for moderate and high myopia, with relatively constant corneal stability and wavefront aberrations. This trial is registered with ChiCTR-ONRC-13003114.

Highlights

  • As opposed to flap-based surgical procedures, small incision lenticule extraction (SMILE) is a minimally invasive refractive surgical technique that involves the manual removal of femtosecond laser-created intrastromal lenticule through a small side cut

  • Numerous clinical studies [3,4,5,6,7,8,9] suggested that SMILE is a safe and effective procedure for myopia correction, and the follow-up periods in these studies mostly spanned from 3 months to 3 years, but rarely up until 4 years [10,11,12,13,14]

  • Our study indicated that 100% eyes reached 20/20 or better in uncorrected distance visual acuity (UDVA) at 7-year follow-up. e efficacy and safety indices were 1.14 ± 0.19 and 1.19 ± 0.20, respectively

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Summary

Introduction

As opposed to flap-based surgical procedures, small incision lenticule extraction (SMILE) is a minimally invasive refractive surgical technique that involves the manual removal of femtosecond laser-created intrastromal lenticule through a small side cut. Numerous clinical studies [3,4,5,6,7,8,9] suggested that SMILE is a safe and effective procedure for myopia correction, and the follow-up periods in these studies mostly spanned from 3 months to 3 years, but rarely up until 4 years [10,11,12,13,14]. In 2019, we [15] have previously compared the 5-year outcomes of SMILE and femtosecond laser-assisted LASIK (FS-LASIK) in patients with myopia. Its long-term safety and efficacy have received enormous attention

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