Ten-year outcomes following small incision lenticule extraction for up to -10Dioptres myopia

ABSTRACT

Clinical relevance

More than 6 million small-incision lenticule extraction (SMILE) procedures have been performed worldwide since 2011. Therefore, its long-term safety and efficacy should be investigated.

Background

This study aimed to evaluate 10-year refractive outcomes, corneal stability, axial length, and wavefront aberrations in patients who underwent SMILE to correct myopia.

Methods

Thirty two patients (32 eyes) who underwent SMILE-based myopic correction. Corrected distance visual acuity, uncorrected distance visual acuity, corneal stability, axial length, and wavefront aberrations were evaluated preoperatively and at 1 month and 1, 5, and 10 years postoperatively.

Results

At 10 years postoperatively, the safety and efficacy indices for the patients included in this study were 1.19 ± 0.21 and 1.04 ± 0.27, respectively. For 26 (81%) and 30 eyes (94%), correction to within ±0.50 D and ±1.00 D of the target was achieved, respectively. Over the 10-year follow-up duration, a mean −0.32 ± 0.56 D regression was observed (−0.03 ± 0.06 D/year). Relative to baseline, horizontal and vertical comas significantly increased, as did the incidence of higher-order aberrations (all P < 0.001), whereas axial length and corneal elevation remained stable during follow-up.

Conclusion

These results indicate that the SMILE-based correction for myopia of up to -10 Dioptres is safe, effective, and stable, with relatively constant wavefront aberrations and corneal stability over time after treatment.

KEYWORDS:

• Myopia
• small incision lenticule extraction
• ten-year outcomes

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

National Natural Science Foundation of China [Grant No. 81770955]; Project of Shanghai Science and Technology [Grant No. 20410710100]; Clinical Research Plan of SHDC [SHDC2020CR1043B]; Project of Shanghai Xuhui District Science and Technology [2020-015]; Project of Shanghai Xuhui District Science and Technology [XHLHGG202104]; Shanghai Engineering Research Center of Laser and Autostereoscopic 3D for Vision Care [20DZ2255000]; Construction of a 3D digital intelligent prevention and control platform for the whole life cycle of highly myopic patients in the Yangtze River Delta [21002411600].