15-Month Visual Outcomes and Corneal Power Changes of SMILE in Treating High Myopia With Maximum Myopic Meridian Exceeding 10.00 D.

Abstract

To evaluate the long-term visual and refractive outcomes, optical quality, and stability of the cornea and axial length after small incision lenticule extraction (SMILE) for the correction of high myopia with a maximum myopic meridian exceeding 10.00 diopters (D). Via a prospective cohort study, 53 eyes (53 patients) with a maximum myopic meridian exceeding 10.00 D were corrected with a VisuMax femtosecond laser (version 3.0; Carl Zeiss Meditec AG, Jena, Germany) at the Zhongshan Ophthalmic Center of Sun Yat-sen University. Refractive outcomes, aberrations, axial length, and corneal curvature were evaluated preoperatively and at 1, 3, and 15 months postoperatively. At 15 months postoperatively, the efficacy and safety indexes were 0.91 ± 0.25 and 1.15 ± 0.18, respectively. A total of 72% of eyes were within ±0.50 D and 89% were within ±1.00 D of the attempted spherical equivalent, respectively. From 1 to 15 months postoperatively, the significant regression was -0.24 ± 0.28 D (P < .001) on manifest refraction and -0.43 ± 0.54 D (P < .001) on anterior corneal curvature. In addition, a significant increase of 0.20 µm (P = .016) was observed in the spherical aberration. No significant change was observed in posterior corneal curvature (P > .999), including mean keratometry or astigmatism, or in the ocular axis length from 1 to 15 months postoperatively (26.82 ± 0.93 and 26.82 ± 0.95 mm, respectively, P > .99). SMILE had long-term safety, efficacy, and predictability when treating high myopia with a maximum myopic meridian exceeding 10.00 D. Both a manifest refraction regression of -0.24 D and a significant spherical aberration increase of 0.20 µm were observed between 1 and 15 months postoperatively, due to the increased anterior corneal curvature. [J Refract Surg. 2019;35(1):31-39.].