Objective and Subjective Quality of Vision After SMILE for High Myopia and Astigmatism.

PURPOSE: To report subjective and objective quality of vision (QoV) results for high myopic small incision lenticule extraction (SMILE) between -9.00 and -13.00 diopters (D). METHODS: This was a prospective study recruiting 114 patients undergoing SMILE with attempted spherical equivalent refraction (SEQ) correction from -9.00 to -13.00 D, and cylinder up to 5.00 D. Patients were informed before surgery of the increased risk of QoV symptoms. Patients completed the Rasch validated QoV questionnaire. Objective QoV was assessed by corneal and whole eye aberrations, HD Analyzer Objective Scatter Index (OSI) (Keeler), and contrast sensitivity. Patient satisfaction was assessed on a scale from 0 (very dissatisfied) to 10 (very satisfied). Individual item and total Rasch-scaled scores for the three subscales (frequency, severity, and bothersomeness) of the QoV questionnaire were calculated before and 12 months after surgery. RESULTS: The mean patient satisfaction score was 9.27 ± 1.18 (range: 2 to 10), 8 or higher in 93%, and 7 or higher in 98% of patients. One patient with a satisfaction score of 2 had a simple refractive error re-treatment and then reported a satisfaction score of 10. The total mean ± standard deviation Rasch-scaled QoV score for the frequency, severity, and bothersomeness subscales before surgery was 24 ± 19, 20 ± 16, and 19 ± 18, respectively. Scores increased after surgery to 41 ± 18, 32 ± 16, and 30 ± 21, respectively (P < .001). Corneal aberrations (6 mm, OSI) increased on average by 0.39 µm for spherical aberration, 0.41 µm for coma, and 0.56 µm for higher order aberrations root mean square. OSI increased on average by 0.58. There was a small but statistically significant improvement in contrast sensitivity at 3, 6, 12, and 18 cycles per degree. There were no statistically significant correlations found between subjective scores for starbursts and objective measurements. CONCLUSIONS: Satisfaction was high following SMILE for high myopia. As expected, there was an increase in QoV symptoms, mainly glare and starbursts. The acceptance of QoV symptoms for high myopic SMILE was high, indicating that residual refractive error and visual acuity are the major drivers for patient satisfaction with appropriate preoperative informed consent. [J Refract Surg. 2022;38(7):404-413.].

Small Incision Lenticule Extraction (SMILE) for the Correction of High Myopia With Astigmatism.

PURPOSE: To report the outcomes of small incision lenticule extraction (SMILE) for high myopia between -9.00 and -14.00 diopters (D). METHODS: This was a prospective study of SMILE for high myopia using the VisuMax femtosecond laser (Carl Zeiss Meditec). Inclusion criteria were attempted spherical equivalent refraction (SEQ) between -9.00 and -14.00 D, cylinder up to 7.00 D, corrected distance visual acuity (CDVA) of 20/40 or better, age 21 years or older, and suitable for SMILE. The sub-lenticule thickness was 220 µm or greater, and the total uncut stromal thickness was 300 µm or greater. Patients were to be followed up for 1 year. Standard outcomes analysis was performed using 12-month data where available or 3-month data otherwise. RESULTS: Of 187 eyes treated, data were available at 12 months for 181 eyes (96.8%) and 3 months for 4 eyes (2.1%), and 2 eyes (1.1%) were lost to follow-up. Mean attempted SEQ was -10.55 ± 1.00 D (range: -9.00 to -12.99 D). Mean cylinder was -1.19 ± 0.83 D (range: 0.00 to -4.00 D). Preoperative CDVA was 20/20 or better in 73% of eyes. Postoperative uncorrected distance visual acuity was 20/20 or better in 57% and 20/25 or better in 82% of eyes. Mean SEQ relative to target was -0.22 ± 0.48 D (range: -1.63 to +1.38 D), 66% ± 0.50 D and 93% ±1.00 D. Mean SEQ 12-month change was -0.08 ± 0.34 D (range: -1.75 to +0.88 D). There was loss of one line of CDVA in 4% of eyes, and no eyes lost two or more lines. Contrast sensitivity was unchanged. Patient satisfaction was 8 or more out of 10 in 94% and 6 or more in 99% of patients. CONCLUSIONS: Outcomes of SMILE for myopia greater than -9.00 D at 3 to 12 months showed excellent efficacy, safety, stability, and predictability, with high patient satisfaction. [J Refract Surg. 2022;38(5):262-271.].