Офтальмохирургия (Oct 2017)
ReLEx® SMILE TECHNOLOGY – EVOLUTION OF SURGICAL CORRECTION OF MYOPIA
Abstract
Purpose. To study results of the ReLEx® SMILE operation to correct myopia and myopic astigmatism at a two-year follow-up. Material and methods. The SMILE surgery was performed in the patients of the main group for a correction of myopia with the sphere up to 10.0D and myopic astigmatism up to 4.0D (390 eyes – 200 patients), of them 80 male (40% ) and 120 female (60%). The study had two control groups: LASIK (166 eyes, 86 patients) and PRK (122 eyes, 62 patients). In the main group, the age of patients ranged from 18 to 54 years (29.7±5.9 years). The follow-up was up to 2 years. BCVA was from 0.7 to 1.2 (0.97±0.12). The central corneal thickness (according to US-keratopachymetry) was from 468 to 654 microns. The horizontal diameter of the cornea was from 11.2 to 12.9mm (12.0±0.5mm). The preoperative characteristics of the eyes in the control groups were similar. Results. Already 1 month after the SMILE and LASIK operations, UCVA was 1.0 and higher and remained stably high during the entire two-year follow-up. After PRK, the recovery rate of UCVA was statistically significantly lower in the first 3 months after surgery (p<0.001), and then significantly increased and approached that after SMILE and LASIK operations. The UCVA in the distance 2 years after the SMILE and LASIK technologies was higher than after the PRK operation (statistically significant difference: p><0.005). In this period a slightly higher UCVA at distance was noted after the LASIK operation (1.06±0.26) than after the SMILE surgery (1.04±0.28), but this difference was statistically unreliable (p=0.142). In 2.3% of all SMILE operations, insignificant complications were noted that were completely curable and was not affect the recovery and restoration of visual acuity of patients. The SMILE operation was repeated next day in 1 eye with the loss of vacuum. Most complications were revealed during the phase of surgical development and mastering the SMILE surgery in the first 20 patients.>< 0.001), and then significantly increased and approached that after SMILE and LASIK operations. The UCVA in the distance 2 years after the SMILE and LASIK technologies was higher than after the PRK operation (statistically significant difference: p< 0.005). In this period a slightly higher UCVA at distance was noted after the LASIK operation (1.06±0.26) than after the SMILE surgery (1.04±0.28), but this difference was statistically unreliable (p=0.142). In 2.3% of all SMILE operations, insignificant complications were noted that were completely curable and was not affect the recovery and restoration of visual acuity of patients. The SMILE operation was repeated next day in 1 eye with the loss of vacuum. Most complications were revealed during the phase of surgical development and mastering the SMILE surgery in the first 20 patients. Conclusion. The SMILE technology is a safe and effective keratorefractive operation for the correction of myopia with spherical equivalent from 1.0D to 12.0D. The SMILE technology is characterized by a rapid restoration of UCVA and minimal postoperative corneal syndrome, as in LASIK, and at the same time there is no superficial flap of the cornea, as in the PRK operation. The highest UCVA in the distance is noted after the SMILE technology in long-term two-year follow-up period in comparison with the standard operations of LASIK and PRK.
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