One year outcomes after small incision lenticule extraction ReLEX in the correction of myopia and myopic astigmatism

PURPOSE: To report the visual and refractive outcomes of small incision lenticule extraction ReLEX (SMILE) technique using VisuMax femtosecond laser in myopia and myopic astigmatism patients. MATERIAL AND METHODS: A non-randomized clinical study has been conducted on patients with myopia and myopic astigmatism who underwent ReLEX SMILE technique, using the Zeiss VisuMax Laser system (Carl Zeiss Meditec AG, Jena, Germany) at Oculens Clinic, Cluj-Napoca, Romania. Patients older than 18 years, with ocular astigmatism up to -5 diopters (D), spherical equivalent up to -10.00 D, corrected distance visual acuity (CDVA) of 0.3 or better before the surgery, stable refraction for one year, and with a minimum calculated post operator residual stromal bed of 250μ were included in the study. RESULTS: The study involved a total of 25 myopic eyes (median of sphere diopters equal with -4D) and 67 myopic astigmatic eyes (median of cylinder diopters equal with -1.5 D). The mean refractive spherical equivalent (MRSE) on patients with myopic eyes reduced from -4.25D (median) to -0.5D at one month follow-up, -0.25 D at 6 and 12 months. The mean refractive spherical equivalent (MRSE) on patients with astigmatic myopic eyes reduced from-6.25 D to -0.67 D at one month, -0.62 D at six and twelve months. The value of sphere decreased postoperatively on myopic eyes with a median of -0.25D at one, six and twelve months. The value of cylinder decreased postoperatively on myopic astigmatic eyes with a median of -0.50 D at one month, -0.25 D at six months and -0.50 D at 12 months. At 6 and 12 months, 20 (80.0%) of myopic eyes were maintained within ±0.5 D and 22 (88.0%) with ±1D. On both groups (myopic eyes and myopic astigmatic eyes), statistically significant differences were observed when the keratometric baseline values were compared to each follow-up (P-values < 0.0001), without any significant differences between follow-ups (P-values>0.15). At 1-month follow-up, uncorrected distance visual acuity (UDVA) was better than or equal to 0.5 in 88.0% of myopic eyes and 82.1% of myopic astigmatic eyes. UDVA remained stable in all cases of myopic eyes at six months and the percentage increased at 92.0% in myopic eyes. UDVA slightly increased at 6-months (85.1%) and remained at the same value at 12-months in myopic astigmatism eyes. CONCLUSIONS: SMILE proved an effective and safe refractive corneal procedure and provided a predictable and stable correction of myopia and myopic astigmatism. SMILE technique demonstrated very good outcomes in terms of keratometric, cylinder, spherical measurements.