SMILE offers patients successful outcomes through at least a year. Photo: Bobby Saenz, OD, Anthony Vanrachack, OD, and Alexandra Wiechmann, OD.
SMILE offers patients successful outcomes through at least a year. Photo: Bobby Saenz, OD, Anthony Vanrachack, OD, and Alexandra Wiechmann, OD. Click image to enlarge.

A hot topic in the world of refractive surgery, small incision lenticule extraction (SMILE) is a minimally invasive procedure for the correction of myopia and myopic astigmatism that uses one femtosecond laser. Many studies over the years have demonstrated SMILE’s safety and effectiveness, but do these refractive changes remain stable in the months following surgery?

To help determine the efficacy of the procedure after 12 months, a team of investigators completed a non-randomized clinical study on patients (aged 19 to 63) who underwent myopia or myopic astigmatism correction with the SMILE technique using the Zeiss VisuMax Laser system. Patients were examined before surgery and at one, six and 12 months post-op, during which the following were measured: spherical equivalent refraction, cylinder, uncorrected distance visual acuity (UDVA), corrected distance visual acuity and keratometry values.

The cohort included 25 myopic eyes (median of sphere diopters=-4D) and 67 myopic astigmatic eyes (median of cylinder diopters=-1.5D). Not only did the investigators find that UDVA was maintained or improved between the one-month, six-month and 12-month follow-ups, but also that mean refractive spherical equivalent (MRSE) remained stable through a year post-op in all patients.

“At one-month follow-up, we obtained a UDVA equal to or better than 0.5 in 88% of myopic eyes and 82.1% of myopic astigmatic eyes,” the researchers wrote. “At 12 months in 92% of myopic eyes and 85.1% of myopic astigmatic eyes, the UDVA was equal to or better than 0.6.” In addition, “The MRSE in patients with myopic eyes reduced from -4.25D (median) to -0.5D at one month, with a median value of -0.25D at six months and -0.25D at 12 months.”

The data collected in this clinical study adds to growing evidence confirming SMILE to be a reliable refractive corneal procedure with few complications. “SMILE proved an effective and safe refractive procedure and provided a predictable and stable correction of low and moderate myopia and myopic astigmatism,” the investigators concluded.

Nicula CA, Nicula D, Bolboacă SD, Bulboacă AE. One year outcomes after small incision lenticule extraction ReLEX in the correction of myopia and myopic astigmatism. BMC Ophthalmology. 2021;21:423.