My colleagues and I were included in the first investigative clinical trial of SMILE in 2011, wherein we reported the 1-year refractive results, contrast sensitivity, higher-order aberrations (HOA) and complications after SMILE. We evaluated 54 eyes of 27 patients who had a mean spherical equivalent of -4.68 ± 1.29 D and who underwent SMILE by the same surgeon using a femtosecond laser system (Visumax, Carl Zeiss Meditec AG).
We followed these patients for 1 year beginning with follow-up visits at 1 day, 1 week, and 1, 3, 6 and 12 months postoperatively. Our parameters were uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA), contrast sensitivity and wave front measurements, in addition to recording all complications.
Suction loss occurred in one eye during the procedure, so we were able to gather the 12-month results on 53 eyes. After 1 year, 88% of eyes with plano target had a UDVA of 20/20 or better. Twelve percent of eyes lost one Snellen line of CDVA, 31% gained one Snellen line and 3% gained two Snellen lines.
The mean spherical equivalent (SE) after 1 year was -0.19 ± 0.19, while the mean refraction change between month one and 12 was 0.08 D. We did not observe any visually threatening complications. In this first cohort of SMILE patients, the refractive results were satisfactory.2