A few other clinics have observed patients close to the 5-year mark and they have found similar results. Han, et al. investigated the long-term refractive outcomes, wavefront aberrations and quality of life after SMILE in patients with moderate to high myopia.
Twenty-six patients (47 eyes) with a preoperative mean SE of -6.30 ± 1.47 D underwent SMILE. Measurements included UDVA, CDVA, manifest refraction, wavefront aberrations and quality of life. At 4 years postoperatively, UDVA was better than or equal to 20/20 in 92% of eyes.
The efficacy index was 1.07 ± 0.16, and 89% of eyes were within ± 0.5 D of the intended refractive target. No eyes lost Snellen lines, and the safety index was 1.16 ± 0.14. There were no significant changes of SE during postoperative evaluations at 1, 3 and 6 month visits or 1, 2 and 4 year visits.
HOA, coma and spherical aberration all increased postoperatively, and there were no significant changes of aberrations detected in the 37 eyes that were analysed at 1-month, 6-month or 4-year follow-ups. Furthermore, those who underwent SMILE revealed a significantly higher score on quality of life than those in the spectacle group (45.71 ± 2.61 versus 39.96 ± 3.56, P < 0.001).3
In the first long-term study of SMILE, Blum et al. also evaluated the 5-year results of SMILE in patients with myopia and myopic astigmatism. In 2008 and 2009, 91 eyes were treated. Fifty-six out of 91 eyes of the original treatment group volunteered for re-examination 5â years after surgery. UDVA and CDVA were measured after 5â years along with objective and manifest refractions.
They also evaluated the interface and corneal surface by slit lamp examination and documented complications, such as corneal scars, corneal ectasia, persistent dry eye symptoms or cataract. After 5 years, there were no significant changes to the 6-month data. SE was -0.375â D and close to target refraction (emmetropia).
Thirty-two of the 56 eyes had gained one to two Snellen lines, but there was no loss of two or more lines over the 5-year period. Long-term regression was recorded at 0.48 D. SMILE proved to be an effective, stable and safe procedure for the treatment of myopia and myopic astigmatism.4