The purpose of our most recent investigation was to report the 5-year results of patients by evaluating the first 42 fully seeing eyes treated with SMILE for myopia and myopic astigmatism in 2011 and 2012. We analysed stability, safety, efficacy and predictability, and as an added component we explored the patient’s subjective satisfaction with the treatment.
This prospective clinical trial comprised 100 eyes from 50 patients who underwent SMILE in 2011 and 2012. The mean age was 29 years with 79% being female and 21% male. Preoperatively, the patients had a mean SE of -4.56 D ±1.29 D, a mean sphere of -4.36 D ±1.31 D and a mean cylinder of -0.41 D ±0.51 D.
The technique and parameters for the laser included topical anaesthesia, a scanning direction for the bottom of the lenticule from the periphery to the centre, and a “cap” that was created from the centre to the periphery. The optical zone was from 6 to 7 mm, and the cap diameter was 0.5-1 mm more than the lenticule.
Minimal thickness was 15 Ð¼Ðº and the cap thickness was 120 Ð¼Ðº. Residual stroma was at least 300 Ð¼Ðº, and the incision width was 3 to 4 Ð¼Ð¼. Follow-up occurred at 1 day; 1 week; 1 month; 3 months; 6 months; 12 months; and subsequently, 5 years.
At the 5-year follow-up, 42 eyes from 21 patients were available. We found that the mean sphere moved from -0.15 to -4.35 and spherical equivalent was -0.23 from a range of 0.38 to -0.35. There was minimal degradation.
When we looked further into this we found that 10 of 32 eyes had a small progression of myopia while the other eyes were stable. Topography revealed no changes, and emmetropia was in between 0.25 D in 71% of patients.
At the 12-month visit as well as the 5-year visit, visual acuity remained at 90%. BCVA was high at 4.8% in 2012, and in 5 years no patient lost any Snellen lines, which was better than 1, 3, 6, and 12 months; 12% gained two lines in 5 years. The results of the patient questionnaire reflected that 40% of patients experienced glare, 55% experienced a slight problem with night driving, and 95% found that their vision had significantly improved.