Einfluss intraoperativer Interface-Spülung nach Small Incision Lenticule Extraction (SMILE) auf Effektivität, Sicherheit und Komplikationshäufigkeit

Small incision lenticule extraction (SMILE) has become established in the field of refractive surgery since 2011 und has been advanced continuously since then. Aim of this study was to investigate the outcome differences of interface flushing with balanced salt solution (BSS) after the removal of the refractive lenticule in uncomplicated bilateral simultaneous SMILE. For this purpose, we performed a prospective randomized single-blinded interventional contralateral eye study in six centers within the SMILE EYES Group in Germany. 257 patients with myopia and myopic astigmatism of similar magnitude in both eyes (spherical equivalent (SE) ≤ 10 D, preoperative best-corrected distance visual acuity (CDVA) of 0.8 decimal or better and anisometropia ≤ 2 D) were enrolled and followed-up for 3 months. One eye of each patient was treated with interface-flushing after dry extraction of the lenticule. Flushing was performed with 1 cc BSS using a 27-gauge single-use canula. Uncorrected distance visual acuity (UDVA) at day 1, 1 week and 3 months and CDVA at 3 months were recorded along with any postoperative differences at the slit-lamp-examination. Statistical analyses were performed with logMAR values using paired t-tests. The p-value for significance was set at < 0.050. Data of 470 eyes were analyzed. At the first postoperative day, UDVA (decimal) was 0.81 in the non-flush and 0.83 in the flush group, respectively (p = 0.110). At the last visit, 3 months post-op, UDVA (decimal) was 1.04 in the non-flush and 1.05 in the flush group, respectively (p = 0.172). No significant differences in the rate of postoperative complications could be found. In conclusion, interface irrigation with 1 cc of BSS after the removal of the refractive lenticule in SMILE has neither advantages nor disadvantages in terms of visual recovery, postoperative complications or final visual acuity.