Incidence and management of intraoperative complications during small-incision lenticule extraction in 3004 cases

PURPOSE: To assess the intraoperative complications during small-incision lenticule extraction (SMILE) for myopia and myopic astigmatism correction and evaluate visual outcomes 6 months postoperatively. SETTING: Tianjin Eye Hospital, Tianjin, China. DESIGN: Retrospective case series. METHODS: Patients who had small-incision lenticule extraction surgery were examined 1 day, 7 days, 1 month, 3 months, and 6 months postoperatively. Demographic characteristics, visual outcomes, and intraoperative complications were recorded. Moreover, the incidence and management of the complications and the potential factors were analyzed. RESULTS: Of the 3004 eyes (1511 patients), 134 (4.46%) had intraoperative complications, including suction loss (28 cases 0.93%), incisional bleeding (28 cases 0.93%), opaque bubble layer (22 cases 0.73%), subconjunctival hemorrhage (20 cases 0.67%), black areas (10 cases 0.33%), unintended posterior plane dissection (10 cases 0.33%), tearing of the lenticule (8 cases 0.27%), abrasion at the incision (5 cases 0.17%), and inaccurate laser pulse placement due to eye movement (3 cases 0.10%). The complications were resolved instantaneously using appropriate management procedures; all cases had good visual outcomes. Six months postoperatively, 99.80% of cases had an uncorrected distance visual acuity better than 20/25 and the mean corrected distance visual acuity was -0.06 logarithm of the minimum angle of resolution ± 0.07 (SD). CONCLUSIONS: Although small-incision lenticule extraction shows promising outcomes for correction of myopia and myopic astigmatism, intraoperative complications still inevitably occur. However, satisfactory visual outcomes may be achieved using appropriate management techniques.