Postoperative Corneal Complications in Small Incision Lenticule Extraction: Long-Term Study

PURPOSE: To investigate the incidence and clinical results of corneal complications after small incision lenticule extraction (SMILE). METHODS: A retrospective cohort study including 3,223 patients (6,373 eyes) who were treated for myopia or myopic astigmatism was conducted. Postoperative corneal complications were recorded. Postoperative follow-up visits were scheduled on days 1 and 7 and months 1, 3, 6, and 12. RESULTS: Of the 6,373 cases, 432 eyes (6.8%) developed at least one corneal complication postoperatively. These included punctate epithelial erosions (3.26%), diffuse lamellar keratitis (DLK) (2.17%), corneal infiltrates (0.39%), interface debris/secretion (0.30%), interface haze (0.17%), interface foreign body (0.24%), corneal striae (0.14%), corneal edema (0.09%), and epithelial ingrowth (0.02%). Of cases with corneal complications, 308 (71.3%) had an uncorrected distance visual acuity (UDVA) of better than 20/25 and 49 (11.3%) eyes lost two or more lines of corrected distance visual acuity (CDVA) on the first day after surgery. By 3 months, only 2 eyes (0.9%) had lost two or more lines of CDVA. At 6 months, 1 eye (1.0%) did not achieve a UDVA of 20/25 as a result of stage 3 DLK, but achieved 20/20 by 1 year. The postoperative spherical equivalent in cases without complications was lower than that in cases with complications at 1 day and 1 and 3 months (P = .001, .011, and .001, respectively), but there was no statistical difference at 6 and 12 months. CONCLUSIONS: In this large cohort study, a variety of corneal complications were noted after SMILE. Although some of these complications may temporarily affect visual recovery, most resolve with appropriate treatment.