Incidence of Ectasia After SMILE From a High-Volume Refractive Surgery Center in India

To report the incidence of ectasia after small incision lenticule extraction (SMILE) in a high-volume refractive surgery center in India.

To derive the incidence of ectasia after SMILE, all eyes that underwent SMILE or SMILE Xtra (SMILE combined with prophylactic accelerated corneal cross-linking) from November 2012 to August 2019 were retrospectively analyzed. Furthermore, these cases were classified as being "normal" or "borderline" based on certain predefined criteria. Only eyes with a minimum follow-up of 12 months were included.

Of the total 7,024 eyes analyzed, 6,619 eyes underwent SMILE, of which 10 eyes developed ectasia at a mean interval of 21.3 months, making the incidence of ectasia after SMILE 0.15%. Of these 10 eyes with ectasia, 2 eyes had normal preoperative topography, whereas the remaining 8 eyes were borderline as per the predefined criteria. Retrospective data analysis revealed that 6,025 of 7,024 eyes were normal and thus suitable for a standard SMILE procedure, whereas 999 eyes were borderline, of which 594 eyes underwent SMILE and 405 eyes underwent SMILE Xtra. The incidence of ectasia in borderline eyes undergoing SMILE was 0.80% (8 of 999) versus 0% (none) for borderline eyes undergoing SMILE Xtra (chi square, P < .05).

The incidence of ectasia after SMILE in the early postoperative period was 0.15%, with borderline eyes accounting for most cases. Borderline eyes treated with SMILE Xtra did not progress to ectasia, potentially suggesting a protective role of simultaneous CXL. [.