Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes

Dan Z Reinstein, Timothy J Archer, Marine Gobbe, Dan Z Reinstein, Timothy J Archer, Marine Gobbe

Abstract

This review summarizes the current status of the small incision lenticule extraction (SMILE) procedure. Following the early work by Sekundo et al. and Shah et al., SMILE has become increasingly popular. The accuracy of the creation of the lenticule with the VisuMax femtosecond laser (Carl Zeiss Meditec) has been verified using very high-frequency (VHF) digital ultrasound and optical coherence tomography (OCT). Visual and refractive outcomes have been shown to be similar to those achieved with laser in situ keratomileusis (LASIK), notably in a large population reported by Hjortdal, Vestergaard et al. Safety in terms of the change in corrected distance visual acuity (CDVA) has also been shown to be similar to LASIK. It was expected that there would be less postoperative dry eye after SMILE compared to LASIK because the anterior stroma is disturbed only by the small incision, meaning that the anterior corneal nerves should be less affected. A number of studies have demonstrated a lower reduction and faster recovery of corneal sensation after SMILE than LASIK. Some studies have also used confocal microscopy to demonstrate a lower decrease in subbasal nerve fiber density after SMILE than LASIK. The potential biomechanical advantages of SMILE have been modeled by Reinstein et al. based on the non-linearity of tensile strength through the stroma. Studies have reported a similar change in Ocular Response Analyzer (Reichert) parameters after SMILE and LASIK, however, these have previously been shown to be unreliable as a representation of corneal biomechanics. Retreatment options after SMILE are discussed. Tissue addition applications of the SMILE procedure are also discussed including the potential for cryo-preservation of the lenticule for later reimplantation (Mohamed-Noriega, Angunawela, Lim et al.), and a new procedure referred to as endokeratophakia in which a myopic SMILE lenticule is implanted into a hyperopic patient (Pradhan et al.). Finally, studies reporting microdistortions in Bowman's layer and corneal wound healing responses are also described.

Keywords: Cap; Corneal biomechanics; Corneal innervation; Corneal sensation; Dry eye; Endokeratophakia; Laser in situ keratomileusis (LASIK); Lenticule; Small incision lenticule extraction (SMILE).

Figures

Figure 1
Figure 1
Incision geometry of the SMILE procedure. The lenticule cut (1) is performed (the underside of the lenticule), followed by the lenticule sidecuts (2). Next, the cap interface (3) is created (the upper side of the lenticule), and finally a 2–3 mm small incision (4) is created supero-temporally. The lenticule interfaces are dissected using a flap separator and the lenticule is extracted manually, all via the small incision.
Figure 2
Figure 2
Line graph showing the mean central corneal sensation over the 12-month follow-up period averaged across 7 SMILE studies and 16 LASIK studies following a review of the peer-reviewed literature.
Figure 3
Figure 3
Scatter plot of the percentage of maximum cohesive tensile strength against the percentage of residual stromal depth using data from the study by Randleman et al. [66]. A fourth order polynomial regression line was fit to the data and this equation was integrated to calculate the area under the curve for the relevant stromal depths after photorefractive keratectomy (PRK), laser in-situ keratomileusis (LASIK), and small incision lenticule extraction (SMILE) as demonstrated by the green shaded regions. The red areas represent the tissue removed (excimer laser ablation/lenticule extraction) and the purple area in LASIK represents the LASIK flap. Reprinted with permission from [71].

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