Small Incision Lenticule Extraction

(SMILE)
Original article Joshua Harvey, Hideki Fukuoka, MD, PhD, Natalie Afshari, MD
contributed by: FACS
All contributors: Brad H. Feldman, M.D. and Hideki Fukuoka, MD, PhD
Assigned editor: Hideki Fukuoka, MD, PhD
Assigned status Up to Date by Hideki Fukuoka, MD, PhD,
Review:
Joshua Harvey, Natalie Afshari, MD on April 30, 2015.

Contents
1 Introduction
o 1.1 Background/Overview
o 1.2 Surgical Technique & History of Procedure
o 1.3 Outcomes
o 1.4 Complications
o 1.5 Conclusions
o 1.6 References

Introduction
Small incision lenticule extraction (SMILE) is a relatively new refractive procedure designed
to treat a multitude of refractive errors such as myopia, hyperopia, presbyopia, and
astigmatism. The procedure involves using a femtosecond laser to create a corneal lenticule
which is extracted whole through a small incision without the use of an excrimer laser. It is
reported to achieve effects similar to laser-assisted in situ keratomileusis (LASIK) with
excellent post-operative outcomes.

Background/Overview
Starting in 2007, an intrastromal lenticule method was reintroduced as an alternative to
LASIK called Femtosecond Lenticule Extraction (FLEx) intended for patients with extreme
myopia. After improvements to scan modes and energy parameters, improved visual recovery
times were noted, with refractive results similar to LASIK. Following the implementation of
FLEx, a procedure called small incision lenticule extraction (SMILE) was developed,
involving a small 2-3 mm incision used to allow for extraction of the whole corneal lenticule
without the need to create a flap.[1]

While still in its early stages of proclivity amongst surgeons, SMILE is noted for achieving
similar effects as LASIK but with some possible benefits such as faster recovery of post-op
dry eye, reinnervation of corneal nerves, and a potential biomechanical advantage. The
commencement of this procedure began in September 2011 and is established in various
locations such as Europe, China and India. The clinical trial in the USA began in June 2012
and has been expanded by the US FDA after initial signs of success in a small sample of
patients. To date, 255 patients have been treated at five centers in the USA. Outside of the
USA, there are 150 centers in a total of 38 countries that perform the procedure.[2]

Surgical Technique & History of Procedure

During the SMILE procedure, the patient is raised to the contact glass of the femtosecond
laser and suction ports are activated to keep the patient's eye fixated in the correct position
while the lenticule is created. The lower interface of the intrastromal lenticule is created first
(using an out-to-in direction with the laser to maximize the time without blurring the patients
central vision), followed by the upper interface of the lenticule (using an in-to-out direction),
known as the cap, and finally a 23 mm tunnel incision (usually supero-temporal) that links
the cap interface to the corneal surface. To avoid any undesirable effects in the cornea such as
haziness, the two interfaces (lower and upper) are created from the endothelial side of the
cornea to the epithelial side. The patient is then moved to the surgical microscope for the
lenticule separation and extraction part of the procedure. The layers of the lenticule are
outlined and the lenticule is removed from the cornea using a pair of retinal micro-forceps, or
can be extracted directly from within the pocket with the latest versions of the lenticule
stripper, one of many instruments being developed for the SMILE procedure specifically.[3]

When planning the treatment, the following parameters can be selected by the surgeon: cap
thickness, cap diameter, cap sidecut angle, refractive correction, lenticule diameter (optical
zone), lenticule sidecut angle, and the minimum lenticule thickness (so that the lower
lenticule interface can be easily differentiated from the upper interface).
Outcomes
The efficacy and safety of SMILE at the time of its introduction had yet to be established, but
studies have since elaborated on these aspects. In a group consisting of 88 eyes, Ang et al.
(2014) found that 95.5% of the eyes were within 1.00 D of the attempted correction and
78.4% were within 0.50 D of the attempted correction. Additionally it was found that
uncorrected visual distance acuity (UDVA) of 20/40 or better was seen in 100% of eyes at 3
month post-op and 76.5% were 20/20 or better, up to 12 months post-op.[4] Continuing, it was
determined that there was no significant difference between the efficacy, predictability, or
safety between low myopia eyes and eyes of -5.00 D or greater, highlighting the large span of
cases that this procedure has the potential to improve. Because the incision is so minimal, the
possibility of another treatment after SMILE is possible due to the cornea being left mostly
intact. Another possibility being examined is the use of the lenticule for re-implantation after
being cryopreserved, which has been successfully performed in rabbits.[5][6]

Complications
Complications arising during the SMILE procedure have been reported very infrequently,
supporting the reported safety and predictability of the procedure. Studies using SMILE
found epithelial abrasions, small tears at the incision, and perforated caps in few cases,
however, none of these patients had late visual symptoms.[7] The loss of suction during the
femtosecond laser portion of the procedure is one of the primary complications with SMILE,
and seems to be a difficult topic to define care that applies to most or all cases. While noted
to be very infrequent, one study showed the majority of cases in which suction loss occurred
were able to be reapplied in the same setting(81.8%). [8]
The rest of the suction loss cases were aborted, though, it should be noted that for all cases
involving suction-loss, there remained a significant number of patients that attained UDVA
within attempted correction. Because a small incision (2-3 mm) is used in place of an entire
flap, corneal nerve severance is minimal in comparison to LASIK. This coincides with the
decreased occurrence of post-operative dry eye and studies have indeed shown an increase in
nerve reinnervation after treatment. In a study by Xu et al. comparing dry eye parameters
between SMILE and LASIK, all paramaters were found to be worse in the early
postoperative period for both groups, however the SMILE group showed better scores in tear
break up time, the McMonnies score, and Schirmers test.[18] These findings by Xu et al.
coincide with similar results from a study by Denoyer et al. [5]which found high rates of dry
eye symptoms for both procedures reported one month after surgery, but at 6 months after
surgery, 80% of SMILE patients finished using any eye drops in contrast to only 57% of the
patients in the LASIK group who did the same.

Conclusions
The SMILE procedure, while still in its early stages, seems to be a promising alternative to
LASIK in some cases. Given its flapless technique and results that appear to be similar to
LASIK, it may offer the same correctional abilities with the potential benefits of faster
recovery of post-op dry eye, quicker reinnervation of corneal nerves, and biomechanical
advantages. After clinical trials are completed for SMILE and pending its approval, this
procedure may be an upcoming option for some patients, due to its minimally invasive
technique and promising outcomes.

References
Reinstein et al.: Small incision lenticule extraction (SMILE) history, fundamentals of a
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Mar. 2015. http://www.eandv.org/content/pdf/s40662-014-0003-1.pdf
"Innovative SMILE Procedure from ZEISS Successfully Performed on More than
80,000 Eyes." Innovative SMILE Procedure from ZEISS. ZEISS, 04 Feb. 2014. Web. 10
Mar. 2015. http://www.zeiss.com/content/dam/Meditec/downloads/pdf/press-
releases/czm_pi_smile_80000_procedures_20140204_en.pdf
Liu Y-C, Pujara T, Mehta JS (2014) New Instruments for Lenticule Extraction in Small
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Ang et al. : Refractive lenticule extraction: Transition and comparison of 3 surgical
techniques Journal of Cataract & Refractive Surgery , Volume 40 , Issue 9 , 1415 1424
Denoyer et al. : Dry Eye Disease after Refractive Surgery: Comparative Outcomes of
Small Incision Lenticule Extractionnversus LASIK, Ophthalmology, Available online 22
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