“Small Incision Lenticule Extraction (SMILE)”

Lecturer Advicers :
dr. Agah Gadjali, SpM
dr. Hermansyah, SpM
dr. Henry A. W, SpM
dr. Gartati Ismail, SpM
dr. Mustafa K. Shahab, SpM

By:
Arum Sekar Latih (1102012029)
Chairunnisa Rifka Windiputri (1102012044)
Ibramu Al Furqan (1102012115)
Relanfa Farando (1102012234)

OPTHALMOLOGY DEPARTEMENT
BHAYANGKARA TK.1 R.S. SUKANTO HOSPITAL
16 OCTOBER - 17 NOVEMBER 2017
YARSI UNIVERSITY
MEDICAL SCHOOL
 CHAPTER I
INTRODUCTION

In the original  keratomileusis  procedure for myopia, an approcimately  300

mm   thick   disc   was   dissecred   from   the   anterior   cornea   in   a   freehand   fashion   and
reshaped   using   a   cryolathe.   In   the   late   1980's,   Ruiz   developed   an   automated
microkeratome that controlled speed as it passed across the cornea, this procedure has
become   known   as   automated   lamellar   keratoplasty   (ALK).   In   the   1990's   the
combination   of   a   icrokeratome   and   an   excimer   laser   (for   the   refractive   cut)   was
developed by Pallikaris, Burato and others, for improving the predictability of the
refractive  procedure,  this  procedure known as laser assisted in situ keratomileusis
(LASIK).   LASIK   has   gained   wide   acceptance   worldwide.   Recently,   femtosecond
lasers   have   become   available   for   the   cutting   of   the   intrastromal   lenticule   and
subsequent lenticuler extraction. In the femtosecond­only technique for correction of
refractive   errors   (femtosecond   lenticule   extraction),   the   intrastromal   lenticule   is
removed using flap­like access. In small incision lenticule extraction (SMILE), the
incision is minimized and the procedure does not use a flap. SMILE is a fairly new
procedure   of   corneal   refractive   surgery.   Recent   publications,   including   up   to   150
patients,   suggest   that   this   femtosecond   laser   flap­free   refractive   procedure
demonstrates predictability, safety, and efficacy similar to that of femtosecond laser–
assisted LASIK. 

The patients underwent the SMILE technique were to correct their refractive
defects.  The clinical manifestation myopia < 8 diopters (D), astigmatism < 2 D and <
20/30 best­ spectacle corrected visual acuity (BSCVA) with glasses or contact lenses;
contact   lens   intolerance;   regular   cornea   without   ectasia   as   assessed   by   Orbscan
corneal topography, Intraocular pressure (IOP) within normal limits (with or without
hypotensive drops); absence of retinal disease; and a minimum follow­up period of
three   months.   There   are   relative   and   absolute   contraindications.   Relative
contraindications   are   mild   dry   eyes,   recurrent   corneal   erosions,   history   of   herpes
simplex   keratitis,   atopic   disease,   glaucoma,   and   pregnancy.   The   absolute
contraindications are unstable refractiin, abnormal or irregular topography, significant
corneal scarring, and uncontrolled systemic or ocular disease.

SMILE provides good outcomes in terms of refraction as well as additional
benefits, such as a reduction in scatter that leads to better vision quality. Despite the
proven efficacy of LASIK, it still requires the use of two machines: one for the flap
creation and another for Excimer ablation. This increases costs as well as the surgical
time for the procedure. SMILE uses only one laser machine, thus potentially reducing
surgical time and cost. Moreover, SMILE does not involve any flap creation, which
potentially   reduces   risk   of   side   effects   such   as   dry   eyes   and   other   flap   related

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complications. Unlike LASIK which uses an excimer laser to ablate corneal tissue,
SMILE   cuts   and   removes   a   piece   of   corneal   lenticule,   which   may   be   stored   and
replaced into the cornea later on. This is important as we can potentially reverse the
refractive procedure many years later when the patient’s myopia decreases.

3
 CHAPTER II
ANATOMY AND PHYSIOLOGY

Anatomi

The cornea is the transparent front part of the eye that covers the iris, pupil,
and anterior chamber. The cornea, with the anterior chamber and lens, refracts light,
with the cornea accounting for approximately two-thirds of the eye's total optical
power. In humans, the refractive power of the cornea is approximately 43 dioptres.
While the cornea contributes most of the eye's focusing power, its focus is fixed.
The curvature of the lens, on the other hand, can be adjusted to "tune" the focus
depending upon the object's distance.

Structure
The cornea has unmyelinated nerve endings sensitive to touch, temperature
and chemicals; a touch of the cornea causes an involuntary reflex to close the eyelid.
Because transparency is of prime importance, the cornea does not have blood vessels.
Instead, oxygen dissolves in tears and then diffuses throughout the cornea to keep it
healthy. Similarly, nutrients are transported via diffusion from the tear fluid through
the outside surface and the aqueous humour through the inside surface, and also
from neurotrophins supplied by nerve fibres that innervate it. In humans, the cornea
has a diameter of about 11.5 mm and a thickness of 0.5–0.6 mm in the center and 0.6–
0.8 mm at the periphery. Transparency, avascularity, the presence of immature
resident immune cells, and immunologic privilegemakes the cornea a very special
tissue. The most abundant soluble protein in mammalian cornea is albumin.
The human cornea borders with the sclera via the corneal limbus. In lampreys,
the cornea is solely an extension of the sclera, and is separate from the skin above it,
but in more advanced vertebrates it is always fused with the skin to form a single
structure, albeit one composed of multiple layers. In fish, and aquatic vertebrates in
general, the cornea plays no role in focusing light, since it has virtually the
same refractive index as water.
Although the cornea may look clear and seem to lack substance, it is a highly
organized tissue. Unlike most tissues in the body, the cornea contains no blood vessels
to nourish or protect it against infection. Instead, the cornea receives its nourishment
from tears and the aqueous humor.
The tissues of the cornea are arranged in three basic layers, with two thinner layers, or
membranes, between them. Each of these five layers has an important function. These
layers are:

4
 a) Epithelium
The epithelium is the cornea’s outermost layer. Its primary functions are to:
1. block the passage into the eye of foreign material, such as dust, water, and
bacteria; and
2. provide a smooth surface to absorb oxygen and nutrients from tears, which are
then distributed to the other layers of the cornea.

The epithelium is filled with thousands of tiny nerve endings, which is why your eye
may hurt when it is rubbed or scratched. The part of the epithelium that epithelial cells
anchor and organize themselves to is called the basement membrane.
b) Bowman’s membrane
The next layer behind the basement membrane of the epithelium is a transparent film
of tissue called Bowman’s layer, composed of protein fibers called collagen. If
injured, Bowman’s layer can form a scar as it heals. If these scars are large and
centrally located, they may cause vision loss.
c) Stroma
Behind Bowman’s layer is the stroma, which is the thickest layer of the cornea. It is
composed primarily of water and collagen. Collagen gives the cornea its strength,
elasticity, and form. The unique shape, arrangement, and spacing of collagen proteins
are essential in producing the cornea’s light-conducting transparency.
d) Descemet's Membrane
Behind the stroma is Descemet’s membrane, a thin but strong film of tissue that
serves as a protective barrier against infection and injuries. Descemet’s membrane is
composed of collagen fibers that are different from those of the stroma, and are made
by cells in the endothelial layer of the cornea (see above). Descemet’s membrane
repairs itself easily after injury.
e) Endothelium
The endothelium is the thin, innermost layer of the cornea. Endothelial cells are
important in keeping the cornea clear. Normally, fluid leaks slowly from inside the
eye into the stroma. The endothelium’s primary task is to pump this excess fluid out
of the stroma. Without this pumping action, the stroma would swell with water and
become thick and opaque.
In a healthy eye, a perfect balance is maintained between the fluid moving into
the cornea and the fluid pumping out of the cornea. Unlike the cells in Descemet’s
membrane, endothelial cells that have been destroyed by disease or trauma are not
repaired or replaced by the body.

5
Physiology
Every time we blink, tears are distributed across the cornea to keep the eye
moist, help wounds heal, and protect against infection. Tears form in three layers:
 An outer, oily (lipid) layer that keeps tears from evaporating too quickly and
helps tears remain on the eye;
 A middle (aqueous) layer that nourishes the cornea and the conjunctiva – the
mucous membrane that covers the front of the eye and the inside of
the eyelids;
 A bottom (mucin) layer that helps spread the aqueous layer across the eye to
ensure that the eye remains wet.

The cornea acts as a barrier against dirt, germs, and other particles that can harm the
eye. The cornea shares this protective task with the eyelids and eye sockets, tears, and
the sclera (white part of the eye). The cornea also plays a key role in vision by helping
focus the light that comes into the eye. The cornea is responsible for 65-75 percent of
the eye’s total focusing power.
The cornea and lens of the eye are built to focus light on the retina, which is the light-
sensitive tissue at the back of the eye. When light strikes the cornea, it bends—or
refracts—the incoming light onto the lens. The lens refocuses that light onto the
retina, which starts the translation of light into vision. The retina converts light into
electrical impulses that travel through the optic nerve to the brain, which interprets
them as images.
The refractive process the eye uses is similar to the way a camera takes a picture. The
cornea and lens in the eye act as the camera lens. The retina is like the film (in older
cameras), or the image sensor (in digital cameras). If the image is not focused
properly, the retina makes a blurry image.

6
The cornea also serves as a filter that screens out damaging ultraviolet (UV) light
from the sun. Without this protection, the lens and the retina would be exposed to
injury from UV rays.
Innervation
The cornea is one of the most sensitive tissues of the body, as it is densely innervated
with sensory nerve fibres via the ophthalmic division of the trigeminal nerve by way
of 70–80 long ciliary nerves. Research suggests the density of pain receptors in the
cornea is 300-600 times greater than skin and 20-40 times greater than dental
pulp, making any injury to the structure excruciatingly painful.
The ciliary nerves run under the endothelium and exit the eye through holes in the
sclera apart from the optic nerve (which transmits only optic signals). The nerves
enter the cornea via three levels; scleral, episcleral and conjunctival. Most of the
bundles give rise by subdivision to a network in the stroma, from which fibres supply
the different regions. The three networks are, midstromal, subepithelial/sub-basal,
and epithelial. The receptive fields of each nerve ending are very large, and may
overlap.
Corneal nerves of the subepithelial layer terminate near the superficial epithelial layer
of the cornea in a logarithmic spiral pattern. The density of epithelial nerves decreases
with age, especially after the seventh decade.

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 CHAPTER III
Small Incision Lenticule Extraction (SMILE)

A. Definition

The SMILE procedure involves the use of the femtosecond laser to create an
intra-stromal lenticule that is then man-ually extracted through a small peripheral
incision.2 Early reports suggest that the safety and efficacy of the procedure is simi-
lar to LASIK in comparable cohorts and in-deed may offer increased benefits for
some patients.
The SMILE procedure reflects the progres-sion of several existing refractive
surgical techniques. Barraquer first developed the concept that refractive error may be
corrected by the removal of corneal tissue.
In the original keratomileusis procedure for myopia, an approximately 300 mm
thick disc was dissected from the anterior cornea in a freehand fashion and reshaped
using a cryolathe. In the late 1980s Ruiz developed an automated microkeratome that
controlled speed as it passed across the cornea, leading to more consistent results.
This procedure has become known as automated lamellar keratoplasty (ALK). In the
1990s the combination of a microkeratome and an excimer laser (for the refractive
cut) was developed by Pallikaris, Burato and others, further improving the
predictability of the refractive procedure. This procedure, known as laser assisted in
situ keratomileusis (LASIK) has gained wide acceptance word wide. The limitations
of this procedure have been already proven in long term 6 and 10 year follow-up
studies related to the induction of aberrations and regression. Recently, femtosecond
lasers have become available for the cutting of the intrastromal lenticule and
subsequent lenticule extraction. In the femtosecond-only technique for correction of
refractive errors (femtosecond lenticule extraction), the intrastromal lenticule is
removed using flap-like access. In small-incision lenticule extraction (SMILE), the
incision is minimized and the procedure does not use a flap. Both types of procedures
seem safe and promising for corneal refractive correction of myopia, although small-
incision lenticule extraction is not yet widely performed.

B. Inclusion and exclusion criteria of SMILE

Inclusion criteria were: myopia < 8 diopters (D), astigmatism < 2 D and < 20/30
BSCVA with glasses or contact lenses; contact lens intolerance; regular cornea
without ectasia as assessed by Orbscan corneal topography, IOP within normal limits
(with or without hypotensive drops); absence of retinal disease; and a minimum
follow-up period of three months.
Exclusion criteria were: corneal ectasia or keratoconus suspect, central corneal
thickness < 500 µm, history of recurrent uveitis, pigmentary glaucoma, cataract,
proliferative diabetic retinopathy, and macular pathology.

8
C. Surgical Procedure

Patients were administered a mild oral anxiolytic and sedative (diazepam,

Valium® 5 mg; Roche Farma S.A. Barcelona, Spain) 30 minutes before surgery.
Topical anaesthesia was given (oxibuprocaine hydrochloride 0.4%, Prescain®;
Laboratorios Llorens S.A., Barcelona, Spain) and after a povidone–iodine
(Betadine®) scrub of the skin and eyelids, the patients were draped with a sterile head
towel, their eyelashes were taped with sterile tape and they were positioned on the
ergonomic pivoting patient table of the laser unit.

The SMILE femtosecond procedure was initiated with the application of an

eyelid speculum to keep the eye open; the patient’s eye was positioned under a curved
contact glass interface. A completely clean and diffusely wet cornea was ensured
using a wet microsponge. This contact glass is similar to a gonioscopic lens in that it
possesses a curved surface designed to couple with the cornea with only minimal
applanation force. Before coupling, the VisuMax® femtosecond laser system (Carl
Zeiss Meditec AG, Jena, Germany) calibrates the contact glass. The eye’s keratometry
data is entered into the VisuMax® to account for the difference between the relaxed
cornea and the contact glass curvature.

The first femtosecond laser used was version 2.7.3 with maximum spot spacing
of 3.0 µm.

A fully device-integrated suction system ensures that low suction is only applied
to the cornea during the actual laser treatment. Centration is assisted using several
features including an internal fixation target for the patient which is designed to attract
their attention, self-adjustment of the eye during docking to the contact glass, an easy
to find line of sight for treatment positioning, and automated adaptation to patient eye
refraction. Flap parameters that can be adjusted include flap thickness, flap diameter,
hinge width, side-cut angle and hinge location.

Using this procedure, once contact is made between cornea and the contact glass,
the patient is able to see the flashing fixation target in clear focus. The patient’s
cooperation is fundamental for properly aligned treatment. When full contact glass
application is achieved, suction is applied, the eye immobilized, and the laser
activated by the surgeon by pressing on a foot pedal. A very accurately focused laser
beam is guided through to the cornea, whereby the laser beam moves across and
through the cornea in a spiral manner, creating a layer of very tiny bubbles under its
path. These bubbles quickly disappear, and the tissue above the bubbles becomes a
corneal lenticule that can be easily lifted by the surgeon.

In the SMILE procedure, instead of making a complete flap side cut, only a small
incision is created, and the flap is never lifted. Instead, the lenticule is extracted from
within the cornea through a small incision.

9
 In these cases, the duration of the entire procedure was relatively consistent, from
50 to 55 seconds, regardless of the refractive error to be corrected. This is an
advantage in terms of postoperative assessment of results among different correction
groups. The shape of the lenticule generated was designed to correct for refractive
errors. In all cases in this particular preliminary study group, the anterior surface of
the lenticule was 100 μm deep and the maximum diameter of the first cleavage plane,
6.0 mm. For technical reasons, astigmatism corrections result in an oval posterior
surface of the lenticule.

For all myopic corrections, the optical zone size was 6.0 mm. The spot-and-track
spacing for the cleavage plane, which defines the posterior surface of the lenticule,
was slightly higher than the spot-and-track spacing for the cleavage plane, which
defines the anterior surface of the lenticule (i.e. the cap). The posterior part of the
lenticule was created by laser scanning in spirals from the centre of the pupil to the
periphery of the optical zone. The anterior part of the lenticule was created by laser
scanning in spirals from the periphery to the centre of the pupil. All passes and spot-
and-track distance changes were automatically performed by the laser software and
hardware with no user intervention (Figure 1).

Figure 1. Intra-operative compilation of SMILE surgical procedure. Top left; Showing the
docking and laser ablation. Topright: Immediately following the laser ablation. The spatula
enters through the sidecut. Bottom left:The spatula is moved across the anterior and then
posterior lenticule surface. Bottom right: The lenticule is removed.

D. Contraindications

As discussed previously, the majority of contraindications for laser refractive

surgery remain similar for prospective SMILE patients; however, there remain several
points of difference (Table 1). The relative contraindications for SMILE are discussed
in further detail below.

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 1. Dry eye

The SMILE procedure has been shown to have a less pronounced impact up on
the ocular surface and corneal innervation compared with LASIK. Although Denoyer
et al demonstrated a high incidence of mild to moderate dry eye in comparative
LASIK and SMILE cohorts, the incidence was significantly higher in the LASIK
group at one month, an effect continuing through six months. Corneal sensitivity
similarly remained statistically better in the SMILE group. Nerve fibre density, as
measured with confocal microscopy was also better in SMILE patients. These results
are replicated in further studies and provide consistent evidence that both the corneal
flap and subsequent excimer laser ablation are significant contributing factors to dry
eye in laser refractive surgery patients. Against this several studies have failed to
show a statistical difference across dry eye parameters, such as tear film osmolarity,
tear break-up time or Schirmer’s tests. Moderate to severe dry eye remains a
contraindication to SMILE surgery with patients at risk of poor visual and safety
outcomes; however, patients with mild dry eye or those at increased risk of post-
operative dry eye symptoms may present as more appropriate candidates for SMILE
surgery compared to LASIK. Employing established therapies such as non-preserved
artificial tear or nutritional supplements will further increase post-operative patient
satisfaction.

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 2. Suspect keratoconus

Suspect keratoconus suggests a mild corneal irregularity that may not have
presented clinically in terms of reduced visual acuity or biomicroscopic signs. A
number of tomographic units serve to display the parameters of keratoconus that help
to objectively diagnose these cases. Despite these programs, there remains no clear,
reproducible set of parameters that enables the practitioner to confirm suspect or
forme fruste keratoconus. These patients remain at risk for progression following
kerato refractive surgery and therefore, they represent a significant concern for
treating specialists. The proposed retention of biomechanical strength following
SMILE may suggest the risk of corneal ectasia following surgery, particularly in
subtle cases of irregularity, will be reduced. Due to the current lack of long-term
available data, this remains as trictly the oretical proposal. Wang et al recently
describe a 19year-old patient with suspect keratoconus, who showed evidence of
ectatic progression at six months following the SMILE procedure. The patient age,
lack of refractive stability and irregular tomography suggest the presence of a number
of surgical contraindications, which have undoubtedly contributed to the post-
operative complication in this case and confirm the need for preoperative vigilance.
Ivarsen, Asp and Hjortdal2 did not report ectasia cases in their cohort of 1,500
patients after 12 months. Similarly, we have not seen any cases at our clinic
suggesting that vigilance at the screening visit will help minimize the risk of ectasia
following surgery. Further long-term follow-up will serve to confirm the relative
incidence as well as to better define the potential for patients with subtle corneal
irregularities to safely undergo the SMILE procedure.

3. Corneal scarring

Corneal scarring may represent a physical barrier to visual acuity, depending

on the origin, significant and location of the s carring; however, it may not
necessarily preclude patient from undergoing laser refractive surgery. Surface ablation
can represent the most appropriate option, if the scarring is superficial in nature.
LASIK has been used in cases with deeper or more pronounced scarring with
femtosecond laser energy parameters manipulated to ensure the cornea scarring does
not interfere intra-operatively; however, this may represent a more significant issue
with SMILE patients. To maximise efficiency in terms of refractive accuracy and the
recovery process, SMILE laser parameters have been progressively reduced.37
Currently, SMILE parameters are represented in nanojoules rather than microjoules as
required for LASIK flapcreation. This effectively reduces the ability of the laser to
pass through existing scar tissue therefore, reducing the ability to treat even mild
cases of scarring with this technique. The suitability for the SMILE surgery will
represent an individual decision undertaken at the consultation.

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E. Complications

a) Intra-operative complications

Early evidence suggests that the SMILE procedure is safe. Intra-operative

complications may occur; however, these are not likely to be sight threatening.
Suction loss can occur albeit the literature suggests an incidence of between 0.9 to 4.4
per cent of patients. If suction loss occurs prior to the laser ablation, the patient can be
re-engaged and the procedure can continue immediately. If suction is lost once the
laser has begun, the post-operative course will be determined by the amount of laser
completed. Early suction loss may represent an opportunity to re-engage and complete
without complication, whereas suction loss at the middle of the surgery may require
the procedure to be aborted in favour of later surface ablation. Epithelial disturbances
may occur due to the docking procedure or by the manual removal of the lenticule
through the laser created channel. A bandage contact lens is rarely required in our
experience; however, it may aid the post-operative comfort and healing process for
some patients. The difficulty of extracting the lenticule may vary depending on the
laser energy settings. This is usually resolved quickly following installation. It is
possible that the lenticule may be partially torn during the procedure. Further attempts
to remove the remaining lenticule should be undertaken. Dong and Zhou reported a
case of irregular astigmatism following the SMILE procedure, possibly related to
incomplete dissection and subsequent residual lenticule left within the pocket.

b) Post-operative complications

The absence of a corneal flap, as in the LASIK procedure, removes the risk of related
concerns such as flap displacement or striae. Otherwise, the SMILE procedure
maintains a similar risk profile following surgery with alternate laser refractive
procedures. Reported post-operative complications include; epithelial ingrowth,
diffuse lamellar keratitis, corneal haze, irregular astigmatism, increased aberrations,
ectasia, punctate corneal staining and mild dry eye

1. EPITHELIAL INGROWTH

Ingrowth may be caused by epithelial cells displaced at the time of the

procedure or through cells invading the SMILE incision site. As per LASIK surgery,
not reatment is often required for mild cases. The risk for the progression of irregular
astigmatism or corneal melt increases significantly, if the ingrowth is considered
severe. Surgical intervention is warranted in these cases. The risk of epithelial
ingrowth in LASIK procedures has been estimated to range from 0.01to
6.1percent.The relative potential risk for ingrowth in SMILE cases should be less as
the entry point for epithelial cells is negligible compared to the full LASIK flap.
Furthermore, minimal washout is typically required, there by diminishing the risko f
cells or debris being introduced. A recent review of existing literature on the safety
and efficacy of SMILE revealed an accumulative risk of epithelial ingrowth of 0.5 per

13
cent.37 Ivarsen, Asp and Hjortdal2 describe10eyes (outof1,500) with islands of
epithelial cells seen near the incision site. No progression was seen over three months
and in 5 cases the cells spontaneously disappeared by one year. Our current
experience reflects this with only one case requiring secondary treatment. The patient
was returned to surgery and the cells removed. Visual acuity was 6/6 at day 1 with no
pain or photophobic symptoms.

2. DIFFUSE LAMELLAR KERATITIS

Diffuse lamellar keratitis (DLK) was first described in 1998 in conjunction

with the LASIK procedure. Representing an acute inflammatory response, the patient
usually presents with increasing discomfort, photophobia and a reduction in visual
acuity. Biomicroscopic signs have been described,50 briefly small white, granular
cells may be seen under slitlamp investigation increasing with the severity of the
condition. Severe cases may lead to stromal necrosis without furthert reatment.
Typically, cases present during the immediate post-operative period. A definitive
cause of diffuse lamellar keratitis remains unclear; however, the condition has
variously been attributed to the introduction no f bacteria, surgical debris, meibomian
gland secretions and immune infiltrates. The existence of epithelial defects has been
shown to significantly increase the risk of diffuse lamellar keratitis. The incidence of
diffuse lamellar keratitis following SMILE has been reported as between 0.04 and1.6
percent. Of particular interest, Zhaoetal 50 found that diffuse lamellar keratitis was
associated with larger lenticule diameter and thinner lenticules. The authors proposed
that gas bubble accumulation in cases of thin lenticules may induce a greater
inflammatory response given the anterior and posterior poles may accordingly be
under more significant compressive force
Alternatively the thin nerlenticules may represent a greater technical challenge
increasing the intra-operative manipulation and the reby possible inflammatory
response. Zhao et al 50 suggest that the proximity to the limbus and limbal
vasculature of the larger diameter lenticules may further give rise to inflammatory
cells. Further studies are required to elucidate the causes. It should be noted that all
cases resolved without sequellae following treatment with topical corticosteroids.

3. CORNEAL HAZE AND OEDEMA

Up to eight per cent of patients in a study by Ivarsen, Asp and Hjortdal were found
to have trace haze at the initial post-operative visit. This did not impact upon visual
acuity and subsequently subsided. Yao et al describe micro-distortions in Bowman’s
layer of up to 88.5 per cent of SMILE cases. This was in comparison to only 42.1 per
cent per cent of LASIK comparable cases. These micro-distortions were diagnosed
through optical coherence tomography (OCT). There was no additional evidence of
corneal striae under biomicroscopy and the micro-distortions appeared to stabilise at 1
week suggesting minimal impact upon visual acuity or quality. Similarly Moshifar et
al37 reported only 0.2 per cent of patients in the combined review with mild corneal

14
oedema. In summary, corneal distortion does not appear to represent a significant
clinical issue in SMILE patients. Miao et al 52 describe the optical quality and
intraocular scattering after the SMILE procedure. The authors found that SMILE had
little impact upon the retinal image and further that the objective scatter index quickly
returned to normal following a temporary increase at three weeks. As corneal haze
and anterior keratocyte loss have been indicated as the main cause of a decrease in
both parameters following excimer laser procedures, these results would appear to
confirm the lack of corneal distortion in SMILE patients. Riau et al describe a
statistically significant increase in inflammatory cells in patients undergoing LASIK
as compared to lenticule extraction. All patients observed had moderate to high
myopia (-6.00 to -9.00 D) suggesting a possible further benefit for the SMILE
procedure in reducing the incidence of corneal inflammation post-surgery.

4. IRREGULAR ASTIGMATISM AND INCREASED HIGHER-ORDER

ABERRATIONS

Irregular astigmatism may result in ghost images or loss of visual acuity.

Ivarsen, Asp andHjortdal2 describe six eyes of five patients with monocular ghosting
following surgery. In all cases, corneal to pography showed irregular astigmatism.
Interestingly, only one eye could be directly attributed to a peri-operative
complication (suction loss and attempted re-treatment). All cases showed irregular
Bowman’s layer with compensatory epithelial hyperplasia on OCT.48 Due to the
epithelial hyperplasia, topography-guided surface ablation was undertaken in these
patients with a reduction in visual complaints and subsequent improvement in visual
acuity in most cases. Two eyes developed grade 2 corneal haze following surface
treatment resulting in worsening of symptoms. Both cases did not use mitomycin C
during surgery suggesting this may be beneficial in these cases. Li et al54 describe
decentration following the SMILE procedure in a cohort of 100 patients. The mean
decentred displacement was 0.17 ± 0.09 mm. Although 99 per cent of patients had
post-operative uncorrected visionof6/6orbetter, fifteen eyes lost one line of visual
acuity and two eyes lost two lines at the final post-operative visit. Vertical coma
showed the greatest increase in magnitude possibly contributing to the decrease in
visual acuity.

5. ECTASIA

Ectasia remains a significant concern for refractive surgeons. As discussed

previously, one of the proposed benefits of SMILE over LASIK in particular is the
minimisation of biomechanical changes following surgery. This would suggest a
reduction in the risk fore ctatic changes following the surgical l procedure. Through
mid-2015, only one case of ectasia related to a SMILE procedure has been reported in
the peer-reviewed literature. In this case report, the patient appeared to have pre-
existing keratoconus.36 Although this is like ly to correspond with the proposed
biomechanical benefits of SMILE, it is likely also a consideration of our greater

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understanding of potential risk factors for ectasia. Longer term data, with
corresponding data sets, will provide confirmation of the potential benefits of SMILE
over LASIK surgery in particular.

6. INFECTIOUS KERATITIS

Infectious keratitis remains a potentially devastating complication of corneal

refractive surgery. Fortunately, the incidence is rare with published rates as low as
0.011 per cent in LASIK cases and 0.066 per cent following surface ablation. Patients
may complain of significant loss of vision accompanied by pain, photophobia and
epiphora. The condition usually presents in the early post-operative period and may
appear similar to diffuse lamellar keratitis or epithelial ingrowth. Biomicroscopic
signs should distinguish keratitis from these conditions. Initial treatment is with
broad-spectrum antibiotics and amended depending on the resolution of signs.
Ivarsen, Asp and Hjortdal2 noted five eyes with interface infiltrates and ocular
irritation following SMILE (0.33 per cent). Samples were taken for microbiological
investigation how ever no specific antigens could be identified. Patients were treated
topically in four cases with the further case requiring the interface to be flushed with
cefuroxime. All eyes cleared without sequellae by three months. There are no further
reports in the current literature.

7. DRY EYE

The majority of literature relates the presence of significant dry eye symptoms
with the transection of corneal nerves during surgery. This may lead to the
suppression of tear secretion from the lacrima lgl and, mucin expression on the
corneal epithelium and blink rate changes, which impact upon the corneal surface.
Further risk factors for post-surgery dry eye, include pre-existing dry eye disease,
deeper laser ablations, LASIK flap size, thickness and position albeit evidence
remains variable. As described earlier, results suggest that SMILE patients recover
more quickly and have less significant symptoms than patients undergoing the LASIK
procedure. These findings have clinical significance. Li et al30 describe significantly
less corneal fluorescein staining on slit lamp investigation; however, no significant
differences in Schirmer test results were found between corresponding SMILE and
LASIK groups. Subjective patient satisfaction remains increased in SMILE patients in
comparison to LASIK groups. An ecdotally, this is what we have experienced in our
clinical practice, namely, despite the longer visual recovery of SMILE patients
compared to LASIK, the patients themselves report being more comfortable and
happier during the post-operative recovery period.

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 CHAPTER IV
DISCUSSIONS

SMILE is a fairly new procedure of corneal refractive surgery. Recent

publications, including up to 150 patients, suggest that this femtosecond laser flap-
free refractive procedure demonstrates predictability, safety, and efficacy similar to
that of femtosecond laser–assisted LASIK. Another study involved treatment of
moderate and high myopia in 670 eyes confirmed that SMILE is predictable,
effective, and safe.
SMILE provides good outcomes in terms of refraction as well as additional
benefits, such as a reduction in scatter that leads to better vision quality. Despite the
proven efficacy of LASIK, it still requires the use of two machines: one for the flap
creation and another for Excimer ablation. is increases costs as well as the surgical
time for the procedure. SMILE uses only one laser machine, thus potentially reducing
surgical time and cost. Moreover, SMILE does not involve any flap creation, which
potentially reduces risk of side effects such as dry eyes and other flap related
complications.

SMILE procedures eliminates flap displacement, and there is no risk of the

flap dislocating with trauma to the eye at a later point. Additional benefits may
include postoperative reduction or elimination of dry eye problems and improvements
in corneal biomechanical stability.

In the near future, we foresee that SMILE may develop into a reversible
surgical procedure. Unlike LASIK which uses an excimer laser to ablate corneal
tissue, SMILE cuts and removes a piece of corneal lenticule, which may be stored and
replaced into the cornea later on. This is important as we can potentially reverse the
refractive procedure many years later when the patient’s myopia decreases. The
ability to re-implant the cornea lenticule allows for treatment of corneal ectasia,
reversal or monovision, or even the possibility of use as a presbyopic implant.

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 REFERENCES
1. Blum   M,   Kunert   K,   Schroder   M,   Sekundo   W.   Femtosecond   lenticule
extraction for the correction of myopia: preliminary 6­month results. Graefes
Arch Clin Exp Ophthalmol. 2010; 248:1019–27. 

2. Paula Verdaguer, MD; Mostafa A. El-Husseiny, MD, et al. Small incision

lenticule extraction (SMILE) procedure for the correction of myopia and
myopic astigmatism, 2013; 4: 191 - 196

3. Sekundo W, Kunert K, Russmann C, et al. First efficacy and safety study of

femtosecond lenticule extraction for the correction of myopia: six-month
results. J Cataract Refract Surg. 2008; 34:1513–20; erratum, 1819

4. Vestergaard A, Ivarsen A, Asp S, Hjortdal J. Femtosecond (FS) laser vision
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ReLEx   ex,   and   comparison   with   a   retrospective   study   of   FS­laser   in   situ
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