Scientific Foundation SPIROSKI, Skopje, Republic of Macedonia

Open Access Macedonian Journal of Medical Sciences. 2022 Feb 03; 10(B):668-673.
https://doi.org/10.3889/oamjms.2022.8040
eISSN: 1857-9655
Category: B - Clinical Sciences
Section: Ophthalmology

Femtosecond Small Incision Lenticular Extraction in comparison

to Femtosecond Laser In situ Keratomileusis Regarding Dry Eye
Disease
Najah Kadhum Mohammad1 , Suzan Rattan2 , Ahmed Shaker Ali Al Wassiti1, Zaid Al-Attar3*
1
Department of Surgery and Ophthalmology, Baghdad College of Medicine, University of Baghdad, Baghdad, Iraq; 2Department
of Surgery, Al-Kindy College of Medicine, University of Baghdad, Baghdad, Iraq; 3Department of Pharmacology, Al-Kindy
College of Medicine, University of Baghdad, Baghdad, Iraq

Abstract
Edited by: Ksenija Bogoeva-Kostovska BACKGROUND: The objective was comparison of femtosecond small incision lenticule extraction (FS-SMILE)
Citation: Mohammad NK, Rattan S, Al Wassiti ASA,
Al-Attar Z. Femtosecond Small Incision Lenticular
versus Femtosecond laser in situ keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity
Extraction in comparison to Femtosecond Laser In situ (CS) after these refractive surgeries.
Keratomileusis Regarding Dry Eye Disease. Open Access
Maced J Med Sci. 2022 Feb 03ja AIM:  The difference between FS-SMILE and FS-LASIK regarding dry eye symptoms, signs, and corneal sensitivity
; 10(B):668-673. https://doi.org/10.3889/oamjms.2022.8040
Keywords: Dry eye; Corneal sensitivity; Small incision
post-refractive surgeries in two groups of matched patients.
lenticule extraction; Femtosecond laser-assisted laser;
In situ keratomileusis; Refractive surgery METHODS: A comparative prospective study was conducted for a period of 2 years, from March 2017 to February
*Correspondence: Zaid Al-Attar, Department of 2019. Enrolled patients were diagnosed with myopia. Fifty patients (100 eyes) were scheduled for bilateral FS-SMILE
Pharmacology, Al-Kindy College of Medicine, University
of Baghdad, Baghdad, Iraq. E-mail: zaidattar@kmc. and the other 50 patients (100 eyes) were scheduled for bilateral FS-LASIK. Both groups were followed for 6 months
uobaghdad.edu.iq after surgery. The age, gender, and pre-operative refraction for both groups were matched. Complete evaluation of
Received: 22-Nov-2021
Revised: 20-Jan-2022
dry eye disease had been performed at regular intervals. The evaluation included history of symptoms according to
Accepted: 24-Jan-2022 scoring systems, investigations, and clinical examination.
Copyright: © 2022 Najah Kadhum Mohammad,
Suzan Rattan, Ahmed Shaker Ali Al Wassiti, Zaid Al-Attar RESULTS: One month postoperatively and in both groups, there was significant DED (p <.01), although incidence
Funding: This research did not receive any financial
support was lower in femtosecond SMILE group, overall severity score (0–4): 0.3 ± 0.3 (FS-SMILE) versus 1.4 ± 0.9
Competing Interests: The authors have declared that no (LASIK). One month postoperatively, CS was lower in FS-LASIK more than FS-SMILE eyes (2.3 ± 2.2 vs. 3.6 ± 1.8,
competing interests exist
Open Access: This is an open-access article distributed
respectively, p <.01) and then shifted to non-statistically significant sensitivities at 6-month duration. DED was
under the terms of the Creative Commons Attribution- negatively correlated with CS (p < 0.01).
NonCommercial 4.0 International License (CC BY-NC 4.0)
CONCLUSIONS: The FS-LASIK surgery had a more pronounced effect on CS and DED compared with FS-SMILE,
with higher incidence of DED post-refractive surgery.

Introduction during creating the flap, in addition to damage by the

excimer laser photo ablation [5]. The vast majority of
factors reported to be involved in the pathogenesis
Recently, introduced femtosecond small- of DED, such as tear secretion, quality of tear-film,
incision lenticule extraction (FS-SMILE) is a procedure healing of the epithelium of the cornea, and the rate
that gathered numerous benefits, like FS laser of blinking, all could be affected post-refractive LASIK
that is used for fashioning a corneal intrastromal procedures  [6]. The SMILE operation constitutes a
lenticule that is removed manually through a small minimally invasive refractive surgery for the cornea,
(2–7  mm length) peripheral corneal incision [1], [2]. because it merely requires a small tunnel, with less
This relatively new technique does not require a associated damage to corneal nerves, thus further
flap, which, in turn, reduces some flap related side protection for patients against DED [7]. Clinical studies
effects of FS-LASIK, such as dislocation and related had reported refractive results, CS, and clinical ocular
astigmatism [2], [3]. Dry eye continues to be the most surface dryness post SMILE surgeries, but nothing
frequent adverse effect after LASIK. Mild to severe else has been done to estimate the overall severity
ocular surface dryness symptoms are experienced of the dryness, which demands integrating objective
by many patients, after LASIK, that are adequately tests along with symptoms reported subjectively by
controlled using artificial tears. If symptoms keep to patients, as recommended by Delphi [7]. The current
be reported for long duration, 20–40% of patients study aimed to investigate the difference between
may develop chronic dry eye disease (DED) 6 months FS-SMILE and FS-LASIK regarding dry eye symptoms,
postoperatively [4]. Proposed factors that cause signs, and corneal sensitivity post-refractive surgeries
DED post LASIK include corneal nerves disruption in two groups of matched patients.

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 Mohammad et al. SMILE e
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Material and Method Ethical considerations

After the approval of Ethical Committee of
Al-Istishari Hospital, informed written consent was
Study design and setting
gained from each participant, which included adequate
A comparative prospective interventional information regarding the aim and methods of the
study conducted at the Refractive Surgery Center current study.
of Al Istishari Hospital, Baghdad, Iraq for a period of
20 months from March 1, 2017, to October 31, 2018.
Materials
Anterior segment spectral-domain OCT was
Study population
done by (Canon, HS 100, TOKYO, JAPAN), Corneal
The included patients had bilateral eyes with esthesiometry, slit lamp, Fluorescein paper, and
spherical correction range from −2 to −6 diopters and Whitnall paper.
cylinder range from 0 to – 3.5 diopters and seeking for
management and willing to participate in this study.

Exclusion criteria
Method/Evaluation of Dry Eye Disease
Patients presented with sign or symptom of dry
eye disease (tear film breakup time (TBUT) >10 s, Schirmer Clinical examination
I test >10  mm/5  min), corneal or conjunctival staining,
All the examinations were performed 1  week
Meibomian gland dysfunction, previous ocular and or
preoperatively, 1 and 6  months after the surgery.
eye lid medical or surgical treatment, and pregnancy and
The post-operative clinical examination was done by
chronic systemic disorder were excluded from the study.
another ophthalmologist, who was masked to type of
performed procedure and administered the OSDI for
Sample size all patients for assessing the exact impact of DED on
vision and related quality of life [9]. DEWS severity was
The sample size was calculated according the evaluated according to an overall index (from 0 to 4)
two proportions formula: and including symptoms and signs [1], [10].
(Zα / 2 + Zβ)2* (pSMILE(1 − pSMILE) Corneal esthesiometry was performed 1 and
+pLASIK(1 − pLASIK)) 6 months postoperatively. The sensitivity of the cornea
N= = 80.38 was measured using contact nylon thread [Cochet,
(pSMILE − pLASIK)2
Bonnet esthesiometer]. Measurements were taken and
where Zα/2 equals 1.96 for confidence level of data reported as the mean of three measurements at
95%, Zβ equals 1.28 for a power of 90%, and pSMILE and the center of the cornea.
pLASIK were the expected prevalence of dry eye after
6 months in corresponding groups and were reported by
Denoyer et al. (2015) to be 20% and 43% [8], respectively. Investigations
The estimated sample size was increased to 100 eyes 1. Anterior segment OCT was done 6  months
in each group to avoid dropouts and increase study after the date of surgery. Two images of each
power. Patients were assigned into two age, gender, and cornea were acquired with apex measurement
spherical equivalent matched equal groups: of corneal thickness, epithelial thickness, and
• FS-SMILE Group: 100 eyes of 50 patients who the interface depth.
underwent bilateral FS-SMILE. 2. Slit-lamp examinations were conducted in
• FS-LASIK Group: 100 eyes of 50  patients a defined sequence [11] and included three
underwent bilateral FS-LASIK. TBUT measurements and their calculated
mean, and the Oxford score which incorporated
fluorescein staining and graded from 0 to 5.
Study outcomes 3. ST-1 in mm per 5  min, without topical
anesthesia.
All patients participated in this study attended
the follow-up periods of 1 and 6  months post-
refractive surgery. Outcomes were assessed using
Surgical technique
Ocular Surface Disease Index (OSDI) (0-100), Tear
Break-Up Time (TBUT) (in seconds), Schirmer I test All surgeries were performed by single
(ST-1) (in mm/5 min), Oxford score (0-5), and Dry Eye experienced surgeon under topical anesthesia
Workshop (DEWS) scale (0-4). [Tetracaine eye drop 0.5%] using the following technique:

Open Access Maced J Med Sci. 2022 Feb 03; 10(B):668-673. 669
B - Clinical Sciences  Ophthalmology

• For FS-LASIK group, superior-hinge flap Table 1: Comparison between study groups by patient features,
with 120  µm thickness, 8.0  mm diameter, visual outcomes, and corneal morphology
and 45° side cut angles were created with Variable FS‑SMILE Group FS‑LASIK Group p
(n = 50) (n = 50)
500  kHz VisuMax femtosecond laser, 160 nJ Pre‑operative
energy [Carl Zeiss, Meditec, Germany]. The Age (Years) 27.3 ± 5.2 28.2 ± 6.4 0.442
Gender (M/F ratio) 0.52 0.56 0.688
spherocylindrical refractive corrections with Spherical equivalent (D) −4.54 ± 1.95 −4.35 ± 2.12 0.511
optical zone 6.5 mm and ablation zone 8.0 mm Six months outcomes
Spherical equivalent (D) −0.02 ± 0.4 0.03 ± 0.39 0.901
were done by excimer laser operating system Distant best uncorrected 0.07 ± 0.1 0.07 ± 0.1 1.0
visual acuity (log MAR)
[Carl Zeiss, Meditec, MEL 90, Germany]. Epithelial thickness (μm) 40.1 ± 12.2 39.9 ± 11.5 0.905
Automatic iris registration and pupil-tracking Total corneal thickness (μm) 490.6 ± 38.1 500.8 ± 39.1 0.062
Depth of the interface (μm) 118.4 ± 3.9 117.9 ± 4.8 0.419
system were activated before photoablation.
• For FS-SMILE group, 120  µm cap thickness;
7.6  mm cap diameter; and 6.5  mm lenticule were significantly lower in FS-SMILE group than that in
diameter were performed with 500 kHz VisuMax FS-LASIK group (8.2 vs. 19.6, p < 0.01; and 0.3 vs. 1.4,
femtosecond laser, 160 nJ energy [Carl Zeiss, p < 0.01, respectively), while TBUT was significantly
Meditec, Germany]. The patient was fixating higher in FS-SMILE group than that in FS-LASIK group
on light target during suction procedure to a (8.0 vs. 5.8, p < 0.01) (Table 2).
chief central lenticule. At the end, incision of Table 2: Dry eye disease 1 and 6 months after refractive surgery
3 mm in length was created at the 130° position One month postoperatively Six months postoperatively
for lenticule extraction. In both groups, 0.3% FS‑SMILE FS‑LASIK p FS‑SMILE FS‑LASIK p
Tobramycin and 0.1% with dexamethasone OSDI (0–100)
TBUT (s)
20.5 ± 13.1 23.7 ± 15.2
6.2 ± 1.3 5.8 ± 1.7
0.08
0.13
8.2 ± 3.9
8.0 ± 1.6
19.6 ± 5.5 <0.01
5.8 ± 1.6 <0.01
suspension (Tobradex, Alcon Laboratories) every ST‑1 (mm/5′) 15.3 ± 5.6 20.2 ± 8.7 0.06 18.2 ± 9.3 17.1 ± 8.1 0.85
Oxford score (0–5) 0.06 ± 0.32 0.29 ± 0.61 0.17 0 0.38 ± 0.5 0.06
6  h for 2  weeks with preservative-free sodium DEWS (0–4) 1.2 ± 0.7 1.7 ± 0.7 0.07 0.3 ± 0.3 1.4 ± 0.9 <0.01
hyaluronate were used 6 times/day for 30 days.
After 1-month post-operative, sodium hyaluronate The distribution of the severity of dry eye disease
with or without lubricant gels were administered in 1 and 6  months after SMILE versus LASIK is detailed
frequency and duration according to their need. in Table  3. One month after the surgery, there was not
statistically difference between the two groups p > 0.05.
Table 3: Distribution of post‑refractive dry eye disease 1 and 6
Statistical analysis months postoperatively

The data were handled using the Statistical DEWS One month postoperatively
SMILE (%) LASIK (%) p–
Six months postoperatively
SMILE (%) LASIK (%) p
Package for Social Sciences (SPSS) version 25. Data n = 100 n = 100 n = 100 n = 100
representation included mean, standard deviation, and Zero
One
40 (40.0)
44 (44.0)
36 (36.0)
30 (30.0)
>.05 80 (80.0)
16 (16.0)
38 (38.0)
24 (24.0)
<0.05

ranges. The frequencies and percentages presented by Two 12 (12.0) 24 (24.0) 4 (4.0) 22 (22.0)
Three 4 (4.0) 10 (10.0) 0 16 (16.0)
Categorical data. The comparison between the studded
groups done continuously with variables according to Six months postoperatively, quality of life
independent t-test (two tailed). A level of p < 0.05 was and tear film quality were significantly better in the
considered significant. FS-SMILE group compared with the FS-LASIK group.
Worse scores of DED were found in FS-LASIK group
p <05 (Tables 2 and 3). Seventy six percent of patients
in FS-SMILE group stopped using any eye drops at
Results 6 months postoperatively compared to 52% in FS-LASIK
group. No patients in FS-SMILE group needed any tear
substitutes 6  months after surgery versus 18% of the
This study enrolled a total of 200 eyes that FS-LASIK group who needed four times daily instillation
undergone refractive correction with no adverse effects of artificial tears even gels (Figure 1).
reported among them. No statistically significant
Frequency of using drops 6 months after surgery
differences were found between the two study groups
76%
regarding age, sex, spherical equivalent myopia, and Drops QID ± gel
morphologic parameters as total corneal thickness Drops TID 52%
(TCT), epithelial thickness, and the interface depth, as Occasional
shown in Table 1. No drops
20% 18% 16% 14%
4%
DED 1 and 6 months postoperatively 0

Preoperatively, there were no statistically FS-SMILE FS-LASIK

significant differences regarding DED between the two Figure 1: Tear eye drops used 6 months postoperatively in the two
study groups. After 6 months, OSDI and DEWS scale study groups

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 Mohammad et al. SMILE e
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Corneal sensitivity postoperatively suggest a stepwise recovery of the normal physiology

in both procedures. In LASIK, there was reduced nerve
Corneal sensitivity was reduced in both
density in the cornea over the long-term [17], [26], [27],
groups  1  month after the surgery, but FS-LASIK
while SMILE preserved the density as reported in the
eyes showed lower sensitivity than FS-SMILE eyes
previous studies [8], [28].
(p < 0.01). Six months postoperatively, there was no
statistical difference between the two groups, and both The post-operative corneal reinnervation is
returned to normal, p > 0.05 (Table 4). highly variable, and the duration ranges from 3 months
to 5 years according to different studies²⁹. Another factor
Table 4: Corneal sensitivity postoperatively as measured by the
Cochete‑Bonnet esthesiometer
in LASIK might be the pathological increment in tear
osmolarity, which seems not to occur in SMILE [29], [30],
Corneal sensitivity (cm) Study group P value
SMILE LASIK this might suggest that the post-operative dryness is
One month postoperatively 3.6 ± 1.8 2.3 ± 2.2 <0.01>0.05 usually a combination of neurogenic and inflammatory
Six months postoperatively 5.8 ± 0.2 5.6 ± 0.3
mechanisms [31].
Increased density of ocular surface dendritic
cells was found 6  months after Lasik, which further
support the role of inflammatory process in DED [8].
Discussion Tear cytokine measurement as inflammatory mediator
could be better way for analyzes these inflammatory
processes [31].
The present study was designed
comprehensively regarding the approach to DED Epithelial thickness assessment by OCT at
following the two refractive surgical modalities, the center of the cornea did not show any difference
demonstrating an increment in symptoms (OSDI score), between FS-SMILE and FS-LASIK groups  6  months
and signs (TBUT) 6  months postoperatively in both post-operative. In the present study, bilateral surgery
FS-SMILE and FS-LASIK groups. Thus, there were lower for each patient was performed using similar technique;
values on these scales in patients treated with FS-Lasik thus, it was possible to perform inter-individual
compared to FS-SMILE for 6  months postoperatively, comparisons. Patients undergone LASIK or SMILE,
as some authors have reported [12], [13], [14], although which were matched and paired by age, gender, and
ocular signs are often found to be highly variable, as refraction, this design might create a limitation compared
pointed out by Feng et al. [6] Using a self-reported with a paired-eye approach (one eye operated by
symptoms, questionnaire reported that 40% of the SMILE and their fellow eye operated by LASIK). Good
patients after LASIK believed that their eyes became understanding of the pathogenesis involved in ocular
dryer than before the surgery, Shah et al. [15] Recently, dryness after corneal photorefractive surgery is a vital
Li et al. [16] compared FS-Smile and FS-Lasik for ocular issue for two important reasons. First, to know the
surface dryness and reported a better TBUT and OSDI severity and impact of post-operative ocular dryness
in eyes treated with the former compared with eyes on quality of life and influenced the development of
treated with the latter, also reported that the patients novel refractive procedures such as SMILE. Second,
who had LASIK used eye drops more frequently for for determining the risk factors for post-operative DED
prolonged times, which might negatively affect the and further comprehending the indications for each
quality of life and the costs of these drops in this young refractive procedure.
population. In LASIK, flap creation and damage to sub-
basal nerves contributes as a main, but not exclusively
as a cause for ocular dryness. While, in SMILE Limitations of the study
procedures, more innervation in protected as it creates The present study reported significantly
only a 40°–60° – wide penetrating corneal tunnel, in lower CS in the FS-LASIK group in comparison to the
comparison to about 300° in LASIK. From the starting of FS-SMILE group at 1 month following the surgery but
refractive surgeries, studies had reported a significant not at 6 months, although some improvement to the
decrement in CS following LASIK, which probably lasts outcomes of the study could be done by optimizing
for months or even years, even if the flap was created how to assess CS, like, incorporating a non-contact
by femtosecond laser [17], [18], [19], [20], [21]. Recent esthesiometer, and by recording the blinking rate and
clinical studies reported that SMILE preserved CS in tear clearance, but the lack of appropriate equipment
comparison to LASIK [16], [22], [23], [24]. In the present made it not possible. Other limitations were small
study, CS significantly decreased compared to pre- sample size and the relatively short follow-up period
operative values at 1 month postoperatively after LASIK, of 6  months. The approach in the present study
which went back to normal at 6 months in both groups, may be regarded as a limitation since the paired
these were comparable to results of Demirok et al. [23]. eye approach may be more disguised method for
Labbé et al. [25] reported that after 6 months, the comparison, but it is not easily accepted by most
CS was not different compared to healthy controls that patients.

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