Original Article

Safety and efficacy of low‑energy small incision lenticule extraction for the
correction of myopia and myopic astigmatism: A retrospective analysis

N V Arulmozhi Varman, Aadithreya Varman, Dinesh Balakumar

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Purpose: To determine the safety and efficacy of low‑energy settings in small incision lenticule Access this article online
extraction (SMILE) for correcting myopia and myopic astigmatism. Methods: We included patients Website:
aged ≥18 years with the myopia of −0.5 to −10 D and myopic astigmatism of −0.5 to −5 Dcyl in this www.ijo.in
YQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8KKGKV0Ymy+78= on 08/31/2023

retrospective case series performed at a private eye hospital in South India. All patients had preoperative DOI:
best‑corrected visual acuity of LogMar 0.0 ± 0, with stable refraction for 1 year and normal corneal 10.4103/ijo.IJO_1757_22
topography. Ocular surface disease and other pathology cases were excluded. The repetition rate of the
laser was 500 kHz, and the pulse energy was 110 nJ. The lenticule diameter was set at 6.5 mm, cap diameter
was 7.20 mm, and intended cap thickness was 110–130 m. The spot distance was 4.5 µm. All patients were Quick Response Code:
evaluated immediately postoperation and on postoperative days 1, 8, and 30. Results: Overall, 541 eyes
were included. The mean patient age was 25.03 ± 4.1 years. The mean spherical error was -3.76 ± 1.84 Ds.
The mean cylinder was -1.24 ± 0.91. The mean spherical equivalent of refraction was −4.22 ±1.94 D. The
logMAR on postoperative day 1 was 0.0 ± 0. The mean spherical equivalent at 1 month was 0.28 ± 1.06 D.
There was no loss of Snellen’s lines after the procedure. The mean spherical equivalent of refraction to the
target was 95% within ± 0.50 D. The postoperative astigmatism was within 0.5 Dycl. No intraoperative
complications of SMILE including retained lenticule fragments, tears of incision, or improper dissection
occurred. Conclusion: Low‑energy settings in SMILE are safe and effective in correcting myopia and
myopic astigmatism including high cylinders (>3 Dcyl).

Key words: Femtosecond, LASIK, SMILE

Refractive correction procedures, intended to correct refractive
errors, have been in clinical application for decades. There
have been advances in corneal reshaping techniques, ranging
from the application of mechanical flattening procedures
such as radial keratotomy to the use of excimers and
femtosecond lasers, to achieve a safer and more predictable
outcome.[1‑3] Photorefractive keratectomy (PRK) and laser in situ
keratomileusis (LASIK) are undoubtedly proven to be effective
in the correction of myopia and myopic astigmatism.[4,5]
The existing techniques have certain shortcomings. Surface
ablation procedures such as PRK are associated with a delayed
recovery period, corneal haze, and regression of the refractive
error. These issues were largely eliminated with the advent
of LASIK. However, the major drawback with LASIK is the
occurrence of flap‑related complications and the occurrence
of post‑LASIK ectasia, albeit rare.[6,7] Small incision lenticule
extraction (SMILE) is the latest technique used for laser
refractive correction. In SMILE, high‑frequency energy pulses
of the femtosecond laser are delivered directly into the corneal
stroma without the need for flap creation. The intrastromal
lenticule is then dissected and extracted through a 2‑mm
incision.[8]
SMILE has significant advantages over its predecessors in
terms of smaller incision size, preservation of the biomechanical
strength of the cornea, minimum damage to the corneal
nerves for less frequent incidence of dry eyes, and absence of
flap‑related complications.[9‑11]
However, the major barrier to SMILE for being adopted
as a standard of care for the treatment of myopia and myopic
astigmatism is the lack of iris registration to compensate for
the cyclotorsion of the eye when the patient moves from the
standing to the supine position. This creates a controversy over
its efficacy in accurately correcting high cylinders (>3 Dcyl).
Recent studies have shown that SMILE can correct high
cylinders.[12,13] Currently, the US Food and Drug Administration
has given approval for the correction of myopia up to 10 D and
astigmatism up to 3 D. However, the role of cyclotorsional
compensation for the correction of cylinders is yet to be
established. The optimal energy settings to be used for a safe
completion of the procedure while providing early visual
recovery remain unclear.
Past studies on the visual outcomes of SMILE reported a
longer recovery time than that in femtosecond‑LASIK, which
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Uma Eye Clinic, Chennai, Tamil Nadu, India

For reprints contact: WKHLRPMedknow_reprints@wolterskluwer.com
Correspondence to: Dr. Aadithreya Varman, Uma Eye Clinic,
O Block, 2nd Avenue, Annanagar, Chennai 40, Tamil Nadu, India. Cite this article as: Varman NV, Varman A, Balakumar D. Safety and efficacy
E‑mail: aadithreyavarman@gmail.com of low‑energy small incision lenticule extraction for the correction of myopia
Received: 19-Jul-2022 Revision: 11-Oct-2022 and myopic astigmatism: A retrospective analysis. Indian J Ophthalmol
2023;71:476-80.
Accepted: 31-Oct-2022 Published: 02-Feb-2023

© 2023 Indian Journal of Ophthalmology | Published by Wolters Kluwer - Medknow

 February 2023 Varman, et al.: Visual outcomes with low energy SMILE
might be attributable to the interface irregularity and haze in
the early postoperative period in SMILE.[14‑16]
However, with recent practices of optimizing the energy
settings in low‑energy SMILE, visual outcomes in the early
postoperative period have been comparable to those of
FS‑LASIK.[17,18]
This study aimed to analyze the safety and efficacy of using
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low‑energy SMILE for the correction of myopia and myopic
astigmatism, including conditions involving high cylinders
(>3 Dcyl).
YQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8KKGKV0Ymy+78= on 08/31/2023
Methods
The study was a retrospective analysis of the outcomes of eyes
that underwent SMILE between January 2017 and December
2021 at a private practice setting located in Chennai, Tamil
Nadu, India.
The inclusion criteria were patients with myopia
between −0.5 and −10 D and myopic astigmatism between
−0.25 and −5 Dcyl. For preoperative workup, routine recording
of vision using Snellen’s visual acuity chart was performed. All
patients in the study had a preoperative best‑corrected visual
acuity of 6/6 in both eyes. Refraction was recorded meticulously
by performing manual cycloplegic refraction, followed by
confirmative subjective refraction, which included the use of
Jackson’s cross cylinder to confirm the magnitude and vector
of astigmatism and a duochrome to balance the sphere. This
process was repeated by two experienced examiners, and the
patient’s final subjective acceptance was recorded. Refraction
was also recorded using the iTrace aberrometer to confirm
whether or not there were any significant discrepancies. All
patients were aged above 18 years and had a stable refractive
error for at least 1 year. The central corneal thickness was
measured. All patients included in the study had central corneal
thickness within normal limits (minimum 480 µm).
Corneal topography was performed preoperatively for
all patients. The Costruzione Strumenti Oftalmici Sirius
Topographer Model‑13071866 was used to obtain topography
of the cornea. All patients in the study had a topography that
was amenable to laser refractive correction. Fundoscopy was
performed for all the patients through binocular indirect
ophthalmoscopy to rule out retinal issues that are commonly
associated with high myopia. The exclusion criteria included
patients who did not have a best‑corrected visual acuity of
20/20. Patients with corneal, lenticular, and retinal pathologies
noted on examination were deferred from the procedure.
Patients were assessed for the presence of dry eyes and ocular
surface disease and treated for the same if present.
The tenets of the Declaration of Helsinki were followed,
and institutional ethics approval was obtained from the ethics
committee. Informed consent was obtained from all patients
before the procedure.
All procedures were performed by a single experienced
surgeon. The VisuMax 500 laser system (Carl Zeiss Meditec
AG, Jena, Germany) was utilized for all the procedures. The
repetition rate of the laser was 500 kHz, and pulse energy
was 110 nJ. The lenticule diameter was set at 6.5 mm, the cap
diameter was 7.20 mm, and the intended cap thickness was
110–130 m. The spot distance was 4.5 µm. The track distance was
477
2.0 µm. Both the anterior and posterior cut surfaces were spiral.
The length of the side cut was 2.5 mm. The incision position
was 120°. The incision angle was 40°. After laser application,
the intended refractive lenticule was dissected meticulously
through the side cuts and gently peeled away with forceps.
No intraoperative complications of SMILE such as retained
lenticule fragments, tears of incision, or improper dissection
were observed. After surgery, all the patients received a
topical antibiotic–steroid eye drop combination for 1 week,
followed by steroid drops alone for 4 weeks along with the
use of topical lubricants throughout the day on a need basis.
All patients were evaluated immediately postoperation and on
postoperative days 1, 8, and 30. In all visits, the patients were
evaluated for postoperative refractive outcome, uncorrected
visual acuity, aberrometry, and topography estimated using
the iTrace aberrometer.
Results
Overall, 541 eyes of 144 females and 126 males were included.
Table 1 shows the demographics of the patient population.
The average age of the patients was 25.03 ± 4.10 years. The
mean spherical error was 3.76 ± 1.84 Ds. The mean cylinder
was 1.24 ± 0.91 Dcyl. The mean pachymetry was 537 ± 42 µm.
Table 2 summarizes data on treatment efficacy. All patients
achieved 6/6 vision on postoperative day 1. The mean spherical
equivalent of refraction was −4.22 ±1.94 D. The mean spherical
equivalent at 1 month was 0.28 ± 1.06 D.
Fig. 1, Graph A shows the cumulative Snellen’s chart
of the preoperative and postoperative vision. All patients
achieved a UDVA of 20/20 by postoperative day 30. Graphs
B and C illustrate treatment safety, indicating that there was
no loss of Snellen’s lines after the procedure. Fig. 2, Graph D
shows a scatterplot of the attempted versus achieved mean
spherical equivalent. Graph E shows the accuracy of Mean
Spherical Equivalent (MSE) to the target 95% within ±0.50
D. Graph F illustrates treatment accuracy for up to 30 days
after the surgery. The results were maintained at 30 days
postoperation. Fig. 3, Graph G shows a representation of the
preoperative and postoperative astigmatism, and all patients
had postoperative astigmatism within 0.5 Dcyl. Graph H
demonstrates the difference between the target and surgically
Table 1: Demographics of the patient population
Sex, Females/Males 144/126
Age, years 25.03±4.10
Mean sphere −3.76±1.84
Mean cylinder −1.24±0.91
Mean spherical equivalent −4.22±1.94D
Pachymetry 537±42
Table 2: Efficacy of the treatment
Total number 20/60 20/40 20/30 20/20
of eyes=541
POD 0 108 (20%) 400 (74%) 32% (33)
POD 1 541 (100%)
POD 8 541 (100%)
POD 30 541 (100%)
 478 Indian Journal of Ophthalmology Volume 71 Issue 2
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A B C
Figure 1: Graph A: Cumulative Snellen’s chart of the preoperative and postoperative vision. All patients achieved a UDVA of 20/20 by postoperative
day 30. Graph B: CDVA and postoperative CDVA at 30 days. No loss of Snellen’s lines. Graph C: No eyes had any change of Snellen’s lines
after the procedure

D E F
Figure 2: Graph D: Scatterplot of the attempted versus achieved MSE. Graph E: Accuracy of MSE to the target; 95% had it within ±0.50 D.
Graph F: Accuracy of the treatment for up to 30 days after the surgery. The results were maintained at 30 days postoperation

G H I
Figure 3: Graph G: Preoperative and postoperative astigmatism, and all patients had postoperative astigmatism within 0.5 Dcyl. Graph H: Difference
between target‑induced astigmatism and surgically induced astigmatism. Graph I: Angle of error of correction of astigmatism. Eighty‑eight percent
of eyes had an angle between −5 and 5 degrees
 February 2023 Varman, et al.: Visual outcomes with low energy SMILE
induced astigmatism. Graph I shows the angle of error of
correction of astigmatism. Eighty‑eight percent of eyes had an
angle between −5 and 5 degrees
Discussion
The results of the present study showed that SMILE when
performed in a low‑energy setting (110 nJ) was safe and aided
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in vision recovery at a faster rate, i.e., on postoperative day 1.
No intraoperative complications such as black spots, opaque
bubble layer, or difficult dissection were observed. We were
also able to accurately treat high cylinders (>3 Dcyl) without
any cyclotorsional compensation incorporated. All patients
YQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8KKGKV0Ymy+78= on 08/31/2023
achieved 20/20 vision on postoperative day 1. The results were
maintained for up to 30 days.
The efficacy of SMILE in the correction of myopia and
myopic astigmatism is currently well established, with the
results being comparable to those of FS‑LASIK.[19‑22] Studies
have shown that SMILE offers greater biomechanical stability
over FS‑LASIK, which suggests a less frequent incidence of
post‑LASIK ectasia.[14] The smaller incision size has also led
to a lower incidence of postoperative dry eyes.[23,24] SMILE
also demonstrated better‑wound healing and lesser response
to inflammation than FS‐LASIK.[25] The inflammation is said
to settle in the first week after the procedure. Moreover, a
lesser degree of keratocyte apoptosis, tissue proliferation,
and inflammation are the key features that provide SMILE
an edge over FS‐LASIK. During the earlier days of adopting
SMILE, vision recovery was found to be delayed as compared
to that in FS‑LASIK. However, with recent advances in our
understanding, studies suggest that the use of low‑energy
settings leads to outcomes that are comparable to those of
FS‑LASIK in the early postoperative period.[8,9] In our study,
we used a low‑energy setting of 110 nJ, and it was applied for
each eye. After multiple attempts at various energy settings,
we found that 110 nJ was the lowest setting with which we
were comfortably and safely able to complete the procedure.
No black spots, opaque bubble layer, or difficult dissection
were encountered. All patients achieved UDVA 20/20 as early
as postoperative day 1. We attribute this finding to the lower
energy settings used.
Another point to be addressed about SMILE is the lack of
cyclotorsional compensation when the patient moves from the
standing to the supine position. This calls into question the
efficacy of SMILE for the treatment of astigmatism without
a compensatory mechanism. Studies have incorporated a
compensatory mechanism to consider the cyclotorsion of the
eye. Ganesh et al.[26] described a technique for compensating the
cyclotorsion by making limbal markings at 0° and 180°, which
could serve as reference marks for identifying cyclotorsion
when the patient was placed in the supine position. This
technique was successfully able to correct a mean preoperative
cylinder of −2.48 D to a postoperative cylinder of −0.31 D. Jun
et al.[27] described a triple centration technique of marking two
points at the horizontal meridian 7 mm apart and one mark
bisecting the first Purkinje image. Our study was comparable
with the past studies performed with regard to the overall safety
and efficacy of the procedure for the correction of refractive
errors including myopic astigmatism >3 Dcyl. In our study, no
compensatory mechanism for the cyclotorsional movement
of the eye was applied to our patients; yet, we could achieve
479
satisfactory postoperative visual outcomes. We attributed this
finding to the meticulous preoperative refraction to confirm the
vector and magnitude of astigmatism to be treated.
Our study indicated that the use of lower energy settings in
SMILE can contribute to earlier visual recovery. Additionally,
this study indicates that high cylinders (>3 Dcyl) could be
accurately corrected without incorporating a system for
cyclotorsion compensation. The drawback of this study is the
lack of long‑term follow‑up. We could conduct a follow‑up
of all patients until postoperative day 30, after which it was
difficult to convince the patients to attend regular follow‑up
visits.
Conclusion
In conclusion, SMILE shows successful outcomes when used
for the treatment of myopia and myopic astigmatism. The use
of low‑energy settings contributes to faster visual recovery
compared to those in FS‑LASIK. High cylinders can be treated
without the need for cyclotorsional compensation. Further
studies are needed to better understand the optimal energy
settings for SMILE.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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