Resume Tugas Akademik 8-Journal Reading 5-REF

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Raissa Vaniana Hartanto

PPDS IK Mata Semester 5

RESUME TUGAS AKADEMIK 8/ dr.RAISSA VANIANA HARTANTO


JOURNAL READING 5 / REFRAKSI

Judul Jurnal : Randomized Clinical Trial Comparing


Femtosecond LASIK and Small-
Incision Lenticule Extraction
Latar Belakang : Currently, LASIK is the most popular laser
refractive surgery technique, with good visual
outcomes, rapid postoperative recovery, and good
safety profile. As such, LASIK has been reported by
the American Academy of Ophthalmology as an
established, safe, and effective treatment for myopia
with rapid postoperative visual improvement,
minimal patient discomfort, and good long-term
refractive stability.
Small-incision lenticule extraction (SMILE), recently
approved by the United States Food and Drug
Administration for the treatment of myopia and
myopic astigmatism, is a flapless laser refractive
technique that uses a single femtosecond laser system.
The potential advantages of this minimally invasive
SMILE technique over traditional femtosecond
LASIK include reduced iatrogenic dry eye, a
biomechanically stronger postoperative cornea with a
smaller incision, and reduced laser energy required for
refractive corrections.
Although SMILE is rapidly gaining popularity in the
United States and many parts of Asia, the number of
cases is still far fewer than that for other laser
refractive procedures; hence, it is important to study
its outcomes and safety compared with an established
LASIK technique in a well conducted clinical trial.
Thus, we conducted a paired-eye randomized
controlled trial comparing SMILE and LASIK in
the same patient, with the main advantage being
that the patient was the objective subject of
assessment in terms of visual outcomes.
Tujuan : To compare femtosecond LASIK with small-
incision lenticule extraction (SMILE) for the
treatment of myopia and myopic astigmatism
Metodologi : Prospective, randomized, single-masked, paired-
eye study design, 70 patients, May 2014 –
November 2016, Singapore National Eye Center
All participants were randomized to undergo either
SMILE or LASIK first in each eye. The main outcome
measure was refractive predictability after surgery,
achieving a postoperative spherical equivalent (SE)
within  0.50 diopter (D) and 1.0D of the intended
target. Our secondary outcome measures included
UDVA, CDVA, Refractive Astigmatis, contrast
sensitivity, and HOA after surgery. Statistical Package
for the Social Sciences version 17.0 (SPSS, Inc,
Chicago, IL) was used to analyze the data. A P value of
less than 0.05 was considered significant.
Hasil : We recruited 70 consecutive patients (mean age, 285
years; 64% women; all Asian) with no difference
in preoperative spherical equivalent (SE) between eyes
(-5.31.8 diopters [D] vs. -5.2 1.7 D; P = 0.87). At 3
months, 99% of SMILE eyes and 97% of LASIK eyes
achieved SE within1.0 D of attempted correction (P=
1.0). Small-incision lenticule extraction achieved
similar results as LASIK in terms of efficacy index
(0.97 0.20 vs. 0.99 0.20; P=0.56), uncorrected
distance visual acuity (UDVA) of 20/40 or better
(100% vs. 100%; P=1.0), and UDVA of 20/20 or better
(84% vs. 87%; P=0.63). Safety index (1.10.2 vs. 1.1
0.2; P=0.57) was similar between SMILE and LASIK
eyes at 3 months. At 12 months, SMILE was similar to
LASIK in terms of efficacy (85% vs. 83%
UDVA>20/20; P=0.81), predictability (99% vs. 99% _
1.0 D of attempted correction SE; P =1.0), and safety
(1.150.20 vs. 1.150.20; P,c0.93).
Kesimpulan SMILE produced promising refractive outcomes in
terms of predictability, efficacy, and safety at 3 and 12
months of follow-up.

Rangkuman dan Hasil The results from this clinical trial suggest that SMILE
Pembelajaran is a promising laser refractive surgery technique in
terms of safety and refractive outcomes. It would be
difficult to demonstrate that a new technique such as
SMILE is superior.
However, as surgical nomograms and refinement of
surgical techniques are being developed, clinical
outcomes after SMILE would likely improve over
time. Current literature suggests that the refractive
outcomes and safety of SMILE and LASIK are
similar, but many of these studies are not comparative
studies, with few randomized trials. Studies on quality
of vision and questionnaires also suggest that SMILE
is similar to LASIK in terms of patient satisfaction
without using a paired-eye study design, leading to
subjective differences between patient-reported
outcomes between groups. However, when
generalizing these trial results to other populations, it
is important to recognize that SMILE is a refractive
technique that is more surgeon dependent compared
with LASIK. Thus, reducing intersurgeon variability
through adequate training and experience is important
for SMILE to become a safe and effective
alternative to LASIK.

Pembimbing,

dr. Fatimah Dyah Nur Astuti,MARS, SpM (K)

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