Taiwan Journal of Ophthalmology 4 (2014) 156e162

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Taiwan Journal of Ophthalmology

journal homepage: www.e-tjo.com

Original article

Outcome of a 10-year follow-up of laser in situ laser keratomileusis

for myopia and myopic astigmatism
Takeshi Ide a, b, *, Ikuko Toda a, b, Teruki Fukumoto a, c, Junichi Watanabe a, Kazuo Tsubota b
a
Minamiaoyama Eye Clinic, Tokyo, Japan
b
Department of Ophthalmology, School of Medicine, Keio University, Tokyo, Japan
c
Department of Ophthalmology, National Defense Medical College, Saitama, Japan

a r t i c l e i n f o a b s t r a c t

Article history: Purpose: To evaluate the results of laser in situ laser keratomileusis (LASIK) for myopia/myopic astig-
Received 19 March 2014 matism over a 10-year period.
Received in revised form Methods: We examined LASIK patients who received regular postoperative assessments over 10 years.
5 June 2014
We evaluated uncorrected visual acuity (UCVA), manifest refraction, best-corrected visual acuity, intra-
Accepted 23 June 2014
Available online 18 September 2014
ocular pressure, retreatment rate, safety, efcacy, and complications.
Results: We studied 5423 eyes between December 1997 and February 2002. The study criteria were met
by 346 eyes. A UCVA of 20/40 was achieved in 86.1% of the patients, with 52.0% achieving 20/20 at 10
Keywords:
astigmatism years. Refraction within 1.00 s of target was achieved in 76.3% of the patients, and 95.7% were within
follow-up studies 2.00 s at 10 years. Retreatment was required in 124 eyes (35.8%). The preoperative logMAR UCVA of 1.24
laser in situ laser keratomileusis improved to
0.08 at 1 month, and slightly decreased to 0.06 at 10 years. The safety and efcacy indices
myopia were 1.0 and 0.89 at 1 month, and 0.99 and 0.71 at 10 years.
Conclusion: We analyzed 6.3% of patients who regularly returned for postoperative examinations.
Despite the relatively low 10-year-visit rate and the inclusion of single- and multiple-treatment cases,
our results may represent the real-world picture of LASIK; furthermore, our study shows that LASIK is an
effective and safe procedure.
Copyright 2014, The Ophthalmologic Society of Taiwan. Published by Elsevier Taiwan LLC. All rights
reserved.

1. Introduction longer-term outcomes.10e13 The aim of this study was to evaluate

Laser in situ laser keratomileusis (LASIK) was introduced in the
early 1990s and became the most-performed refractive surgery in
the 2000s.1
Since refractive surgery is performed mostly in young and
healthy eyes of patients with high expectations, its long-term safety
and efcacy are of great concern.2 The efcacy and safety of LASIK
have been reported by several investigators; however, most of
these reports have summarized postoperative outcomes over a
relatively short period.3e8
We have performed LASIK at our institute since 1997 and have
attempted to follow-up and record the postoperative course.
We previously reported the efcacy and safety of LASIK over a
5-year postoperative period.9 There are only a few reports of
Conicts of interest: The authors declare that they have no conicts of interest.
* Corresponding author. Minamiaoyama Eye Clinic, Renai Aoyama Building 4F, 3-
3-11, Kitaaoyama, Minato-ku, Tokyo 107-0061, Japan.
E-mail address: teyede@minamiaoyama.or.jp (T. Ide).
the 10-year safety, efcacy, and stability of myopia/myopic astig-
matism LASIK performed in our clinic.
2. Materials and methods
2.1. Patient population
At our clinic, we performed LASIK on 26,604 eyes in 13,595
patients from 1997 until the end of 2009, and 5423 eyes with
myopia/myopic astigmatism between December 1997 and
February 2002. Of the 5423 eyes, 182 patients (346 eyes) regularly
returned for follow up and were enrolled in this study. Our exclu-
sion criteria for the study were previous ocular surgery, corneal
diseases, glaucoma, history of ocular trauma, and insufcient
corneal thickness for laser ablation, or preoperative detection of
forme fruste keratoconus (FFKC). Eyes with endothelial cell counts
below 1500 cells/mm2 were also excluded. Patient demographics
are summarized in Table 1. The study was conducted in accordance

http://dx.doi.org/10.1016/j.tjo.2014.06.002
2211-5056/Copyright 2014, The Ophthalmologic Society of Taiwan. Published by Elsevier Taiwan LLC. All rights reserved.
 T. Ide et al. / Taiwan Journal of Ophthalmology 4 (2014) 156e162
Table 1
Demographics of patients included in this study.
Sex Male: 101 cases 191 eyes
Female: 81 cases 155 eyes
Age (y) 34.9 8.1 (18 to 67)
Refraction
6.42 2.70 s (
0.5 to
15.0)
Astigmatism
0.95 0.91 s (0 to
5.5)
Mean optical zone 6.09 0.25 mm (5.0 to 6.5)
UCVA (LogMAR) 1.24 0.06 (0 to 2)
BCVA (LogMAR)
0.16 0.08 (
0.2 to 0.3)
BCVA best-corrected visual acuity; UCVA uncorrected visual acuity.
with the tenets of the Declaration of Helsinki. Written informed
consent was obtained from all the patients.
2.2. Surgical technique
LASIK was performed by our surgeons, using the same technique
with minor variations. A corneal ap was created using LSK-One
(Moria, Antony, France; 229 eyes), Flapmaker (Solan Ophthalmic
Products, Jacksonville, FL, USA; 3 eyes), or MK-2000 (Nidek, Aichi,
Japan; 114 eyes) microkeratome. The residual bed thickness (RBT)
was measured using the AL-2000 pachymeter (Tomey, Aichi,
Japan), although this intraoperative measurement was not per-
formed in the earlier cases.
As a custom treatment was unavailable during this period,
conventional ablation was performed using the APEX PLUS
(Summit, Waltham, MA, USA; 81 eyes) or EC-5000 (Nidek; 265
eyes) excimer laser system. In some cases, undercorrection was
employed as requested by the patient, but these cases were
excluded from this study. After surgery, a low-dose steroid (0.1%
uorometholone; Santen, Osaka, Japan) and a quinolone anti-
biotic (Tarivid or Cravit; Santen) were prescribed ve times/day
for the 1st postoperative week. For dry eye care, we prescribed
0.3% preservative-free hyaluronic acid (Hyalein mini; Santen)
eye drops ve times/day for the 1st postoperative week. Subse-
quently, we continued the same regimen, switching to less 0.1%
hyaluronic acid and/or saline eye drops, or stopping antiedry-
eye medication, depending on the patients' ocular conditions.
2.3. Retreatments
Retreatments after LASIK were performed by relifting the ap.
Disposable contact lens were placed and then removed on post-
operative Day 1. The postoperative eye drop regimen was the same
as that for the primary surgery.
2.4. Postoperative evaluation
Postoperative examinations were performed at 1 day, 1 week, 1
month, 3 months, and 6 months, and 1 year, 2 years, 3 years, 4
years, 5 years, and 10 years after surgery. In this study, we analyzed
the postoperative data at 1 month, 3 month, and 6 months and 1
year, 5 years, and 10 years. Patient visits were not usually at precise
time points; therefore, 1e3 years, 4e7 years, and 8e10 years
postoperatively were regarded as 1 year, 5 years, and 10 years,
respectively. Uncorrected visual acuity (UCVA), best-corrected vi-
sual acuity (BCVA), manifest refraction, intraocular pressure (IOP),
and complications were investigated.
Data were obtained at the end of 10 years and evaluated
retrospectively, including the following safety and efcacy
indices: safety BCVApost/BCVApre; efcacy UCVApost/
BCVApre.
157
2.5. Statistical analysis
Data analysis was performed using SPSS 18 (SPSS Inc., Chicago,
IL, USA). A p-value <0.05 was considered statistically signicant.
3. Results
3.1. Overall result
In this study, 222 eyes of 125 patients underwent single treat-
ment (64.2%), and 124 eyes of 75 patients had two or more treat-
ments (35.8%).
3.2. Refractive change, predictability, and stability
The manifest spherical equivalent (SE) of
6.42 2.70 s pre-
operatively improved to 0.06 0.53 s at 1 week,
0.05 0.51 s at 1
month,
0.18 0.62 s at 3 months,
0.16 0.55 s at 6
months,
0.15 0.53 s at 1 year,
0.38 0.69 s at 5 years,
and
0.67 0.92 s at 10 years. Postoperatively, the mean SE was
stable and showed slight regression over 10 years (Figs. 1 and 2).
The percentage of eyes for which a UCVA of 20/40 was achieved
was 86.1%, with 52.0% achieving 20/20. At 10 years, 76.3% of eyes
achieved refraction within 1.00 s of target and 95.7% were within
2.00 s of target.
The scattergrams of attempted versus achieved correction at 1
month and 10 years postoperatively are illustrated. These graphs
show that the higher refractive error cases tend to be under-
corrected and that the R2 number is smaller at 10 years than at 1
month, which indicates refractive regression. The timing for
enhancement was 5.8 3.5 years after the primary surgery.
The safety (BCVApost/BCVApre) and efcacy (UCVApost/BCVApre)
indexes were 1.0 0.17 and 0.89 0.23, 1.0 0.16 and 0.86 0.24,
1.02 0.17 and 0.89 0.24, 1.04 0.15 and 0.89 0.22, 1.01 0.16 and
0.8 0.27, and 0.99 0.18 and 0.71 0.31 at 1 month, 3 months, 6
months, 1 year, 5 years, and 10 years, respectively (Fig. 3).
In addition to this trend graph, the scattergrams of attempted
correction vs. safety or efcacy at 1 month and 10 years post-
operatively are illustrated (Figs. 4 and 5). The safety approximation
lines are located at almost 1 at 1 month and 10 years (Fig. 4). The
efcacy lines, however, tended to be lower with higher correction
cases both at 1 month and 10 years, and lower at 10 years than at 1
month (Fig. 5).
In Fig. 1B, two cases showed considerable regression of refrac-
tion. The rst case was of a 17-year-old man who requested for
LASIK surgery. We usually perform LASIK surgery in patients above
18 years; however, in July 2011, we performed surgery for both his
eyes because he needed a good UCVA score to become a policeman.
The preoperative refraction data were OD S
10.0 s C
1.0
DA  170 and OS S
9.5 s C
3.0 DA  180, and the pachymetry
was OD 558 mm and OS 562 mm, respectively. He underwent regular
checkups. In November 2001, the vision and topography were
within normal limits. At the examination in March 2008, his right
eye logarithm of the minimum angle of resolution (logMAR) BCVA
was 1, the refraction was S
6.0 s C
5.5 DA  160, and the
topography showed ectatic change.
The second case involved cataract formation 10 years after LASIK
surgery. The patient had bilateral LASIK surgery at the age of 45 in
November 1999, and was stable with plano SE manifest until April
2005 without any cataract sign. At the examination in September
2009, slit-lamp examination showed nuclear cataract formation.
The refraction was OD S
5.5 s C
0.75 DA  40 and OS S
0.5 s
and logMAR BCVA was OD (0.2) and OS (
0.1) respectively. We
performed multifocal intraocular lens surgery in her right eye, with
visual result of logMAR UCVA
0.1.
158 T. Ide et al. / Taiwan Journal of Ophthalmology 4 (2014) 156e162

Fig. 2. Mean value of the spherical equivalent (SE): manifest refraction decreased
gradually after surgery. Small but statistically signicant regression up to 10 years.

versus IOP reduction showed a trend toward higher treatments

causing greater reductions in IOP, although this correlation was not
statistically signicant (Fig. 10).

3.5. Complications

Diffuse lamellar keratitis (DLK) was observed in six eyes (2.0%),

but all were managed with intensive steroid eye drop treatment

Fig. 1. Scattergram of attempted and achieved correction at each time point: (A) 1
month and (B) 10 years after laser in situ laser keratomileusis surgery for the 346 eyes.

3.3. Visual acuity

The UCVA logMAR of the patients was 1.24 0.29 preoperatively

and improved to
0.03 0.18 on Day 1 and
0.07 0.16 at 1 week,
and reached
0.08 0.16 at 1 month,
0.06 0.2 at 3
months,
0.08 0.17 at 6 months,
0.09 0.15 at 1
year,
0.02 0.2 at 5 years, and 0.06 0.26 at 10 years. Fig. 6 shows
very small but continuous and statistically signicant decreases in
UCVA, reaching 0.06 0.26 at 10 years after surgery.
The nal BCVA at the 10-year examination improved by two
lines in ve eyes (1.4%) and was unchanged in 325 eyes (93.9%).
However, 15 eyes lost two lines (4.6%) of BCVA (Figs. 7 and 8).

3.4. IOP

The IOP was 13.4 2.5 mmHg preoperatively. It decreased to

9.6 1.9 mmHg at 1 week and 9.6 2.5 mmHg 1 month after Fig. 3. Safety and efcacy index of laser in situ laser keratomileusis surgery up to 10
surgery and did not change thereafter (Fig. 9). The scattergram of SE years. (A) Safety. (B) Efcacy.
 T. Ide et al. / Taiwan Journal of Ophthalmology 4 (2014) 156e162
Fig. 4. Scattergram of attempted correction and safety index at each time point: (A) 1
month and (B) 10 years after laser in situ laser keratomileusis surgery for 346 eyes.
without surgical intervention. Microstriae resembling ngerprint
lines were observed in the ap in 48 eyes (13.87%), and epithelial
ingrowth was seen in 23 eyes (6.65%) and two keratoectasia cases
(0.58%). Some of these cases with microstriae and ingrowth, which
Fig. 5. Scattergram of attempted correction and efcacy index at each time point: (A) 1
month and (B) 10 years after laser in situ laser keratomileusis surgery for 346 eyes.
159
Fig. 6. Changes in uncorrected visual acuity (UCVA). The UCVA (logMAR) improved at
1 day and was stable until 5 years after surgery. Thereafter, UCVA showed a minimal
but statistically signicant decrease.
affected the vision and/or corneal topography, underwent relifting
and extending aps.
3.6. Comparison between single treatment group and retreatment
group
Next, samples were divided into two groups (single treatment
group and retreatment one), and the data were analyzed for UCVA,
BCVA, and manifest SE. The preoperative data and the post-
operative course were summarized. Preoperative UCVA, BCVA, and
manifest SE were not statistically different (Table 2). Postoperative
courses showed difference in UCVA and SE at some time points, but
not in BCVA (Fig. 11).
4. Discussion
In this study, we have shown the 10-year outcomes of LASIK in
myopia/myopic astigmatism patients performed in a single clinic.
Post-LASIK refractions were stable for a long time after the
initial surgery, although minimal regression was observed. Myopic
regression is a universal phenomenon following excimer laser
correction.14 Previous studies with <1 year of follow-up found an
average regression rate ranging between
0.50 s and
1.15 s after
Fig. 7. Changes in best-corrected visual acuity (BCVA). The BCVA (logMAR) improved
at 1 day and was stable until 10 years after surgery.
160 T. Ide et al. / Taiwan Journal of Ophthalmology 4 (2014) 156e162

Table 2
Preoperative data for patients undergoing single and multiple surgeries.

Single treatment Retreatment p

UCVA 1.24 (0.29) 1.27 (0.29) 0.453

BCVA
0.14 (0.08)
0.14 (0.07) 0.807
Manifest SE
6.59 (2.9)
6.13 (2.27) 0.101

BCVA best-corrected visual acuity; SE spherical equivalent;

UCVA uncorrected visual acuity.

creation and reduced structural corneal integrity, attributable to

excessive ablation, which may lead to progressive corneal ectasia.23

et al implied that myopic regression increases with higher
Alio
corrections.11 Likewise, we found similar correlation, suggesting
that myopic regression increased with higher corrections. Addi-
tionally, the mean age of patients included in the present study at
10 years was 44.9 years, and the natural history of age-related
Fig. 8. Changes in best-corrected visual acuity (BCVA). The frequency of eyes with
changes may need to be considered when assessing refractive
BCVA that lost two lines was 4.6% at 10 years after laser in situ laser keratomileusis
surgery.

Fig. 9. Changes in intraocular pressure (IOP), which decreased by about 4 mmHg at 1

week after surgery and remained stable thereafter.

laser correction of high myopia.2,5,8,15e22 There are many reasons

for myopic regression, including epithelial hyperplasia, corneal
steepening, changes in corneal biomechanics, increases in axial
length, and lenticular sclerosis.14,20,21 Other studies have suggested
that regression in high myopic eyes can occur because of ap

Fig. 11. Postoperative time-course change in (A) uncorrected visual acuity, (B) best-
Fig. 10. Scattergram of corrected power and the IOP reduction at postoperative 3 corrected visual acuity, and (C) spherical equivalent of the single treatment and
months. retreatment groups.
 T. Ide et al. / Taiwan Journal of Ophthalmology 4 (2014) 156e162
stability.24 In this Beaver Dam study, signicant changes occurred
in SE over a 10-year period in adults. Younger people became more
hyperopic, whereas older people became more myopic. Severity of
nuclear sclerosis was also strongly related to amount of change.24
Based on the Beaver Dam study, we can speculate that the early
postoperative plateau period is due to the good balance between
refractive regression and hyperopic shift in younger patients, and
that later myopic shift is due to an additive effect of refractive
regression and myopic shift in older patients. However, the age
range of patients is different but overlapping (our study, 18e67
years; Beaver Dam study, 43e84 years).24 Recent advances in laser
proles and technologies should be taken into account when
comparing these results with those of more recent procedures.
Our overall retreatment rate was 35.8%, which was similar to
that in previous reports of laser refractive surgery for myopia, with
r-treatment rates between 30% and 40% after photorefractive ker-
atectomy or LASIK.2,16e22 The main reason for retreatment was
dissatisfaction with the visual result. Although it is not always easy
to provide clear reasons for retreatments, in this study, reasons
were classied as primary undercorrection in 17 (13.7%) of 124
eyes, and regression in 107 eyes (86.3%).
Interestingly, in a previous study, patients with moderate to
high myopia underwent minimal retreatments over 7 years
(0e0.5%). However, in this study, there was no symptomatic in-
crease in myopic regression to warrant a higher retreatment rate in
the high myopic group. In individuals with high myopia, the lower
retreatment rates may be attributed to the lack of residual stroma;
however, we are unable to conrm this. Another reason for the
lower retreatment rates in high myopes may be patient satisfaction
with a large improvement in refractive errors and functional vision.
The efcacy results of this study were inferior to those of the
study based on the data submitted to the Food and Drug Admin-
istration (FDA),25 which reported that 97% achieved a postoperative
UCVA of 20/40, and 62% of the eyes achieved 20/20 UCVA (86.1% for
20/40 and 52.0% for 20/20 at 10 years in our study). However, our
results are comparable to previous studies of LASIK for high
myopia, which show that 46e78% of eyes achieved UCVA of 20/40
or better after 6 months of follow-up.2,5,8,15e22
Regarding the visual outcomes, the safety index was good (0.99),
which is comparable with the safety index of 1.08 in a large, long-
term study.11 The efcacy index was 0.71, which is inferior to 0.88 in
a large, long-term study.11
We found that 76.3% of eyes were within 1.00 s and 95.7% were
within 2.00 s, 10 years after LASIK. Our results are superior to
those of previous short-term follow-up studies of LASIK for high
myopia, which found that between 30% and 60% of eyes were
within 1.00 s after surgery2,5,8,15e22; however, our results are
inferior to the data from FDA trials, which show that 72% of eyes
achieved a refractive error of 0.50 s of the intended correction and
90% of eyes were within 1.00 s of the target.26
We have to admit that our study had a critical problem: it
included single-treatment as well as multiple-treatment cases.
From a different point of view, however, we can conclude that with
or without retreatment, our results present the true picture of the
post-LASIK course. We believe this complexity may apply in clinical
settings, because several patients understand the need for
retreatment and would like to be aware of the long-time results
with or without retreatments.
Regarding complications, our results were similar to those of
previous reports.27e29 In our study, the 15 eyes (4.6%) with loss of
BCVA of two lines were possibly associated with the following: the
progression of cataracts, keratoectasia, and epithelial impairment
due to dry eye; however, we were unable to identify any obvious
reason in several cases. There was a low rate of loss in BCVA in the
FDA trials (from 1993 to 2002), with a range of 0% and 4.5% of eyes,
161
losing two lines of BCVA.26 Previous studies have shown that
corneal ectasia usually develops in the rst 2 years after LASIK, and
identied high myopia, FFKC, low RBT, and multiple enhancements
as risk factors for the development of ectasia.30,31 Accordingly, in
our study, two eyes developed corneal ectasia detected at 1 year
and 2 years after LASIK, respectively. These two eyes underwent
LASIK for extremely high myopia (
15 s and
11 s), with planned
postoperative total corneal thickness over 400 mm. Neither of these
two cases had preoperative FFKC on the corneal topography. In the
early cases at our clinic, we did not perform intraoperative pachy-
metry measurement. Therefore, deviations from the mean depth of
the microkeratome pass may have created thicker aps with lower
RBT than intended. We experienced two keratoectasia cases, and
the rate (0.58%) is higher than that reported by Randleman et al
(0.04%).30
The mean postoperative IOP dropped by 4.04 mmHg at 1 month
and remained unchanged thereafter, consistent with previous re-
ports.32 We always emphasize to our patients the importance of
receiving regular postoperative examinations up to 10 years;
however, the frequency at which patients visited our institute for
postoperative examinations was 94% at 1 week after surgery, 87% at
1 month, 73% at 3 months, 55% at 6 months, 46% at 1 year, 9.3% at 5
years; this percentage continued to decline thereafter.9 This study
indicated that the frequency of postoperative examination fell to
6.3% at 10 years after surgery. There are many reasons for not
retuning for postoperative examinations. Some approached other
institutes because of personal circumstances. However, the major-
ity of patients simply disregarded our recommendation for follow-
up examinations, probably because they felt there was no need for
follow-up. Thus, it would seem that those who were satised with
the results of the surgery tended to forget or ignore the schedule for
postoperative examinations, whereas those who experienced ir-
regularities in their visual performance frequently came back to the
institute. Therefore, the true incidence of regression, enhancement,
and patient satisfaction among all patients who undergo LASIK is
likely to differ somewhat from what is reported in this study.
Although the relatively low 10-year visit rate (6.3%) may have
biased the results, LASIK surgery can be considered an effective and
safe procedure for the correction of myopia/myopic astigmatism as
long as the inclusion and exclusion criteria are strictly respected
and patients understand the pros and cons of this procedure.
However, regular check-ups are recommended. During this 10-year
study period, we have encountered many technical improvements,
and we will continue to accumulate and analyze data as they
correlate to these changes in technology and report them in a
future study.
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