ARTICLE IN PRESS

Dry eye after refractive surgery: A meta-analysis

Raman-Deep Singh Sambhi, BSc (Hons.),* Gagan Deep Singh Sambhi, BSc (Hons.),y
Rookaya Mather, MD,z Monali S. Malvankar-Mehta, PhDz,x

ABSTRACT 
Objective: To examine and compare the rates of dry eye after various refractive surgeries, including laser-assisted in situ keratomileusis
(LASIK), photorefractive keratectomy (PRK), femtosecond lamellar extraction (FLEx), and small incision lenticule extraction (SMILE).
Study Design: Systematic review and meta-analysis.
Methods: This systematic review and meta-analysis was conducted following the Preferred Reporting Items for Systematic Reviews and
Meta-Analyses statement guidelines. Databases searched included MEDLINE (Ovid), Embase, Cochrane Library, Cumulative Index of
Nursing and Allied Health Literature, Web of Science, ProQuest Dissertations and Theses, and ClinicalTrials.gov. Meeting abstracts
from European Society of Cataract and Refractive Surgeons, American Academy of Ophthalmology, Association for Research in
Vision and Ophthalmology, and Canadian Ophthalmological Society were also examined. Articles underwent 3 stages of screening
before data extraction and meta-analysis.
Results: In total, 3232 studies were found; 261 remained after title screening, 92 remained after abstract screening, and 14 studies pro-
gressed to data extraction. Meta-analysis indicated a significant reduction in tear break-up time (TBUT) with LASIK (standardized
mean difference [SMD] = 0.3; confidence interval [CI]: 0.53 to 0.08) and FLEx (SMD = 1.09; CI: 1.44 to 0.74), and a nonsignif-
icant reduction in TBUT with SMILE (SMD = 0.34; CI: 0.95 to 0.27) and PRK (SMD = 0.11; CI: 0.29 to 0.08). Meta-analysis also
indicated a significant reduction in tear production with LASIK (SMD = 0.23; CI: 0.46 to 0.01), and a nonsignificant reduction
in tear production with SMILE (SMD = 0.04; CI: 0.28 to 0.36), FLEX (SMD = 0.05; CI: 0.37 to 0.28), and PRK (SMD = 0.07;
CI: 0.32 to 0.19).
Conclusions: Overall, a significant reduction in postoperative tear production as well as TBUT time was seen with LASIK, and a nonsig-
nificant reduction in postoperative tear production and TBUT was seen with SMILE, FLEx, and PRK. Ultimately, more high-quality ran-
domized controlled trials are required to make concrete conclusions about dry eye parameters after refractive surgery.

Refractive surgery to correct vision is one of the most com-
mon elective surgical procedures in the United States. As of
2009, over 28 million laser-assisted in situ keratomileusis
(LASIK) procedures have been performed.1 This is in addi-
tion to all of the photorefractive keratectomy (PRK), small
incision lenticule extraction (SMILE), and femtosecond
lamellar extraction (FLEx) procedures also being performed,
both in the United States and globally. Furthermore, the
majority of candidates for refractive surgery are young, active
individuals, generally 2030 years old.2 Refractive surgery is
known to be a safe vision correction option for individuals
wanting to rid themselves of contact lenses and glasses. How-
ever, a common side effect of refractive surgery is dry eye.
Some studies have reported that up to 95% of patients experi-
ence dry eye symptoms after refractive surgery, with a portion
of these individuals experiencing chronic dry eye symptoms,
also known as dry eye disease (DED).3 DED can have major
implications on an individual’s quality of life (QOL) and can
also have a tremendous societal burden.4
DED, sometimes referred to as keratoconjunctivitis sicca,
keratitis sicca, or dry eye syndrome, has a major socioeco-
nomic and QOL impact. Symptoms of DED include blurry
vision, ocular irritation, excessive tearing, ocular hyperemia,
and photophobia, among others. As seen through various
studies, these symptoms can make activities of daily living
quite difficult, degrading QOL.4 In addition, these symp-
toms can have a tremendous socioeconomic cost. This
includes the direct cost of medical care for DED and the indi-
rect costs, such as inability to work and reduced productivity
when at work. Studies have shown that the annual direct
costs of DED in the United States are US$3.84 billion, and
the annual indirect costs are as high as US$55.4 billion.4
Consequently, it is crucial to understand the rates of dry eye
and DED after the various refractive surgical procedures to
adequately understand the potential impacts it can have.
The rate of dry eye and DED after refractive surgery is a
pertinent topic to explore. With numerous individuals under-
going refractive surgery procedures every year, with many of
the patients being young and healthy, it is important to know
the incidence of dry eye after the various procedures. This
improved understanding of the prevalence of dry eye after
refractive surgery can help physicians better predict and man-
age patient outcomes, potentially alleviating the negative
QOL and socioeconomic impacts of postrefractive surgery
dry eye. Although several studies have compared the rate of
dry eye in some of the refractive surgery techniques, to our
knowledge, there is no systematic review and meta-analysis
comparing the rates of dry eye after all of the current popular
refractive surgeries to one another (LASIK, PRK, SMILE,
and FLEx).

© 2019 Canadian Ophthalmological Society.

Published by Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.jcjo.2019.07.005
ISSN 0008-4182

CAN J OPHTHALMOL—VOL. &, NO. &, & 2019 1

 ARTICLE IN PRESS
Dry eye after refractive surgery: A meta-analysis—Sambhi et al.
The objective of this systematic review and meta-analysis is
to consolidate all of the current literature regarding the rates
of dry eye after patients undergo any of the current common
refractive surgeries. The procedures this article focuses on are
LASIK, PRK, FLEx, and SMILE.
TAGEDH1METHODSTAGEDEN
Search Strategy/Design
This systematic review and meta-analysis was conducted
following the guidelines of the Preferred Reporting Items for
Systematic Reviews and Meta-Analyses statements. Several
databases and grey literature sources were searched to find rel-
evant studies. The databases that were used to find relevant
literature were MEDLINE (OVID), Embase, Cochrane
Library, and Cumulative Index of Nursing and Allied Health
Literature. Search strategies were created for each of the data-
bases (Appendix A, available online), and the searches were all
run until June 20, 2018. Database-specific subject headings
and key words for “refractive surgery,” “dry eye disease,” “kera-
toconjunctivitis sicca,” “keratitis sicca,” and “dry eye syndrome”
were employed in the search strategy. The searches were modi-
fied to accommodate the unique terminology and syntax of
each database. Additionally, all synonyms were taken into
account with the help of an information specialist. Methodo-
logical filters were applied to limit our retrieval to comparative
studies, observational studies, interventional case series, clinical
trials, randomized trials, observational studies, retrospective
studies, prospective cohort studies, and contralateral prospective
studies. OVID AutoAlerts were set up to send monthly updates
with any new literature up until March 1, 2019. Monthly
updates were performed on Health Economic Evaluations
Database, PubMed, and Cochrane Library databases.
Grey literature was obtained by searching Web of Science,
ProQuest Dissertations and Theses, ClinicalTrials.gov, and
the meeting abstracts from the American Society of Cataract
and Refractive Surgeons, European Society of Cataract and
Refractive Surgeons, American Academy of Ophthalmology,
the Association for Research in Vision and Ophthalmology,
and the Canadian Ophthalmological Society.
Inclusion/Exclusion Criteria
Regarding the inclusion criteria for the systematic review,
studies pertaining to both dry eye and any type of refractive
surgery were included in the analysis. Study designs included
in the review were clinical trials, randomized trials, observa-
tional studies, retrospective, and prospective studies. Regarding
exclusion criteria, studies involving patient populations who
had pre-existing dry eye or DED before undergoing refractive
surgery were excluded from the analysis. Studies that looked at
nonhuman subjects, published before 1995, and were non-
English were excluded. Studies that had a sample size of less
than 20 eyes and that involved nonadult subjects (younger
than 18 years) were also excluded. No limits were placed based
on study location or postoperative follow-up periods.
2 CAN J OPHTHALMOL—VOL. &, NO. &, & 2019
Once all of the studies were compiled, the articles were
imported into DistillerSR and duplicates were removed. Next
title screening, abstract screening, and full-text screening
were done to determine which studies were relevant.
Screening
Screening was conducted in 3 stages. DistillerSR from Evi-
dence Partners was used to conduct the screening of the
articles. The studies were screened by 2 reviewers indepen-
dently, and Cohen’s kappa (k) coefficient was computed to
assess the agreement of inclusion between the 2 reviewers (R.
S., G.S.) at each stage of screening. If there were disagree-
ments on inclusion/exclusion, they were resolved mutually.
In the case of disagreements, a third reviewer (M.M.) inter-
vened to provide a decision.
The 3 stages of screening were title screening, abstract
screening, and full-text screening. Detailed screening ques-
tions are provided in Appendix B (available online). At the
title screening stage, studies with titles that did not seem rele-
vant to the topic were excluded. At the abstract screening
stage, studies without abstracts were excluded, in addition to
those that did not appear to be relevant to the topic. During
the full-text screening process, articles that did not have
appropriate information (Schirmer test, tear break-up time,
postsurgery dry eye prevalence, etc.) were excluded.
Study Quality
The final selection of literature that remained after the full-
text screening stage was examined for study quality using a
modified Downs and Black checklist (Appendix C, available
online).5 The parameters that were assessed included report-
ing, external validity, internal validity (bias, and confounding
factors), and power. Each study was given a score out of 28.
Studies were labeled as poor quality if they scored 14, fair
quality if they scored 1519, good quality if they scored
2025, and excellent if they scored 2628. Assessment of
study quality was completed by one individual (R.S.).
Data Extraction
Data extraction from the included articles was completed
by one investigator (R.S.). Information extracted from the
studies that progressed past full-text screening included study
year, design, location, number of patients and eyes, mean
age, visual acuity, percentage of patients with dry eye symp-
toms, main outcome measures of the study, type of refractive
surgery explored in the study, follow-up period(s), risk factors
for dry eye after the various refractive surgeries, and the result
values of tests that assess for dry eye (Schirmer test, tear
break-up time [TBUT], and Ocular Surface Disease Index
[OSDI]). Schirmer’s test and TBUT were more ubiquitous
and therefore utilized for the meta-analysis. Additionally,
these tests provide a more objective measurement of dry eye
symptoms as opposed to the dry eye symptom scales (such as
OSDI, McMonnies Dry Eye Questionnaire). The available
 ARTICLE IN PRESS
Dry eye after refractive surgery: A meta-analysis—Sambhi et al.

data on range, p-value, and CI were used and converted to
the common effect measure, standard deviation.
Meta-Analysis
After the completion of data extraction, the statistical/
meta-analysis was done by one investigator (M.M.). STATA
15.0 (STATA Corporation, College Station, TX) was used to
conduct the meta-analysis. For continuous scale outcomes
including mean values, the standardized mean difference
(SMD) was calculated as the treatment effect or effect size.
This parameter represents the mean difference standardized
for variances across all studies. To compute SMD for each
study, the mean pre- and postoperative values for each
outcome measure were divided by the standard deviation for
that same outcome measure. Weights were assigned to each
SMD according to the inverse of its variance and then average
was computed. The SMD in each study was pooled with a
fixed- or random-effect model based on heterogeneity.
Inverse variance (I-V) method was used to compute fixed-
effect model, and DerSimonian and Laird (D+L) method was
used to compute random-effects model. To test heterogene-
ity, a Z-value was computed to test the null hypothesis,
which was a treatment effect of zero.
Additionally, heterogeneity was determined using the I2
value, which indicated the extent of variation across studies due
to heterogeneity rather than chance.6 Heterogeneity between
studies was examined using the x2 test, where the x2 test

Fig. 1—Funnel plot of the studies used in the analysis of the Schirmer’s test values, organized by refractive surgeries.

Fig. 2—Funnel plot of the studies used in the analysis of tear break-up time values, organized by refractive surgeries.

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 ARTICLE IN PRESS
Dry eye after refractive surgery: A meta-analysis—Sambhi et al.
assessed whether the observed between-study differences were
due to chance only. Low p-value and a large x2 statistic relative
to its degree of freedom provided evidence of heterogeneity.
Funnel plots were generated to check publication bias.
Publication Bias
The potential presence of publication bias was assessed
with the examination of the funnel plots. Funnel plots for the
Schirmer test and the TBUT for various refractive surgeries
were plotted (Figs. 1 and 2, respectively).
TAGEDH1RESULTSTAGEDEN
Search Results
The search strategy resulted in 3238 studies, which were
potentially relevant to the review; 2335 studies remained after
duplicates were removed. The remaining studies were then
moved to title screening (level 1 screening). After both
reviewers screened the studies, 2068 studies were removed as
they did not explore a link between refractive surgery and dry
eye; 267 of the studies progressed to abstract screening (level
2 screening). At the abstract screening stage, 175 studies were
Fig. 3—PRISMA flow diagram summarizing the screening process.
4 CAN J OPHTHALMOL—VOL. &, NO. &, & 2019
removed because either they did not provide information on
the prevalence of dry eye after refractive surgery or they did
not have abstracts available. After this stage, 92 studies
remained and were moved onto full-text screening (level 3
screening). At the full-text screening stage, the studies were
examined to see if they fulfilled the inclusion criteria, met
any of the exclusion criteria, and had the specific information
and statistics that needed to be extracted. At this stage, the
studies were removed for the following reasons: 7 studies
because they were in a non-English language, 1 study did not
have a large-enough sample size (less than 20 eyes), 8 studies
had the wrong study design, 1 study had the wrong patient
population, 40 studies explored the wrong outcomes, and 11
studies had the wrong intervention. After completing full-
text screening and resolving conflicts, 14 studies remained,
which underwent the quality check process. Two studies
(14.3%) were fair quality; 12 studies (85.7%) were good
quality; no studies were of excellent or poor quality. After
quality check, these studies were moved to the data extraction
stage. The results of the screening process are summarized in
Figure 3. The kappa statistics, which were calculated before
conflict resolution, for levels 1, 2, and 3 of screening were
0.71, 0.42, and 0.94, respectively.
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Dry eye after refractive surgery: A meta-analysis—Sambhi et al.

Study Characteristics change in TBUT values, stratified by refractive surgeries, for

After the screening process, 14 studies remained (published
between 1997 and 2017), which moved onto data extraction
and meta-analysis. Three studies were prospective randomized
comparative studies, 2 were prospective cohort studies, 1 was a
prospective observational study, 4 were retrospective analyses
of case studies, 3 were prospective nonrandomized comparative
studies, and 1 was a prospective nonrandomized observational
study. Two studies explored PRK, 5 studies looked at LASIK,
1 at SMILE, 1 at SMILE and FLEx, 4 at SMILE and LASIK,
and 1 study examined PRK and LASIK. Regarding outcome
measures, 8 studies used Schirmer’s test and TBUT values; 4
studies used Schirmer’s test, TBUT, and a survey score (2 used
OSDI, 1 used the McMonnies Dry Eye Questionnaire, and 1
study used the Salisbury Eye Questionnaire); and 2 studies
used OSDI values. These baseline characteristics are summa-
rized in Appendix D (available online).
Main Outcomes
Impact of refractive surgeries evaluated using tear break -up
time (TBUT). All but one of the studies reported TBUT val-
ues preoperatively and at various follow-up periods (6, 12,
and/or 24 months). Figure 4 presents the postoperative
patients with dry eye. Significant heterogeneity was found
between 5 studies evaluating SMILE (I2 = 95.0%) and 6
studies evaluating LASIK (I2 = 77.1%). After examining the
forest plot for TBUT, the meta-analysis results indicated a
significant increase in TBUT with LASIK (SMD = 0.3;
confidence interval [CI]: 0.53 to 0.08) and FLEX
(SMD = 1.09; CI: 1.44 to 0.74) and a nonsignificant
increase in TBUT with SMILE (SMD = 0.34; CI: 0.95
to 0.27) and PRK (SMD = 0.11; CI: 0.29 to 0.08).
Impact of refractive surgeries evaluated using Schirmer’s test.
All of the studies examined reported Schirmer’s test values
pre-operatively and at various follow-up periods (6, 12, and/
or 24 months). Figure 5 presents the postoperative change in
Schirmer’s test values, stratified by refractive surgeries, for
patients with dry eye. There was significant heterogeneity
between 4 studies examining SMILE (I2 = 79.2%), 2 studies
examining PRK (I2 = 66.2%), and 5 studies evaluating
LASIK (I2 = 76.5%). Our meta-analysis results indicated a
significant increase in tear production with LASIK
(SMD = 0.23; CI: 0.46 to 0.01), and a nonsignificant
increase in tear production with SMILE (SMD = 0.04; CI:
0.28 to 0.36), FLEX (SMD = 0.05; CI: 0.37 to 0.28),
and PRK (SMD = 0.07; CI: 0.32 to 0.19).

Fig. 4—Forest plot depicting the changes in tear break-up time values following the various refractive surgeries (SMILE, FLEX,
PRK, and LASIK).

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 ARTICLE IN PRESS
Dry eye after refractive surgery: A meta-analysis—Sambhi et al.
Fig. 5—Forest plot depicting the changes in Schirmer’s test values following the various refractive surgeries (SMILE, FLEX, PRK,
and LASIK).
Publication Bias
Figure 1 shows the funnel plot of the studies used in the
analysis of the Schirmer’s test values by refractive surgeries.
The studies were scattered from the top to the bottom right of
the plot. Figure 2 shows the funnel plot of the studies used in
the analysis of the TBUT values by refractive surgeries. The
studies were scattered from the top left to the bottom right of
the plot. Therefore, publication bias could not be concluded.
Partially, the reason was difficulty in interpretation of funnel
plot for a small group of studies, high heterogeneity, and small
effect sizes. Additionally, publication bias is only one of the
numerous possible explanations for funnel plot asymmetry.
TAGEDH1DISCUSSIONTAGEDEN
Postoperative dry eye has previously been shown to be
extremely common in patients who undergo refractive surgi-
cal procedures, including LASIK, SMILE, PRK, and FLEx.
Through this study we were able to examine and compare
the rates of dry eye after these procedures. Our meta-analysis
results indicated a significant reduction in TBUT with
LASIK and FLEx, and a nonsignificant reduction in TBUT
with SMILE and PRK. Furthermore, a significant reduction
6 CAN J OPHTHALMOL—VOL. &, NO. &, & 2019
in tear production was observed with LASIK and a nonsignif-
icant reduction in tear production with SMILE, FLEX, and
PRK. A maximum reduction in TBUT as well as a maximum
reduction in tear production was seen with LASIK compared
with other refractive surgeries.
However, there was only one study evaluating FLEX and 2
studies evaluating PRK, and thus more randomized con-
trolled trials are required to make strong conclusions. More-
over, SMILE is a relatively new procedure compared with the
other refractive surgery techniques. Therefore, better quality
randomized controlled trials with large sample sizes and long-
term follow-up data on SMILE are missing.
The increased rates of dry eye in LASIK compared with
the other surgical methods may be explained by damage to
the corneal nerves. In LASIK, when the superior hinge
method is used, both arms of the long posterior corneal
nerves are transected. Using the nasal hinge method in
LASIK, one branch of the long corneal nerve is still trans-
ected.7 For SMILE, literature has shown that fewer corneal
nerve fibres are transected compared with LASIK.8 This
may play a role in preserving corneal sensitivity and may
explain the increased incidence of dry eye in LASIK when
compared with SMILE and other similar refractive
 ARTICLE IN PRESS
Dry eye after refractive surgery: A meta-analysis—Sambhi et al.
surgeries. There was substantial heterogeneity among stud-
ies, and therefore a random-effects model was developed
when required. Several factors likely contributed to the het-
erogeneity, including inconsistency in the differences in the
study population, technical aspects of refractive surgical
techniques, differential peri-operative management, differ-
ences in the study population, potential variability in facili-
ties to perform surgeries, variable follow-up periods, rates of
complications, and year the surgeries were performed.
Limitations are inherent in any systematic review and
meta-analysis due to the variability in the availability of
published data. First, only limited information was available
on pre-operative and postoperative contrast sensitivity,
spherical equivalent, refractive status, stereopsis, and astig-
matism, and thus these parameters were excluded from the
quantitative analysis. Second, meta-analysis of observational
studies is influenced by inherent biases in the included
articles.9,10 For example, there could be other factors such
as income status, socio-economic status, previous ocular
and nonocular surgeries, family history, smoking history,
other ocular and nonocular diseases, pre-operative and post-
operative medications, number of medications, and comor-
bidities such as high blood pressure, diabetes, stroke, and
heart conditions influencing the estimates in the original
studies.1116 Third, some studies were excluded due to lack
of necessary information. Data from these studies could
have influenced the results.
It is also important to note that the incidence of dry eye
may also be attributed to differences in surgical techniques of
the ophthalmologists performing the procedures. Although
there are standardized techniques for each of the refractive
surgeries, minor variability among each of the surgeons could
have affected the incidence of dry eye in study participants.
Finally, a possible bias in the analysis may arise from the
selection of participants in the individual studies. Many of
the studies did not state if all patients presenting to the prac-
tice for refractive surgery were examined for dry eye parame-
ters, or if only symptomatic patients were examined. This can
skew the results as the former group of patients is more repre-
sentative of the general population than the latter group.
Ultimately, systematic reviews and meta-analyses may help
to provide an evidence-based foundation that can be used by
ophthalmologists and patients to guide important decisions
with regard to the best refractive surgery for each particular
situation. More high-quality studies are needed in the future
to reach concrete conclusions.
TAGEDH1SUPPLEMENTARY MATERIALSTAGEDEN
Supplementary material associated with this article can be
found in the online version at doi:10.1016/j.jcjo.2019.07.005.
TAGEDH1REFERENCESTAGEDEN
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care Ophthalmol. 2005;9:1–3.
3. Shtein RM. Post-LASIK dry eye. Expert Rev Ophthalmol. 2012;6:575–82.
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hospital-based population. Indian J Ophthalmol. 2005;53:87.
13. Uchino M, Nishiwaki Y, Michikawa T, et al. Prevalence and risk factors of
dry eye disease in Japan: Koumi study. Ophthalmology. 2011;118:2361–7.
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1994;91:235–9.
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nationwide populationbased study. Acta Ophthalmol. 2012;90:663–8.
Footnotes and Disclosure:
Supported by: This research was funded by the Schulich School of
Medicine and Dentistry—Summer Research Training Program.
Disclosure: The authors have no proprietary or commercial interest
in any materials discussed in this article.
From the *Schulich School of Medicine and Dentistry, Western
University, London, Ont.; yFaculty of Medicine, University of
Ottawa, Ottawa, Ont.; zDepartment of Ophthalmology, Schulich
School of Medicine and Dentistry, Western University, London,
Ont.; xDepartment of Epidemiology and Biostatistics, Schulich
School of Medicine and Dentistry, Western University, London,
Ont.
Originally received Mar. 11, 2019. Final revision Jun. 6, 2019.
Accepted Jul. 12, 2019.
Correspondence to Monali S. Malvankar-Mehta, PhD, Department
of Ophthalmology, Ivey Eye Institute, Western University, St.
Joseph’s Hospital, 268 Grosvenor Street, London, Ont. N6A 4V2.
monali.malvankar@sjhc.london.on.ca
CAN J OPHTHALMOL—VOL. &, NO. &, & 2019 7