E vidence-Based Practice in Critical Care
E
FFECTIVENESS OF
NURSING INTERVENTIONS
TO PREVENT DRY EYE IN
CRITICALLY ILL PATIENTS
By Diego Dias de Araujo, PhD, MSN, RN, Daniel Vinicius Alves Silva, Carolina
Amaral Oliveira Rodrigues, Patricia Oliveira Silva, Tamara Goncalves Rezende
Macieira, BSN, and Tania Couto Machado Chianca, PhD, MSN, RN
©2019 American Association of Critical-Care Nurses
doi:https://doi.org/10.4037/ajcc2019360
www.ajcconline.org
Background Critically ill patients are susceptible to the
development of dry eye. Few studies have been conducted
on how to best prevent and treat this condition.
Objective To compare the effectiveness of 2 nursing interventions in preventing dry eye in adult intensive care unit
patients: liquid artificial tears (Lacribell; Latinofarma)
and artificial tears gel (Vidisic Gel; Bausch and Lomb).
Methods In this randomized controlled trial, 140 participants were randomly assigned to 1 of 2 treatment groups:
a liquid artificial tears group (n = 70) and an artificial tears
gel group (n = 70). The study inclusion criteria were as
follows: admission to the intensive care unit, age of 18
years or older, no diagnosis of dry eye at admission,
receipt of mechanical ventilation, blink rate of less than
5 times per minute, and a score of 7 or less on the
Glasgow Coma Scale. On 5 consecutive days, a single
researcher who was unaware of the treatment assignment assessed the participants’ eyes using the fluorescein eye stain test and the Schirmer test for dry eye.
Results Dry eye developed in 21% of participants who
received liquid artificial tears versus 9% of participants
who received artificial tears gel (P = .04).
Conclusions In this study, artificial tears gel was superior
to liquid artificial tears in preventing the development of
dry eye. These results may help nurses deliver evidencebased eye care aimed at reducing the risk of dry eye in
critically ill patients. (American Journal of Critical Care.
2019;28:299-306)
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I
ntensive care unit (ICU) patients often have conditions leading to compromised physiological mechanisms of eye protection. These conditions include being unconscious or
comatose; taking several medications such as diuretics, sedatives, and `-blockers; receiving mechanical ventilation; and being exposed to air conditioning and low air humidity.1-4 Consequently, these patients are susceptible to the development of dry eye and
other ocular surface disorders.4-7
Clinical guidelines that have been developed for
eye care in the ICU refer to a variety of interventions
designed to reduce the prevalence and incidence of
ocular surface alterations in critically ill patients,
such as corneal ulcerations and keratitis. These interventions include ointments, liquid eyewashes, gels,
moist gauze, paraffin gauze, hydrogel, and polyethylene film.6-8
Dry eye has been defined as a multifactorial
change in tears and the ocular surface that results
in discomfort, visual disturbances, and tear film instability, with potential damage of
the ocular surface.9 In nursing, the diagnosis of “risk for
dry eye” is applied to patients
who are “vulnerable to eye
discomfort or damage to the
cornea and conjunctiva due
to reduced quantity or quality of tears to moisten
the eye, which may compromise health.”10(p387)
A recent study in Brazil showed that dry eye is a
common problem in patients admitted to ICUs, with
an incidence of 53%.5 Intensive care unit patients have
a higher probability of dry eye developing than do
other hospitalized patients because of a variety of
internal and external risk factors.1-3,5 Dry eye can be
chronic and progressive, imposing limitations on
patients’ ability to perform activities of daily living
and negatively affecting their quality of life. Therefore, a preventive approach that includes appropriate eye care is crucial to minimize the risk of dry
eye and avert possible complications.
Fifty-three percent of
adult patients admitted
to intensive care units
have dry eye.
About the Authors
Diego Dias de Araujo is assistant professor and Daniel
Vinicius Alves Silva, Carolina Amaral Oliveira Rodrigues,
and Patricia Oliveira Silva are undergraduate students,
Department of Nursing, Universidade Estadual de Montes
Claros, Montes Claros, Brazil. Tamara Goncalves Rezende
Macieira is a PhD candidate, College of Nursing, University of Florida, Gainesville, Florida. Tania Couto Machado
Chianca is professor, School of Nursing, Universidade
Federal de Minas Gerais, Belo Horizonte, Brazil.
Corresponding author: Diego Dias de Araujo, PhD, MSN, RN,
Av Ruy Braga, Predio 6 (CCBS), Montes Claros, Minas
Gerais, Brazil 39401-089 (email: diego.dias1508@gmail.com).
300
Because nurses are the frontline health care providers in hospitals, they have an important role to
play in reducing the risk of dry eye in critically ill
patients through effective nursing interventions. A
study reported in 2011 compared the effectiveness
of 2 nursing interventions—polyethylene film and
carbomer drops—in the prevention of dry eye among
18 adult ICU patients.2 The polyethylene film was
found to prevent dry eye in all of the cases, while
the carbomer drops were effective in only 17% of
the patients (P < .001).2 However, large studies of
polyethylene film for the prevention of dry eye have
not yet been conducted. Moreover, more research is
needed on evidence-based nursing interventions that
result in less discomfort for patients and can be more
easily applied by nurses than polyethylene film. Therefore, this study was conducted to compare the effectiveness of 2 nursing interventions in preventing dry
eye in adult patients admitted to an ICU: liquid artificial tears (Lacribell; Latinofarma) and artificial tears
gel (Vidisic Gel; Bausch and Lomb).
Methods
This study was registered in ClinicalTrials.gov
(Identifier: NCT02767258) and in the Brazilian
Clinical Trials Registry (ReBec) (Identifier: RBR5r8syp). Ethical approval was obtained from the
institutional review board of the Universidade Federal de Minas Gerais before the study was begun.
We followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines for nonpharmacological interventions.11 Written informed consent
was obtained from each patient’s family member
or next of kin before recruitment.
Design
This was a double-blind (patients, outcome assessor) randomized controlled trial with 2 parallel groups.
The data reported here were collected between January 14, 2016, and March 14, 2017, in a 10-bed ICU
at a large tertiary care, nonprofit hospital in Brazil.
Patients recruited for the study met the following inclusion criteria: age of 18 years or older, no
diagnosis of dry eye at ICU admission, receipt of
mechanical ventilation, blink rate of less than 5
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Inclusion
Assessed for eligibility
(N = 546)
Excluded (n = 406)
• Admitted with the diagnosis of brain death (n = 33)
• Less than 18 years of age (n = 20)
• Diagnosed with dry eye at admission (n = 23)
• Family members did not give consent to patient’s participation in
the study (n = 50)
• Length of stay less than 48 hours (n = 85)
• Patient not receiving mechanical ventilation; blinking 5 or more times
per minute; score higher than 7 on Glasgow Coma Scale (n = 95)
• Failure to locate patient’s next of kin in time to get consent
for patient’s participation and sign the informed consent form
(n = 100)
Randomized
(n = 140)
Allocation
Intervention group, artificial tears gel
(n = 70)
Intervention group, liquid artificial tears
(n = 70)
Evaluation
Loss to follow-up (n = 2)
• Death (n = 1)
• Failure to check if intervention was
performed at the correct time (n = 1)
Loss to follow-up (n = 2)
• Death (n = 1)
• Patient discharged before completing
5 days of evaluation (n = 1)
Analysis
Included in the analysis (n = 70)
Included in the analysis (n = 70)
Figure Flowchart illustrating the 4 phases of the study, following the Consolidated Standards of Reporting Trials
(CONSORT) recommendations for nonpharmacological interventions.
times per minute, and a Glasgow Coma Scale score
of 7 or lower.2 Patients were excluded if they had an
ICU stay of less than 48 hours or were admitted to
the unit with a diagnosis of brain death. Failure to
document the delivery of nursing interventions (liquid artificial tears or artificial tears gel) at the correct
time resulted in the participant’s exclusion from the
study and discontinuation of treatment.
Sample Size and Randomization
We performed a pilot study involving 30 patients
between November and December 2015, with 10
patients allocated to each of 3 groups (liquid artificial tears, artificial tears gel, and 0.9% sodium chloride solution), to estimate sample size. In the pilot
study, 40% of the patients treated with liquid artificial tears had dry eye develop, compared with 10%
of those treated with artificial tears gel (P = .01).
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Power analysis using the proportion of unfavorable
results in the pilot study (40%), a significance level
of .05, power of 80%, and a relative risk (RR) of 0.5
in favor of artificial tears gel (or RR reduction of 20%)
resulted in an estimated sample size of 134 patients:
67 patients for each of the 2 intervention groups. If
any participants were lost during the study, more
would be recruited until at least 67 patients were
allocated to each group.
The initial study population consisted of 546
medical or surgical patients who had been admitted
to the ICU of the target hospital. Of the 546 patients
assessed for eligibility, 406 were excluded according
to the inclusion and exclusion criteria. The resulting
final sample consisted of 140 patients, 70 in each
group (see Figure).
Despite allocation to a third group in the pilot
study, we decided not to treat patients with 0.9%
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301
sodium chloride solution in this study. The results
of the pilot study showed that 60% of patients allocated to this intervention group had dry eye develop.
The findings of previous studies support our decision not to use 0.9% sodium chloride solution as a
study intervention.1,12
A statistician performed block randomization
of patients using the computer software R-3.2.3.
The randomized
list was subdivided every 10
patients into 2
groups in a 1:1
ratio. The list
was sent directly
to the research
coordinator of
the study (T.C.M.C.) and to 2 undergraduate research
assistants (D.V.A.S., C.A.O.R.) who were responsible
for the allocation of the patients.
Two lubricant eye drops were
used as interventions: liquid
artificial tears (Lacribell) and
artificial tears gel (Visidic Gel).
Interventions
Two types of lubricating eye drops—liquid artificial tears (Lacribell) and artificial tears gel (Vidisic
Gel)—were used as the study interventions. After a
patient was recruited for the study, the ICU nurses
were notified through an information center which
of the 2 interventions would be used for that patient.
The intervention was prepared by a nurse and stored
in a brown envelope. The ICU’s nursing technicians
delivered the intervention twice a day (at 8:00 AM and
8:00 PM) for 5 consecutive days. The nursing technicians followed a protocol for cleaning the patient’s
eyes with 0.9% sodium chloride before administering 2 drops of the predetermined intervention to
each eye.
Before the study was begun, we trained the nursing team in the study protocols and procedures. The
training consisted of an explanation of the study
problem; an overview of the study methods; description of the inclusion and exclusion criteria; instruction on when to
discontinue the
interventions;
explanation of
informed consent,
its importance, and
how to obtain it;
and the techniques for application of each intervention. To increase the chances of recruiting participants, nurses were given the responsibility for
obtaining informed consent because of the study
personnel’s inability to be present on the unit for
24 consecutive hours.
The ocular assessment consisted of the Schirmer test
and the fluorescein test.
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Outcome
The study outcome was the development of dry
eye. Potentially confounding variables included in the
data analysis were age, sex, unit of origin, Nursing
Activities Score, Acute Physiology and Chronic Health
Evaluation II score; patient type (medical condition
only or postsurgical), death, length of stay, referral
unit, medical diagnosis at admission, sedation, Ramsay Sedation Scale score, Glasgow Coma Scale score,
intubation, tracheostomy, mechanical ventilation, days
of mechanical ventilation, mode of mechanical ventilation, fraction of inspired oxygen, positive endexpiratory pressure, other ventilatory assistance device,
blink rate per minute, ocular surface exposure, edema,
severity of corneal ulcer, medications, and positioning (degree of head elevation).
Data Collection
On 5 consecutive days, one of the researchers
(D.D.A.) collected data and performed ocular assessment for each participant included in the sample.
This 5-day period was established on the basis of the
reported mean time of 3.5 days for development of
dry eye in critically ill patients.5 Before ocular assessment, the nursing technicians cleaned the patient’s
eyes with 0.9% sodium chloride solution to remove
any traces of the intervention substances, ensuring
that the researcher remained unaware of the treatment allocation of each patient.
The ocular assessment consisted of the Schirmer
test and the fluorescein eye stain test. The Schirmer test
was used to analyze tear volume. This test involved
placing a strip of Whatman filter paper grade 41 or
50 measuring 5 mm wide and 35 mm long with the
tip folded (about 5 mm) in the bottom of the lower
conjunctival sac in the temporal region (outer corner of the lower eyelid). After 5 minutes, the strip
was removed and the moistened part was measured
and the result documented.13 The fluorescein eye stain
test was used to evaluate the cornea for possible abnormalities. A drop of fluorescein was placed in each of
the patient’s eyes; after 1 to 2 minutes, under low-light
conditions, the cornea was examined using an ophthalmoscope with a cobalt blue light filter and a
magnifying glass.13
Data Analysis
Two of the researchers (C.A.O.R., P.O.S.) independently entered the data into the Epi Info software program, version 3.5.1. The data entered were
checked for consistency and then extracted and analyzed in the R-3.2.3 software. Frequency, central
tendency (average), and standard deviation were
measured. Categorical variables in the 2 intervention
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Table 1
Risk scores, demographic variables, and baseline comorbidities by group
Variable
Continuous
Age, y
APACHE II score
Score on Ramsay Sedation Scale
Score on Glasgow Coma Scale
Schirmer test result, mm
Liquid artificial tears
Artificial tears gel
Pa
52.8 (19.9) (n = 70)
21.5 (7.6) (n = 70)
5.9 (0.3) (n = 63)
0 (0) (n = 7)
12.9 (3.7) (n = 70)
.98
.94
.24
.49
.19
Mean (SD)
52.8 (19.8) (n = 70)
22.2 (8.9) (n = 70)
5.9 (0.3) (n = 59)
0.1 (0.3) (n = 11)
13.6 (3.9) (n = 70)
No. (%) of 70 patients in each group
Categorical
Female sex
Heart disease
Vascular disease
Neurologic disease
Pneumonia
Trauma
Gastric disease
Metabolic disease
Neoplasm
Patient sedated
30
0
12
5
3
22
3
2
1
60
(43)
(0)
(17)
(7)
(4)
(31)
(4)
(3)
(1)
(86)
24 (34)
4 (6)
13 (19)
9 (13)
4 (6)
16 (23)
9 (13)
2 (3)
5 (7)
63 (90)
.38
.12
> .99
.40
> .99
.34
.13
> .99
.21
.61
Abbreviation: APACHE II, Acute Physiology and Chronic Health Evaluation II.
a
Mann-Whitney test was used to compare continuous variables; Fisher exact test was used to compare categorical variables. For both tests, P ) .05 was
considered significant.
groups were compared using the Fisher exact test.
Continuous variables were compared using the
Mann-Whitney test. The assumption that the distribution of the continuous variables was normal was
tested using the Shapiro-Wilk test. The incidence of
dry eye and the effect of the nursing interventions
were analyzed using the Fisher exact test. The results
were presented with a 95% CI. Poisson regression was
used to present the results, with the model adjusted
for potential confounders (the risk factors of age,
sex, and ocular surface exposure). Statistical significance was set at P ≤ .05.
Results
Participants
In total, 140 patients were included and randomized in the study. No statistically significant
differences were found between the 2 groups at
baseline (P ≤ .05; Tables 1 and 2), confirming that
randomization was sufficient to match the groups.
The fluorescein eye test indicated the presence of
corneal ulceration in 1 participant treated with liquid artificial tears and 2 participants treated with
artificial tears gel (Table 2; P > .99).
Development of Dry Eye
Table 3 shows the incidence of the primary outcome (dry eye) during the 5-day evaluation period.
On the fifth day of hospitalization, dry eye was present in 21% of patients (incidence rate of 4.28 per
100 patient-days) in the liquid artificial tears group
and 9% of patients (incidence rate of 1.72 per 100
patient-days) in the artificial tears gel group.
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The RR estimated for the effect of the intervention was 0.400 (95% CI, 0.166-0.964; P = .04; Table
4), indicating that the chance of dry eye developing
was twice as high
in the liquid artificial tears group
as in the artificial
tears gel group.
The effect of the
artificial tears gel
intervention
remained statistically significant
(P = .04) after
model adjustment for the risk factors (age, sex, and ocular surface
exposure) identified in the sample (Table 4).
The nursing team should identify risk factors for dry eye as
soon as a patient is admitted
to the ICU and then implement
the needed interventions,
such as artificial tears gel.
Discussion
Most studies conducted to date on eye care practices for hospitalized patients focus on the prevention
of corneal ulcers and associated risk factors. Little
attention has been given to the problem of dry eye,
especially among patients admitted to ICUs. Yet
dry eye, if not adequately treated, can lead to corneal ulcers.9,13
Our results showed that artificial tears gel is more
effective than liquid artificial tears (RR = 0.400; 95%
CI, 0.166-0.964; P = .04) in preventing dry eye in
adult ICU patients. We found no other published
studies comparing these 2 interventions. Ezra et al14
compared artificial tears gel and hydrogel in the prevention of exposure keratopathy among critically ill
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Table 2
Characteristics of hospitalization, baseline
lesions, and use of medications by group
No. (%) of 70 patients
in each group
Liquid
artificial
tears
Characteristic
Unit of origin
Emergency unit
Emergency department
Medical unit
Other institution
Surgical unit
10
1
17
3
39
Patient type, surgical
42 (60)
Pa
.25
Ocular surface exposure
(14)
(1)
(24)
(4)
(56)
19
3
14
1
33
(27)
(4)
(20)
(1)
(47)
33 (47)
.18
7 (10)
.76
5 (7)
Type of lesion (corneal ulcer)
1 (1)
2 (3)
Analgesic
42 (60)
45 (64)
.73
Antibiotic
48 (69)
51 (73)
.71
Anticoagulant
34 (49)
25 (36)
.17
Antiepileptic
14 (20)
21 (30)
4 (6)
4 (6)
> .99
Antiemetic
18 (26)
17 (24)
> .99
Antihypertensive
14 (20)
10 (14)
.50
Antiprotozoal
1 (1)
3 (4)
.62
Bronchodilator
5 (7)
7 (10)
.76
Corticosteroid
10 (14)
7 (10)
.61
Diuretic
26 (37)
29 (41)
.73
Vasodilator
50 (71)
53 (76)
.70
Hypnotics
58 (83)
63 (90)
.32
Hypolipid
8 (11)
3 (4)
.21
Hormone
1 (1)
1 (1)
> .99
Gastric bypass inhibitor
57 (81)
59 (84)
.82
Insulin
30 (43)
26 (37)
.60
Antihelminthic
a
Artificial
tears
gel
> .99
.24
Fisher exact test was used to compare variables. P ) .05 was considered significant.
Table 3
Incidence of dry eye during 5-day
evaluation period by group
No. (%) of cases of dry eye
Hospital day
2
3
4
5
a
Liquid artificial tears
1/70
2/69
4/68
15/70
(1)
(3)
(6)
(21)
Artificial tears gel
2/70
5/68
5/68
6/70
(3)
(7)
(7)
(9)
Pa
> .99
.27
> .99
.04
Fisher exact test was used to compare groups. P ) .05 was considered significant.
patients. They found that exposure keratopathy
developed in 15% of patients in the artificial tears
gel group, compared with 90% of patients treated
304
with hydrogel (P = .04). In Brazil, hydrogel is approved
as a dressing for the treatment of lesions or cutaneous wounds, but it has not been approved for use
in ophthalmology.
Zhou et al15 conducted a meta-analysis on the
prevention of corneal alterations among critically
ill patients; they found no statistically significant
differences in effectiveness between moisture chambers and lubricating gel (RR = 0.81; 95% CI, 0.511.29; P = .38). The authors also examined studies
that tested polyethylene film versus lubricating eye
drops, but those studies were of lower quality.15 In
other studies,16-18 polyethylene film was more effective in preventing corneal ulcers than liquid artificial tears and ocular gel, although the differences
were not statistically significant.
The incidence of dry eye during the 5-day evaluation period in our study was from 1% to 21% in
the liquid artificial tears group and from 3% to 9%
in the artificial tears gel group. The development of
dry eye was assessed for a relatively short time. However, this assessment period is supported by a study
conducted in Brazil,5 where researchers found a mean
time of 3.5 days for the development of dry eye among
the same target population. Although the patients
were exposed to internal and external risk factors
related to a decrease in production of tears or an
increase in their evaporation, the present study
showed that after the fourth day of hospitalization,
the artificial tears gel intervention was more likely
than the liquid artificial tears intervention to prevent dry eye.
The use of block randomization for allocation
of participants to either the artificial tears gel group
or the liquid artificial tears group ensured an even
distribution of participants between the groups
within the established data collection time frame.
This type of randomization is preferred over individual patient randomization to avoid the risk of
having a smaller number of participants in one of
the study groups in the event of premature completion of data collection due to unforeseen reasons.
Because nursing professionals provide uninterrupted care to patients admitted to ICUs, they are
well positioned to help reduce the risk of dry eye
in these patients through appropriate eye care practices. Dry eye is a precursor to more serious eye changes
that can result in severe harm to patients. Therefore,
the nursing team must be knowledgeable about this
condition and follow eye care practices designed to
prevent or minimize damage to the ocular surface
and resulting visual impairment. Once a patient is
admitted to the ICU, the nursing team should assess
the patient’s ocular surface and identify possible risk
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Table 4
Regression model adjusted for age, sex, and ocular surface exposure
Intervention
Incidence, %
Relative risk
Unadjusted
Liquid artificial tears
Artificial tears gel
21.4
8.6
1.000
0.400
Adjusted for age and sex
Liquid artificial tears
Artificial tears gel
21.4
8.6
1.000
0.418
Adjusted for age, sex, and ocular surface exposure
Liquid artificial tears
Artificial tears gel
21.4
8.6
1.000
0.367
P
.04
0.166-0.964
.07
factors for dry eye, implementing necessary interventions such as artificial tears gel as early as possible.
Liquid artificial tears or artificial tears gel cannot
directly prevent the evaporation of tear film in patients
with lagophthalmos. However, in the present study
we observed that the artificial tears gel could keep
the upper and lower eyelids adhered, in addition to
forming a thin film in the palpebral space, increasing
its retention time on the ocular surface. This mechanism might facilitate lid closure and thus help
prevent complications. Nonetheless, polyethylene
film is the preferred intervention to prevent corneal
ulceration in patients with lagophthalmos. In covering the eye area, it creates a moisture chamber that
prevents evaporation of tears.2,14,16,19 If corneal ulceration is identified during ocular assessment, an ophthalmologist should be consulted.
This study has a few limitations, which may
have affected the findings. The sample consisted
only of patients admitted to an ICU, and the interventions were delivered twice a day (to suit the
study site routine), whereas it is generally recommended to administer treatment whenever necessary. We did not test polyethylene film or other
interventions that have been described in clinical
guidelines developed to prevent eye diseases. Moreover, although it is unlikely, it is possible that the
protocol of cleaning the patient’s eyes with 0.9%
sodium chloride solution did not completely remove
all traces of the intervention substances applied.
In this study, patients with a Glasgow Coma
Scale score of 7 or lower were under sedation for 5
days, which may not accurately represent sedation
practices outside of Brazil or other developing countries. Future studies on prevention of dry eye should
recruit a sample that is representative of the range of
sedation practices. The protocols used for application of the interventions and ocular assessment for
the development of dry eye were designed to enhance
the rigor of the study and may not be applicable in
clinical practice. However, the artificial tears gel intervention can be delivered by nurses on schedules
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95% CI
0.163-1.070
.04
0.140-0.963
different from the one in this study, including its use
as a preventive measure at intervals of up to 12 hours.
Conclusion
This study showed that artificial tears gel is more
effective than liquid artificial tears in the prevention
of dry eye in critically ill patients. It is paramount that
nurses identify possible risk factors for dry eye when
performing a physical examination or
reviewing a patient’s
medical record. In
addition, nurses
should implement
early interventions
that can prevent or minimize dry eye as well as complications of this condition that may negatively affect
the patient’s life. Teaching health professionals how
to perform an ocular assessment is an essential measure in the prevention of dry eye in patients admitted to the ICU.
Artificial tears gel is more
effective than liquid artificial
tears for preventing dry eye.
ACKNOWLEDGMENTS
This work was performed at the Universidade Estadual
de Montes Claros, Montes Claros, Brazil.
FINANCIAL DISCLOSURES
This research was supported by the National Council for
Scientific and Technological Development, Brazil (grant
number 441971/2014-8). The contents of this article are
the sole responsibility of the authors and do not necessarily represent the official views of the Council.
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