Viscotears liquid gel bausch and lomb

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Evidence-Based Practice in Critical Care

©2019 American Association of Critical-Care Nurses doi:https://doi.org/10.4037/ajcc2019360

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 inter- ventions 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 partici- pants 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 assign- ment assessed the participants’ eyes using the fluores- cein 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 evidence- based eye care aimed at reducing the risk of dry eye in critically ill patients. (American Journal of Critical Care. 2019;28:299-306)

EFFECTIVENESS 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

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I ntensive care unit (ICU) patients often have conditions leading to compromised physio- logical mechanisms of eye protection. These conditions include being unconscious or comatose; taking several medications such as diuretics, sedatives, and -blockers; receiv- ing mechanical ventilation; and being exposed to air conditioning and low air humid- ity.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 inter- ventions include ointments, liquid eyewashes, gels, moist gauze, paraffin gauze, hydrogel, and polyeth- ylene film.6-8

Dry eye has been defined as a multifactorial change in tears and the ocular surface that results

in discomfort, visual distur- bances, and tear film instabil- ity, with potential damage of the ocular surface.9 In nurs- ing, 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. There- fore, a preventive approach that includes appropri- ate eye care is crucial to minimize the risk of dry eye and avert possible complications.

Because nurses are the frontline health care pro- viders 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. There- fore, this study was conducted to compare the effec- tiveness of 2 nursing interventions in preventing dry eye in adult patients admitted to an ICU: liquid arti- ficial 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: RBR- 5r8syp). Ethical approval was obtained from the institutional review board of the Universidade Fed- eral de Minas Gerais before the study was begun. We followed the Consolidated Standards of Report- ing Trials (CONSORT) guidelines for nonpharmaco- logical 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 asses-

sor) randomized controlled trial with 2 parallel groups. The data reported here were collected between Janu- ary 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 follow- ing 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

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, Univer- sity 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).

Fifty-three percent of adult patients admitted to intensive care units

have dry eye.

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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 (liq- uid 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 artifi- cial tears, artificial tears gel, and 0.9% sodium chlo- ride solution), to estimate sample size. In the pilot study, 40% of the patients treated with liquid artifi- cial tears had dry eye develop, compared with 10% of those treated with artificial tears gel (P = .01).

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%

Figure Flowchart illustrating the 4 phases of the study, following the Consolidated Standards of Reporting Trials (CONSORT) recommendations for nonpharmacological interventions.

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)

Inclusion

Intervention group, artificial tears gel (n = 70)

Included in the analysis (n = 70) Included in the analysis (n = 70)

Intervention group, liquid artificial tears (n = 70)

Allocation

Analysis

Randomized (n = 140)

Assessed for eligibility (N = 546)

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)

Evaluation

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sodium chloride solution in this study. The results of the pilot study showed that 60% of patients allo- cated to this intervention group had dry eye develop. The findings of previous studies support our deci- sion 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 subdi- vided 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.

Interventions Two types of lubricating eye drops—liquid arti-

ficial 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 techni- cians followed a protocol for cleaning the patient’s eyes with 0.9% sodium chloride before administer- ing 2 drops of the predetermined intervention to each eye.

Before the study was begun, we trained the nurs- ing team in the study protocols and procedures. The training consisted of an explanation of the study problem; an overview of the study methods; descrip- tion of the inclusion and exclusion criteria; instruc-

tion on when to discontinue the interventions; explanation of informed consent, its importance, and how to obtain it;

and the techniques for application of each inter- vention. To increase the chances of recruiting par- ticipants, 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.

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, Ram- say Sedation Scale score, Glasgow Coma Scale score, intubation, tracheostomy, mechanical ventilation, days of mechanical ventilation, mode of mechanical ven- tilation, fraction of inspired oxygen, positive end- expiratory pressure, other ventilatory assistance device, blink rate per minute, ocular surface exposure, edema, severity of corneal ulcer, medications, and position- ing (degree of head elevation).

Data Collection On 5 consecutive days, one of the researchers

(D.D.A.) collected data and performed ocular assess- ment 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 assess- ment, 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 treat- ment 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 cor- ner 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 abnor- malities. 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 oph- thalmoscope with a cobalt blue light filter and a magnifying glass.13

Data Analysis Two of the researchers (C.A.O.R., P.O.S.) inde-

pendently entered the data into the Epi Info soft- ware program, version 3.5.1. The data entered were checked for consistency and then extracted and ana- lyzed in the R-3.2.3 software. Frequency, central tendency (average), and standard deviation were measured. Categorical variables in the 2 intervention

The ocular assessment con- sisted of the Schirmer test

and the fluorescein test.

Two lubricant eye drops were used as interventions: liquid

artificial tears (Lacribell) and artificial tears gel (Visidic Gel).

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The nursing team should iden- tify 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.

groups were compared using the Fisher exact test. Continuous variables were compared using the Mann-Whitney test. The assumption that the distri- bution 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 signifi- cance was set at P ≤ .05.

Results Participants

In total, 140 patients were included and ran- domized 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 liq- uid 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 out-

come (dry eye) during the 5-day evaluation period. On the fifth day of hospitalization, dry eye was pres- ent 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.

The RR estimated for the effect of the interven- tion 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 arti- ficial tears group as in the artificial tears gel group. The effect of the artificial tears gel intervention remained statisti- cally significant (P = .04) after model adjust- ment for the risk factors (age, sex, and ocular surface exposure) identified in the sample (Table 4).

Discussion Most studies conducted to date on eye care prac-

tices 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 cor- neal 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 pre- vention of exposure keratopathy among critically ill

Table 1 Risk scores, demographic variables, and baseline comorbidities by group

Continuous Age, y APACHE II score Score on Ramsay Sedation Scale Score on Glasgow Coma Scale Schirmer test result, mm

Categorical Female sex Heart disease Vascular disease Neurologic disease Pneumonia Trauma Gastric disease Metabolic disease Neoplasm Patient sedated

.98 .94 .24 .49 .19

.38 .12 > .99 .40 > .99 .34 .13 > .99 .21 .61

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)

24 (34) 4 (6)

13 (19) 9 (13)

4 (6) 16 (23) 9 (13)

2 (3) 5 (7)

63 (90)

No. (%) of 70 patients in each group

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)

30 (43) 0 (0)

12 (17) 5 (7) 3 (4)

22 (31) 3 (4) 2 (3) 1 (1)

60 (86)

Variable Liquid artificial tears Artificial tears gel P a

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.

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patients. They found that exposure keratopathy developed in 15% of patients in the artificial tears gel group, compared with 90% of patients treated

with hydrogel (P = .04). In Brazil, hydrogel is approved as a dressing for the treatment of lesions or cutane- ous 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 cham- bers and lubricating gel (RR = 0.81; 95% CI, 0.51- 1.29; 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 effec- tive in preventing corneal ulcers than liquid artifi- cial tears and ocular gel, although the differences were not statistically significant.

The incidence of dry eye during the 5-day evalu- ation 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. How- ever, 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 pre- vent 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 indi- vidual patient randomization to avoid the risk of having a smaller number of participants in one of the study groups in the event of premature comple- tion of data collection due to unforeseen reasons.

Because nursing professionals provide uninter- rupted 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 prac- tices. 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

Table 2Characteristics of hospitalization, baseline lesions, and use of medications by group

Unit of origin Emergency unit Emergency department Medical unit Other institution Surgical unit

Patient type, surgical

Ocular surface exposure

Type of lesion (corneal ulcer)

Analgesic

Antibiotic

Anticoagulant

Antiepileptic

Antihelminthic

Antiemetic

Antihypertensive

Antiprotozoal

Bronchodilator

Corticosteroid

Diuretic

Vasodilator

Hypnotics

Hypolipid

Hormone

Gastric bypass inhibitor

Insulin

10 (14) 1 (1)

17 (24) 3 (4)

39 (56)

42 (60)

5 (7)

1 (1)

42 (60)

48 (69)

34 (49)

14 (20)

4 (6)

18 (26)

14 (20)

1 (1)

5 (7)

10 (14)

26 (37)

50 (71)

58 (83)

8 (11)

1 (1)

57 (81)

30 (43)

19 (27) 3 (4)

14 (20) 1 (1)

33 (47)

33 (47)

7 (10)

2 (3)

45 (64)

51 (73)

25 (36)

21 (30)

4 (6)

17 (24)

10 (14)

3 (4)

7 (10)

7 (10)

29 (41)

53 (76)

63 (90)

3 (4)

1 (1)

59 (84)

26 (37)

.25

.18

.76

> .99

.73

.71

.17

.24

> .99

> .99

.50

.62

.76

.61

.73

.70

.32

.21

> .99

.82

.60

Characteristic P a

Artificial tears gel

No. (%) of 70 patients in each group

Liquid artificial

tears

a 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

2 3 4 5

1/70 (1) 2/69 (3) 4/68 (6)

15/70 (21)

2/70 (3) 5/68 (7) 5/68 (7) 6/70 (9)

> .99 .27 > .99 .04

a Fisher exact test was used to compare groups. P .05 was considered significant.

Hospital day Artificial tears gel

No. (%) of cases of dry eye

Liquid artificial tears P a

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Intervention

Table 4 Regression model adjusted for age, sex, and ocular surface exposure

Unadjusted Liquid artificial tears Artificial tears gel

Adjusted for age and sex Liquid artificial tears Artificial tears gel

Adjusted for age, sex, and ocular surface exposure Liquid artificial tears Artificial tears gel

.04

.07

.04

0.166-0.964

0.163-1.070

0.140-0.963

1.000 0.400

1.000 0.418

1.000 0.367

21.4 8.6

21.4 8.6

21.4 8.6

P 95% CIRelative riskIncidence, %

factors for dry eye, implementing necessary interven- tions 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 mech- anism 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 cover- ing the eye area, it creates a moisture chamber that prevents evaporation of tears.2,14,16,19 If corneal ulcer- ation is identified during ocular assessment, an oph- thalmologist 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 inter- ventions were delivered twice a day (to suit the study site routine), whereas it is generally recom- mended to administer treatment whenever neces- sary. We did not test polyethylene film or other interventions that have been described in clinical guidelines developed to prevent eye diseases. More- over, 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 coun- tries. Future studies on prevention of dry eye should recruit a sample that is representative of the range of sedation practices. The protocols used for applica- tion 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 inter- vention can be delivered by nurses on schedules

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 physi- cal 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 com- plications of this condition that may negatively affect the patient’s life. Teaching health professionals how to perform an ocular assessment is an essential mea- sure in the prevention of dry eye in patients admit- ted to the ICU.

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 neces- sarily represent the official views of the Council.

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