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Sci Rep
Sci Rep
Scientific Reports
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Nature Publishing Group UK London

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10.1038/s41598-024-71601-1
Article
Lubratex eye ointment with polyethylene cover significantly reduces corneal abrasion in ICU patients: a randomized controlled trial
Nikseresht Tahere 1
Rezaei Mansour 2
Sharifian Elahe 2
http://orcid.org/0000-0003-3552-5539
Khatony Alireza Akhatony@gmail.com
Akhatony@kums.ac.ir

23
1 https://ror.org/05vspf741 grid.412112.5 0000 0001 2012 5829 Student Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran
2 https://ror.org/05vspf741 grid.412112.5 0000 0001 2012 5829 Social Development and Health Promotion Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
3 https://ror.org/05vspf741 grid.412112.5 0000 0001 2012 5829 Infectious Diseases Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
3 9 2024
3 9 2024
2024
14 2044311 4 2024
29 8 2024
© The Author(s) 2024
2024
https://creativecommons.org/licenses/by-nc-nd/4.0/ Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.
Corneal abrasion is a frequent complication in critically ill, intubated patients, potentially leading to visual impairment. This study compares the efficacy of three ocular care methods in preventing corneal abrasion among this vulnerable population. We conducted a randomized controlled trial involving 156 intubated adult patients admitted to the ICU. Participants were randomly allocated to one of three intervention groups (n = 52 per group): (1) polyethylene cover only, (2) polyethylene cover with artificial tear drops, and (3) polyethylene cover with Lubratex eye ointment. One eye per patient was randomly assigned as the control, receiving standard ICU eye care. Daily assessments over five days included a standardized dryness and corneal abrasion checklist, graded strip evaluation of eye dryness, and documentation of corneal abrasion incidence. Data were analyzed using descriptive and inferential statistics (SPSS-18). The incidence of corneal abrasion was significantly lower in the group receiving polyethylene cover with Lubratex eye ointment (4%) compared to the polyethylene cover with artificial tears group (36%, p < 0.001) and the polyethylene cover only group (60%, p < 0.001). The combined application of a polyethylene cover with Lubratex eye ointment effectively prevents corneal abrasion in intubated ICU patients. This method demonstrates superior efficacy compared to polyethylene covers used alone or with artificial tears. We recommend its implementation as standard practice for corneal abrasion prophylaxis in this high-risk population.

Trial Registration. This study is registered with the Iranian Registry of Clinical Trials (IRCT201506294736N8) and can be accessed at www.IRCT.ir.

Subject terms

Diseases
Health care
Medical research
Risk factors
Deputy for Research and Technology, Kermanshah University of Medical Sciences95454 95454 95454 95454 Nikseresht Tahere Rezaei Mansour Sharifian Elahe Khatony Alireza issue-copyright-statement© Springer Nature Limited 2024
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pmcIntroduction

Critically ill patients often require life-saving interventions that inadvertently increase their risk of ocular surface complications1–4. Sedation, mechanical ventilation, and the use of certain medications can disrupt normal tear production and eyelid function, leaving the cornea vulnerable to injury5–9. Among these complications, corneal abrasion presents a significant concern, potentially leading to scarring, vision impairment, and prolonged hospital stays10–13.

While the reported prevalence of corneal abrasion in intensive care unit (ICU) patients varies11,14, its impact underscores the need for effective preventative measures. Numerous studies have investigated various ocular care strategies, including polyethylene films, artificial tear drops, ointments, and eyelid taping5–8,15–17. However, these trials have yielded inconsistent findings, leaving clinicians without a clear consensus on the optimal approach. Some studies favor polyethylene covers over other methods8, while others report comparable efficacy among different interventions17.

This lack of standardization, coupled with the significant morbidity associated with corneal abrasion, necessitates further investigation into the most effective preventative strategies for this vulnerable patient population. This randomized controlled trial aims to directly compare three commonly used methods for corneal protection in intubated ICU patients: (1) polyethylene cover alone, (2) polyethylene cover with artificial tear drops, and (3) polyethylene cover with Lubratex eye ointment.

Specifically, this study addresses the following questions:1. What is the progression of corneal abrasion severity from day one to day five in each intervention group?

2. How effective are the three methods in preventing the incidence of corneal abrasion over the five-day study period?

3. Which of the three methods demonstrates the highest efficacy in preventing corneal abrasion?

Materials and methods

Study design

This prospective, parallel-group, randomized controlled trial employed a 1:1:1 allocation ratio to compare the efficacy of three corneal protection methods in preventing abrasion. The study adhered to the consolidated standards of reporting trials (CONSORT) guidelines1 (Fig. 1).Fig. 1 The CONSORT diagram of the study.

Study hypothesis

We hypothesized that the incidence of corneal abrasion would differ significantly among the three intervention groups: (1) polyethylene cover alone, (2) polyethylene cover with artificial tear drops, and (3) polyethylene cover with Lubratex eye ointment.

Participants and setting

This study included 156 adult patients (≥ 18 years old) admitted to the intensive care units (ICUs) of Imam Khomeini and Mostafa Khomeini hospitals in Ilam, western Iran. These hospitals have a combined total of 24 ICU beds.

Sample size and randomization

The sample size was calculated based on previous studies by Cortese et al.19 and Koroloff et al.20, aiming for a confidence level of 95% and a power of 80%2,3. Using a simple random sampling method, participants were allocated to one of the three intervention groups using a computer-generated random number table. One eye of each participant was randomly designated as the “intervention eye,” while the other served as the “control eye.” The allocation process was performed by the first author.

Blinding

A single-blind approach was implemented, with the statistician blinded to the group assignments throughout data analysis.

Inclusion and exclusion criteria

The inclusion criteria were: age ≥ 18 years, glasgow coma scale (GCS) score ≤ 8, use of neuromuscular blockers and sedative medications, intubation, negative Schirmer and fluorescein test results, no history of ocular diseases, anticipated ICU stay longer than 24 h, and informed consent obtained from the patient’s legal representative. The exclusion criteria included: ICU discharge, improved consciousness level (GCS > 8), extubation, return of spontaneous blink reflex, and patient mortality.

Data collection and instruments

Data were collected using a combination of standardized instruments and clinical assessments, as detailed below:

A structured form was used to collect patient demographic information (age, sex), clinical characteristics (primary diagnosis, GCS score, duration of ICU stay), medication use (sedatives, analgesics, neuromuscular blockers), and baseline ocular assessment results (Schirmer test, fluorescein staining).

Eyelid closure was assessed using the six-point lagophthalmos intensity checklist2, ranging from 0 to 5 as follows: 0: Complete eyelid closure, 1: Conjunctiva exposed, 2: One-quarter of the lower cornea exposed, 3: One-half of the cornea exposed, 4: Three-quarters of the cornea exposed, and 5: Complete corneal exposure.

Corneal abrasion was assessed daily by a trained clinician using a handheld slit lamp (HSL150, Germany) and fluorescein staining (Elham Tab, Iran). The presence or absence of corneal abrasion was documented for both the intervention and control eyes.

Intervention materials

The following materials were used for the three intervention groups:Polyethylene cover: Sterile, disposable polyethylene eye covers (Pars Atlas Company, Iran) were used to provide a protective barrier for the cornea. Polyethylene is a versatile, moisture-resistant plastic commonly used in medical settings11,21.

Artificial tear drops: Tearlose artificial tear drops (containing hydroxypropyl methylcellulose) were used to supplement natural tear production8.

Lubratex eye ointment: Lubratex sterile ophthalmic ointment (Sina Darou Company, Iran) was used to provide lubrication and prevent corneal drying.

Eye dryness measurement: Sterile SM TUBE strips (Japan) were used to assess tear film stability and evaluate eye dryness.

Interventions

This study was conducted as part of a larger research project for the first author’s thesis. Before enrollment, all patients underwent a comprehensive ophthalmic examination to confirm the absence of pre-existing corneal abrasion or significant dry eye. This baseline assessment included:Schirmer test: Tear production was evaluated using the Schirmer test, with a result of 5 mm or more of wetting on the graded strip considered normal.

Fluorescein staining: The ocular surface was stained with fluorescein, and the cornea was examined using a handheld slit lamp to rule out any pre-existing abrasions.

Lagophthalmos assessment: The degree of lagophthalmos (incomplete eyelid closure) was assessed using the six-point Lagophthalmos Intensity Checklist.

Patients without evidence of corneal abrasion or significant dry eye were then randomly assigned to one of three intervention groups (n = 52 per group):Polyethylene cover group: A sterile, transparent polyethylene eye cover was applied to the intervention eye, secured with hypoallergenic tape extending from above the eyebrow to the cheekbone. The cover was replaced daily or sooner if soiled, damaged, or dislodged.

Polyethylene cover with artificial tears group: In addition to the polyethylene cover, one drop of Tearlose artificial tears was instilled into the intervention eye every eight hours.

Polyethylene cover with Lubratex eye ointment group: Along with the polyethylene cover, a small amount of Lubratex sterile ophthalmic ointment was applied to the lower eyelid margin of the intervention eye every eight hours.

Control group and study duration

The control eye in each participant received standard ICU eye care every eight hours, consisting of gentle cleaning of the eyelids, eyelashes, and surrounding skin with sterile distilled water and gauze. All interventions and assessments were conducted for five consecutive days. Daily examinations by the ophthalmologist were performed to assess for corneal abrasion and document any adverse events, using standardized data collection forms22.

Statistical analysis

Data were analyzed using SPSS software, version 18 (IBM Corp., Armonk, NY). Descriptive statistics were used to summarize patient demographics, baseline characteristics, and study outcomes. The normality of data distribution was assessed using the Kolmogorov–Smirnov test. As most variables, except for age, were not normally distributed, non-parametric tests were used for analysis. The Friedman test was employed to evaluate changes in lagophthalmos severity over time in both the intervention and control eyes. The Wilcoxon signed-rank test was used to compare lagophthalmos severity between the intervention and control eyes within each group at each time point. The Mann–Whitney U test was used to compare the incidence of corneal abrasion among the three intervention groups. Statistical significance was set at p < 0.05 for all analyses.

Ethical considerations

This study was conducted in accordance with the Declaration of Helsinki and its later amendments. Ethical approval was obtained from the Ethics Committee of Kermanshah University of Medical Sciences (ethics code: 1395.177.kums.rec). The trial was registered with the Iranian Registry of Clinical Trials (IRCT201506294736N8) on July 2, 2016 (registration details available at www.IRCT.ir). Written informed consent was obtained from the legal representatives of all participants before enrollment, as patients were unable to provide consent themselves due to their medical condition. Participants’ representatives were informed about the study’s purpose, procedures, potential risks and benefits, and the voluntary nature of participation. They were assured of confidentiality regarding all personal and medical information.

Declaration of generative AI and AI-assisted technologies in the writing process

During the preparation of this work, the authors used Gemini-1.5-Pro to improve language and readability. After using this tool/service, the authors reviewed and edited the content as needed and took full responsibility for the content of the publication.

Results

Baseline characteristics

A total of 156 patients admitted to the ICU were enrolled in this study. The mean age of the participants was 52.8 ± 21.1 years, with a majority being male (n = 113, 73.0%). The average duration of ICU stay was 9.0 ± 2.0 days. There were no cases of loss to follow-up. Statistical analysis revealed no significant differences between the three intervention groups in terms of demographic characteristics or relevant clinical variables, including type of disease, duration of hospitalization, GCS score, use of sedatives, analgesics, or neuromuscular blockers, duration and dosage of sedative use, peak inspiratory pressure (PIP), and positive end-expiratory pressure (PEEP) (Table 1).Table 1 Demographic characteristics of the patients.

Variables	Groups	P-value	
Polyethylene cover (n = 52)	Polyethylene cover and artificial tear drop (n = 52)	Polyethylene cover and Lubratex ointment (n = 52)	
Age(mean ± SD)	53.0 ± 20.5	51.3 ± 19.7	4.2 ± 1.5	NS†	
Sex (male: female)	33.6:32.6	32.7:34.9	33.6:32.6	NS	
Marital status (single: married)	32.5:33.6	45.0:29.0	22.5:37.0	NS	
ICU‡ length of stay(mean ± SD)	10.0 ± 3.0	9.0 ± 2.0	9.0 ± 20.0	NS	
GCS§ (mean ± SD)	5.0 ± 1.0	6.0 ± 1.0	6.0 ± 1.0	NS	
Days of sedation(mean ± SD)	0.0 ± 1.0	1.0 ± .1.0	1.0 ± 1.0	NS	
Use of sedation (% of patients)	27.0	39.0	34.0	NS	
PIPǁ (mean ± SD)	21.0 ± 4.8	21.0 ± 4.0	20.0 ± 2.0	NS	
PEEP‡‡(mean ± SD)	5.0 ± 1.0	0.0 ± 5.0	5.0 ± 0.0	NS	
Diagnosis(trauma: neurosurgical: medical)	27:27:40	41.9:36.4:25	30.6:36.4:34.7	NS	
†NS: Non-significant; ‡ICU: Intensive Care Unit; §GCS: Glasgow Coma Scale; ǁPIP: Peak Inspiratory Pressure; ‡‡PEEP: Positive End-Expiratory Pressure.

Lagophthalmos severity

In the polyethylene cover group, a statistically significant difference in lagophthalmos severity was observed between the intervention and control eyes on day 1 (p = 0.03), with the intervention eye showing less corneal exposure. However, this difference was not maintained in the subsequent study days. While lagophthalmos severity increased in both eyes from day 2 to day 4 and then decreased on day 5, these changes were not statistically significant.

In the polyethylene cover with artificial tears group and the polyethylene cover with ointment group, lagophthalmos severity showed an increasing trend until day 5, but these changes were not statistically significant throughout the study period.

Corneal abrasion incidence

No statistically significant difference in corneal abrasion incidence was observed between the control and intervention eyes in any of the three groups from day 1 to day 4. However, on day 5, a significant difference emerged:Polyethylene cover group: Corneal abrasion was present in 58.0% (n = 30) of control eyes and 23.0% (n = 15) of intervention eyes (p < 0.001).

Polyethylene cover with artificial tears group: Corneal abrasion was present in 58.0% (n = 30) of control eyes and 17.0% (n = 9) of intervention eyes (p < 0.001).

Polyethylene cover with eye ointment group: Corneal abrasion was present in 58.0% (n = 30) of control eyes and 2.0% (n = 1) of intervention eyes (p < 0.001).

No statistically significant difference in corneal abrasion incidence was observed between the control and intervention eyes in any of the three groups from day 1 to day 4. However, on day 5, a significant difference emerged: corneal abrasion was present in 58.0% (n = 30) of control eyes and 23.0% (n = 15) of intervention eyes (p < 0.001) in the polyethylene cover group, corneal abrasion was present in 58.0% (n = 30) of control eyes and 17.0% (n = 9) of intervention eyes (p < 0.001) in the polyethylene cover with artificial tears group, and corneal abrasion was present in 58.0% (n = 30) of control eyes and 2.0% (n = 1) of intervention eyes (p < 0.001) in the polyethylene cover with eye ointment group (Table 2).Table 2 Corneal abrasion severity by eye and group over five days.

Study days	Fluorescein test result	Groups	
Polyethylene cover	Polyethylene cover and artificial tear drop	Polyethylene cover and Lubratex ointment	
Intervention n(%)	Control n(%)	p-value	Intervention n(%)	Control n(%)	p-value	Intervention n(%)	Control n(%)	p-value	
First	Positive	0 (0.0)	0 (0.0)	N/A	0 (0.0)	0 (0.0)	N/A	0 (0.0)	0 (0.0)	N/A	
Negative	52(100)	52(100)	52(100)	52(100)	52(100)	52(100)	
Second	Positive	0 (0.0)	0 (0.0)	N/A	0 (0.0)	0 (0.0)	N/A	0 (0.0)	0 (0.0)	N/A	
Negative	52(100)	52(100)	52(100)	52(100)	52(100)	52(100)	
Third	Positive	0 (0.0)	4(8.0)	N/A	0 (0.0)	2 (4.0)	N/A	0 (0.0)	2(4.0)	N/A	
Negative	52(100)	48(92.0)	52(100)	50(96.0)	52(100)	50(96.0)	
Fourth	Positive	0 (0.0)	17(33.0)	N/A	0 (0.0)	6(12.0)	N/A	0 (0.0)	12(24.0)	N/A	
Negative	52(100)	35(67.0)	52(100)	46(88.0)	52(100)	40(56.0)	
Fifth	Positive	15(23.0)	30(58.0)	 < .001	9(17.0)	30(58.0)	 < .040	1(2.0)	30(58.0)	 < .001	
Negative	37(71.0)	22(42.0)	43(83.0)	22(42.0)	51(98.0)	22(42.0)	
†NS Non-significant.

Furthermore, a statistically significant difference in corneal abrasion severity on day 5 was observed between the three intervention groups (p < 0.001). The polyethylene cover group had the highest incidence of corneal abrasion (60.0%), followed by the polyethylene cover with artificial tears group (36.0%). The polyethylene cover with eye ointment group had the lowest incidence (4.0%) (Table 3).Table 3 Severity of corneal abrasion on day five by intervention group.

Fluorescein test result	Groups	P-value	
Polyethylene cover, n (%)	Polyethylene cover and artificial tear drop, n (%)	Polyethylene cover and Lubratex ointment, n (%)	Control, n (%)	
Positive	15(60.0)	9(36.0)	1(4.0)	30(58.0)	 < .001	
Negative	37(28.2)	43(38.2)	51(38.9)	22(42.0)	

Discussion

This clinical trial evaluated the effectiveness of three eye care methods for preventing corneal abrasions in critically ill patients: “polyethylene cover,” “polyethylene cover with artificial tear drops,” and “polyethylene cover with Lubratex eye ointment.” The results demonstrated that the use of a polyethylene cover with Lubratex ointment was significantly more effective in preventing corneal abrasions compared to the other two methods.

The efficacy of various eye care methods in preventing corneal damage among intubated and unconscious ICU patients has been the subject of numerous clinical trials, yielding inconsistent results. For instance, Hayakawa et al.6 conducted a similar study comparing polyethylene cover and eye irrigation with 0.9% saline solution, concluding that the polyethylene cover method was superior in preventing corneal damage6. Similarly, Shan et al.23 compared artificial tear drops, humidified chambers, and polyethylene covers in 84 critically ill intubated ICU patients, finding that while both polyethylene cover and humidified chambers were more effective than artificial tear drops, there was no statistically significant difference between the two23. However, contrasting findings were reported in a 2018 clinical trial comparing polyethylene cover and vitamin A eye ointment for preventing eye surface disease in ventilated ICU patients, where vitamin A ointment proved more effective24.

Aligning with the current study’s findings, Khatiban et al.8 compared polyethylene cover, artificial tear drops, and normal saline, concluding that the protective layer provided by polyethylene was significantly more effective in reducing the severity of ocular surface diseases (OSD)8. Ahmadinejad et al.22 also found both ointment and polyethylene cover to be significantly more effective than eyelid taping in preventing OSD, although no significant difference was observed between the two22. Further supporting the benefits of a combined approach, a clinical trial investigating keratopathy reduction found that combining eye drops with polyethylene cover was more effective than eye drops alone25. This aligns with the current study’s findings, where the polyethylene film created a closed moist chamber, which, in conjunction with eye lubricant, effectively reduced corneal abrasions and surface eye injuries. Similarly, a 2021 clinical trial comparing an eye care protocol (eye wash + Duratear ointment + GladWrap) with routine care (eye wash and eyelid taping) in 32 critically ill ICU patients with decreased consciousness found the protective covering provided by the eye care protocol more effective26.

Several clinical trials have investigated open chamber methods (eye lubricants and eyelid taping) without polyethylene film, yielding varied results5,15,17,27,28. Lee SJ et al.17 found no significant difference in corneal abrasion prevention between ointment, ointment with eyelid taping, eyelid taping alone, and closing the eyes with the hand17. However, this study did not employ any eye-covering method. Similarly, no significant difference was observed between vitamin A ointment and simple eye ointment in a 2021 clinical trial involving 41 ICU patients5, nor between moist gauze, hypoallergenic tape, and tetracycline ointment in a study on patients undergoing general anesthesia15. These studies relied solely on maintaining eye surface moisture without addressing corneal exposure.

Contrasting findings were reported by a 2019 clinical trial that found artificial tears gel more effective than liquid artificial tears in preventing corneal dryness and surface eye injury27. However, both methods used an open moist chamber approach. Finally, a 2012 clinical trial comparing eyelid taping, artificial tear drops, antibiotic eye ointment, and lubricant eye ointment in 184 patients undergoing general anesthesia found no significant difference between the methods28.

Limitations

This study has several limitations that warrant consideration. First, the majority of patients had diagnoses of cerebrovascular accident or head injury, necessitating frequent pupillary examinations. This requirement led to the repeated removal and replacement of the polyethylene covers, potentially affecting their fit and, consequently, the study outcomes. Second, the study's intervention duration was limited due to financial constraints, potentially impacting the observation of long-term effects. Finally, the study did not control for the age range of participants. This is a notable limitation as older individuals may experience more rapid changes in fluid volume, making them more susceptible to dehydration and, consequently, OSD29.

Conclusion

This study evaluated the effectiveness of three ocular care methods for preventing corneal abrasion in ICU patients: polyethylene cover alone, polyethylene cover with artificial tear drops, and polyethylene cover with Lubratex eye ointment. The findings demonstrate that the combined use of polyethylene cover and Lubratex eye ointment was significantly more effective in preventing corneal abrasion than the other two methods. Therefore, this combined approach is recommended for the prevention of ocular injuries in ICU patients.

Future research should explore the comparative effectiveness of preserved and preservative-free artificial tear drops in conjunction with polyethylene covers. Additionally, investigating alternative closed reservoir approaches could provide valuable insights into further reducing the incidence of corneal abrasion in this patient population.

Ethics approval and consent to participate

The study was approved by the Ethics Committee of Kermanshah University of Medical Sciences, with the ethics code IR.KUMS.REC. 1395.177. It was registered with the Iranian Registry of Clinical Trials under the code IRCT201506294736N8 on 31 March 2019, accessible at www.IRCT.ir. Due to the patients' unconsciousness, written informed consent was obtained from the primary caregivers, ensuring them that personal information and patient-related data would remain confidential. The experiment protocol for involving humans was in accordance with the guidelines of the national, international, institutional, or Declaration of Helsinki.

Acknowledgements

This research was conducted as part of a larger study funded by the Student Research Committee of Kermanshah University of Medical Sciences (Grant No. 95454). The investigators extend their sincere gratitude to the patients who participated in this study.

Author contributions

TN, ES, MR, and AK contributed to designing the study. TN and ES collected the data, and the data was analyzed by MR. The final report and manuscript were written by TN and Ak. All the authors read and approved the version for submission.

Funding

The research was financially supported by Kermanshah University of Medical Sciences (http://www.kums.ac.ir/) under Grant No. 95454, with Alireza Khatony as the grant recipient.

Data availability

The identified datasets analyzed during the current study are available from the corresponding author upon reasonable request.

Competing interests

The authors declare no competing interests.

Publisher's note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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