AbstractCorneal 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.

摘要角膜磨损是危重症插管患者的常见并发症，可能导致视力障碍。这项研究比较了三种眼部护理方法在预防这一弱势人群角膜磨损方面的功效。我们进行了一项随机对照试验，涉及156名入住ICU的插管成年患者。

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.

参与者被随机分配到三个干预组中的一个（每组n=52）：（1）仅聚乙烯盖，（2）带有人工泪液的聚乙烯盖，以及（3）带有Lubratex眼膏的聚乙烯盖。每位患者随机分配一只眼睛作为对照，接受标准的ICU眼科护理。

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).

五天内的日常评估包括标准化的干燥和角膜磨损检查表，眼睛干燥的分级条评估以及角膜磨损发生率的记录。使用描述性和推论统计（SPSS-18）分析数据。与人工泪液聚乙烯覆盖组（36%，p<0.001）和仅聚乙烯覆盖组（60%）相比，接受Lubratex眼膏聚乙烯覆盖组（4%）的角膜磨损发生率显着降低，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.

聚乙烯盖与Lubratex眼膏的联合应用有效地防止了插管ICU患者的角膜磨损。与单独使用或与人工泪液一起使用的聚乙烯盖相比，该方法显示出优越的功效。我们建议将其作为高危人群角膜磨损预防的标准实践。试用注册。

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

这项研究已在伊朗临床试验注册处（IRCT201506294736N8）注册，可访问www.IRCT.ir。。

IntroductionCritically ill patients often require life-saving interventions that inadvertently increase their risk of ocular surface complications1,2,3,4. Sedation, mechanical ventilation, and the use of certain medications can disrupt normal tear production and eyelid function, leaving the cornea vulnerable to injury5,6,7,8,9.

引言危重病人通常需要救生干预措施，无意中增加了眼表并发症的风险1,2,3,4。镇静，机械通气和使用某些药物会破坏正常的泪液产生和眼睑功能，使角膜容易受伤5,6,7,8,9。

Among these complications, corneal abrasion presents a significant concern, potentially leading to scarring, vision impairment, and prolonged hospital stays10,11,12,13.While the reported prevalence of corneal abrasion in intensive care unit (ICU) patients varies11,14, its impact underscores the need for effective preventative measures.

在这些并发症中，角膜磨损是一个值得关注的问题，可能导致疤痕，视力障碍和住院时间延长[10,11,12,13]。尽管据报道重症监护病房（ICU）患者角膜磨损的患病率各不相同[11,14]，但其影响强调了需要有效的预防措施。

Numerous studies have investigated various ocular care strategies, including polyethylene films, artificial tear drops, ointments, and eyelid taping5,6,7,8,15,16,17. 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.

许多研究调查了各种眼部护理策略，包括聚乙烯薄膜，人工泪液，软膏和眼睑贴5,6,7,8,15,16,17。然而，这些试验产生了不一致的发现，临床医生对最佳方法没有明确的共识。一些研究支持聚乙烯覆盖物而不是其他方法8，而另一些研究则报告了不同干预措施之间的可比疗效17。这种缺乏标准化以及与角膜磨损相关的显着发病率，需要进一步研究针对这一弱势患者群体的最有效预防策略。

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:.

这项随机对照试验旨在直接比较插管ICU患者角膜保护的三种常用方法：（1）单独使用聚乙烯盖，（2）使用人工泪液的聚乙烯盖，以及（3）使用Lubratex眼膏的聚乙烯盖。具体而言，这项研究解决了以下问题：。

1. What is the progression of corneal abrasion severity from day one to day five in each intervention group?

1.每个干预组从第1天到第5天角膜磨损严重程度的进展如何？

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

2、在为期五天的研究期间，这三种方法在预防角膜磨损发生方面的效果如何？

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

三种方法中哪一种在预防角膜擦伤方面表现出最高的功效？

Materials and methodsStudy designThis 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.

材料与方法研究设计这项前瞻性，平行组，随机对照试验采用1:1:1的分配比例来比较三种角膜保护方法在预防磨损方面的功效。该研究遵循报告试验综合标准（CONSORT）指南1（图1）。图。

1The CONSORT diagram of the study.Full size imageStudy hypothesisWe 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 settingThis 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.

1研究的CONSORT图。全尺寸图像研究假设我们假设三个干预组的角膜磨损发生率会有显着差异：（1）单独使用聚乙烯覆盖物，（2）使用人工泪液的聚乙烯覆盖物，以及（3）使用Lubratex眼膏的聚乙烯覆盖物。参与者和设置这项研究包括156名成年患者（≥18岁），他们入住伊朗西部伊拉姆伊玛目霍梅尼和莫斯塔法霍梅尼医院的重症监护病房（ICU）。

These hospitals have a combined total of 24 ICU beds.Sample size and randomizationThe 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.

这些医院总共有24张ICU病床。样本量和随机化样本量是根据Cortese等人19和Koroloff等人20之前的研究计算的，目标是置信水平为95%，功效为80%2,3。使用简单的随机抽样方法，使用计算机生成的随机数字表将参与者分配到三个干预组之一。

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.BlindingA single-blind approach was implemented, with the statistician blinded to the group assignments throughout data analysis.Inclusion and exclusion criteriaThe 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, an.

每个参与者的一只眼睛被随机指定为“干预眼”，而另一只眼睛被指定为“对照眼”。分配过程由第一作者执行。盲法实施了单盲方法，统计学家在整个数据分析过程中对小组任务不知情。纳入和排除标准纳入标准为：年龄≥18岁，格拉斯哥昏迷量表（GCS）评分≤8，使用神经肌肉阻滞剂和镇静药物，插管，阴性Schirmer和荧光素检测结果，无眼部疾病史。

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.

聚乙烯盖：使用无菌一次性聚乙烯眼罩（伊朗帕斯阿特拉斯公司）为角膜提供保护屏障。聚乙烯是一种通用的防潮塑料，常用于医疗环境11,21。

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

人工泪液滴眼液：使用含泪液的人工泪液滴眼液（含有羟丙基甲基纤维素）来补充天然泪液的产生8。

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

Lubratex眼膏：Lubratex无菌眼膏（伊朗Sina Darou公司）用于提供润滑和防止角膜干燥。

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

眼干燥测量：使用无菌SM管条（日本）评估泪膜稳定性并评估眼干燥。

InterventionsThis 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:.

干预本研究是作为第一作者论文较大研究项目的一部分进行的。入组前，所有患者均接受了全面的眼科检查，以确认没有预先存在的角膜磨损或明显的干眼症。该基线评估包括：。

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.

Schirmer试验：使用Schirmer试验评估撕裂产生，结果在分级带上润湿5毫米或以上被认为是正常的。

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.

荧光素染色：眼表面用荧光素染色，并使用手持式裂隙灯检查角膜，以排除任何预先存在的擦伤。

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

兔眼评估：使用六点兔眼强度检查表评估兔眼程度（不完全眼睑闭合）。

Patients without evidence of corneal abrasion or significant dry eye were then randomly assigned to one of three intervention groups (n = 52 per group):

然后将没有角膜磨损或明显干眼症证据的患者随机分配到三个干预组之一（每组52例）：

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.

聚乙烯盖组：将无菌透明聚乙烯眼罩应用于干预眼，用从眉毛上方延伸至颧骨的低致敏胶带固定。如果盖子被弄脏、损坏或脱落，则每天或更早更换。

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.

聚乙烯盖人工泪液组：除聚乙烯盖外，每8小时向干预眼滴入一滴无泪人工泪液。

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.

聚乙烯盖Lubratex眼膏组：在聚乙烯盖的同时，每8小时将少量Lubratex无菌眼膏涂抹在干预眼的下眼睑边缘。

Control group and study durationThe 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.

对照组和研究持续时间每位参与者的对照眼每8小时接受一次标准的ICU眼部护理，包括用无菌蒸馏水和纱布轻轻清洁眼睑，睫毛和周围皮肤。所有干预和评估均连续五天进行。

Daily examinations by the ophthalmologist were performed to assess for corneal abrasion and document any adverse events, using standardized data collection forms22.Statistical analysisData were analyzed using SPSS software, version 18 (IBM Corp., Armonk, NY). Descriptive statistics were used to summarize patient demographics, baseline characteristics, and study outcomes.

使用标准化的数据收集表格22，眼科医生进行日常检查以评估角膜磨损并记录任何不良事件。统计分析使用SPSS软件18版（IBM Corp.，Armonk，NY）分析数据。描述性统计用于总结患者人口统计学，基线特征和研究结果。

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.

使用Kolmogorov–Smirnov检验评估数据分布的正态性。由于除年龄外，大多数变量均非正态分布，因此使用非参数检验进行分析。弗里德曼测试用于评估干预眼和对照眼的眼睑炎严重程度随时间的变化。

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 considerationsThis study was conducted in accordance with the Declaration of Helsinki and its later amendments.

Wilcoxon符号秩和检验用于比较每组干预眼和对照眼在每个时间点的眼睑炎严重程度。Mann-Whitney U检验用于比较三个干预组之间角膜磨损的发生率。所有分析的统计学显着性均设定为p<0.05。伦理考虑这项研究是根据《赫尔辛基宣言》及其后来的修正案进行的。

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 le.

获得了科尔曼沙赫医科大学伦理委员会的伦理批准（伦理代码：1395.177。kums。rec）。该试验于2016年7月2日在伊朗临床试验注册处（IRCT201506294736N8）注册（注册详情可在www.IRCT.ir获得）。书面知情同意书已从le获得。

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).

聚乙烯覆盖组：58.0%（n=30）的对照眼和23.0%（n=15）的干预眼存在角膜磨损（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).

聚乙烯覆盖人工泪液组：对照眼58.0%（n=30）和干预眼17.0%（n=9）存在角膜磨损（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).

聚乙烯眼膏组：58.0%（n=30）的对照眼和2.0%（n=1）的干预眼存在角膜磨损（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.Full size tableFurthermore, a statistically significant difference in corneal abrasion severity on day 5 was observed between the three intervention groups (p < 0.001).

从第1天到第4天，在三组中的任何一组中，对照眼和干预眼之间没有观察到角膜磨损发生率的统计学显着差异。然而，在第5天，出现了显着差异：对照眼的角膜磨损率为58.0%（n=30），干预眼的角膜磨损率为23.0%（n=15）（p<0.001）聚乙烯覆盖组，对照眼的角膜磨损率为58.0%（n=30），干预眼的角膜磨损率为17.0%（n=9）（p<0.001）在聚乙烯眼膏覆盖组中，58.0%（n=30）的对照眼和2.0%（n=1）的干预眼存在角膜磨损（p<0.001）（表2）。表2五天内眼睛和组的角膜磨损严重程度。全尺寸表此外，在三个干预组之间观察到第5天角膜磨损严重程度的统计学显着差异（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.Full size tableDiscussionThis 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 cornea.

聚乙烯覆盖组角膜磨损发生率最高（60.0%），其次是聚乙烯覆盖人工泪液组（36.0%）。聚乙烯眼膏组的发生率最低（4.0%）（表3）。表3干预组第五天角膜磨损的严重程度。全尺寸表讨论该临床试验评估了三种眼部护理方法预防危重患者角膜擦伤的有效性：“聚乙烯盖”，“聚乙烯盖人工泪液”和“聚乙烯盖Lubratex眼膏”。结果表明，与其他两种方法相比，使用聚乙烯盖Lubratex软膏在预防角膜擦伤方面显着更有效。各种眼部护理方法预防角膜的效果。

Data availability

数据可用性

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

在当前研究期间分析的已识别数据集可根据合理要求从通讯作者处获得。

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Download referencesAcknowledgementsThis 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.FundingThe research was financially supported by Kermanshah University of Medical Sciences (http://www.kums.ac.ir/) under Grant No.

下载参考文献致谢本研究是由科尔曼沙赫医科大学学生研究委员会（批准号95454）资助的一项较大研究的一部分。研究人员向参与这项研究的患者表示衷心的感谢。资助这项研究得到了科尔曼沙赫医科大学的财政支持(http://www.kums.ac.ir/)根据批准号。

95454, with Alireza Khatony as the grant recipient.Author informationAuthors and AffiliationsStudent Research Committee, Kermanshah University of Medical Sciences, Kermanshah, IranTahere NiksereshtSocial Development and Health Promotion Research Center, Kermanshah University of Medical Sciences, Kermanshah, IranMansour Rezaei, Elahe Sharifian & Alireza KhatonyInfectious Diseases Research Center, Kermanshah University of Medical Sciences, Kermanshah, IranAlireza KhatonyAuthorsTahere NiksereshtView author publicationsYou can also search for this author in.

95454，Alireza Khatony作为赠款接受者。作者信息作者和附属机构学生研究委员会，科尔曼沙赫医科大学，科尔曼沙赫，伊朗尼克斯雷什社会发展与健康促进研究中心，科尔曼沙赫医科大学，科尔曼沙赫，伊朗曼苏尔雷扎伊，埃拉赫·谢里菲和阿里雷扎·哈顿传染病研究中心，科尔曼沙赫医科大学，科尔曼沙赫，伊朗纳利扎·哈顿作者NiksereshtView作者出版物你也可以在中搜索这位作者。

PubMed Google ScholarMansour RezaeiView author publicationsYou can also search for this author in

PubMed Google ScholarMansour RezaeiView作者出版物您也可以在

PubMed Google ScholarElahe SharifianView author publicationsYou can also search for this author in

PubMed Google ScholarElahe SharifianView作者出版物您也可以在

PubMed Google ScholarAlireza KhatonyView author publicationsYou can also search for this author in

PubMed Google ScholarAlireza KhatonyView作者出版物您也可以在

PubMed Google ScholarContributionsTN, 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.Corresponding authorCorrespondence to.

PubMed Google ScholarContributionsTN，ES，MR和AK为设计这项研究做出了贡献。TN和ES收集了数据，并由先生分析了数据。最终报告和手稿由TN和Ak撰写。所有作者都阅读并批准了提交的版本。对应作者对应。

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Reprints and permissionsAbout this articleCite this articleNikseresht, T., Rezaei, M., Sharifian, E. et al. Lubratex eye ointment with polyethylene cover significantly reduces corneal abrasion in ICU patients: a randomized controlled trial.

转载和许可本文引用本文Nikseresht，T.，Rezaei，M.，Sharifian，E。等人。带有聚乙烯盖的Lubratex眼膏可显着减少ICU患者的角膜磨损：一项随机对照试验。

Sci Rep 14, 20443 (2024). https://doi.org/10.1038/s41598-024-71601-1Download citationReceived: 11 April 2024Accepted: 29 August 2024Published: 03 September 2024DOI: https://doi.org/10.1038/s41598-024-71601-1Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

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