Lubricating drops for contact lens discomfort in adults.

IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Cochrane Database of Systematic Reviews Pub Date : 2024-09-05 DOI:10.1002/14651858.CD015751.pub2
Barbara Caffery, Andrew D Pucker, Ngozi C Chidi-Egboka, Chukwuemeka Junior Obinwanne, Brooke Harkness, Nicole A Carnt, Su-Hsun Liu, Alison Ng
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Eye care specialists often treat contact lens discomfort with lubricating drops, including saline, although there is no clear evidence showing this treatment is effective and safe.</p><p><strong>Objectives: </strong>To evaluate the efficacy and safety of lubricating drops for ocular discomfort associated with contact lens wear in adults.</p><p><strong>Search methods: </strong>We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase.com, two other databases, and two trials registries to May 2024, without date or language restrictions.</p><p><strong>Selection criteria: </strong>We included parallel-group randomized controlled trials (RCTs) that evaluated lubricating drops, including saline, versus no treatment, or that evaluated lubricating drops versus saline, in adult contact lens wearers. We included studies regardless of publication status, language, or year of publication.</p><p><strong>Data collection and analysis: </strong>We applied standard Cochrane methodology. The critical outcome was contact lens discomfort. Important outcomes were corneal fluorescein staining and conjunctival redness. Adverse outcomes were incident microbial keratitis, inflammatory corneal infiltrates, and participant discontinuation. We assessed risk of bias for outcomes reported in the summary of findings table using the Cochrane risk of bias tool RoB 2, and we rated the certainty of the evidence using GRADE.</p><p><strong>Main results: </strong>We included seven RCTs conducted in the USA, Canada, Italy, and France. They randomized a total of 463 participants to lubricating drops, saline, or no treatment. Four trials evaluated lubricating drops and saline versus no treatment, but one of them provided no usable outcome data. Three trials evaluated lubricating drops versus saline. Study characteristics All trial participants were adults, and the mean age ranged from 25.7 years to 36.7 years. The proportion of women varied from 15% to 82%. The trials lasted between one and four weeks. Of the five trials that reported contact lens discomfort, we judged three at high risk of bias, and considered the other two had some risk of bias concerns. Lubricating drops (including saline) versus no treatment Lubricating drops compared with no treatment may reduce contact lens discomfort, measured on a 37-point scale (lower is better), but the evidence is very uncertain (mean difference [MD] -5.9 points, 95% confidence interval [CI] -3.74 to -8.05; 2 RCTs; 119 participants). One trial found no difference between lubricating drops and no treatment in \"end-of-day\" comfort. The trial that compared saline with no treatment provided no results for the control group. Two studies measured corneal fluorescein staining on a scale of 0 to 20 (lower is better). We found low-certainty evidence of little to no difference between lubricating drops and no treatment in changes in the extent (MD -0.15 points, 95% CI -0.86 to 0.56; 2 RCTs; 119 participants), depth (MD -0.01 points, 95% CI -0.44 to 0.42; 2 RCTs; 119 participants), or type (MD 0.04 points, 95% CI -0.38 to 0.46; 2 RCTs; 119 participants) of corneal fluorescein staining scores. Regarding conjunctival redness, measured on a scale of 0 to 4 (lower is better), there was low-certainty evidence of little to no difference between lubricating drops and no treatment in nasal region scores (MD 0.10, 95% CI -0.29 to 0.49; 1 RCT; 73 participants) and temporal region scores (MD 0.00, 95% CI -0.39 to 0.39; 1 RCT; 73 participants). No studies reported microbial keratitis or inflammatory corneal infiltrates, and no trials reported vision-threatening adverse events up to four weeks of treatment. All trials reported the proportion of participants who discontinued participation. In two trials, no participants left any treatment group. Our meta-analysis of another two studies suggests little difference in the number of people who dropped out of the lubricating treatment group versus the no treatment group (risk ratio [RR] 1.42, 95% CI 0.19 to 10.94; 138 participants; low-certainty evidence). Lubricating drops versus saline Lubricating drops may have little to no effect compared with saline on contact lens discomfort measured on a visual analog scale of 0 to 100 (lower is better), but the evidence is very uncertain (MD 9.5 points, 95% CI -4.65 to 23.65; 1 RCT; 39 participants). No studies reported corneal fluorescein staining or conjunctival redness. No studies reported microbial keratitis or inflammatory corneal infiltrates, and no trials reported vision-threatening adverse events up to four weeks of treatment. Our meta-analysis of three studies suggests little difference in the number of people who dropped out of the lubricating treatment group versus the saline group (RR 1.56, 95% CI 0.47 to 5.12; 269 participants; low-certainty evidence).</p><p><strong>Authors' conclusions: </strong>Very low-certainty evidence suggests that lubricating drops may improve contact lens discomfort compared with no treatment, but may have little or no effect on contact lens discomfort compared with saline. Low-certainty evidence also suggests that lubricating drops may have no unwanted effects that would lead to discontinuation over one to four weeks. Current evidence suggests that prescribing lubricating drops (including saline) to people with contact lens discomfort is a viable option. However, most studies did not assess patient-reported contact lens (dis)comfort using a validated instrument. 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引用次数: 0

Abstract

Background: Contact lens discomfort is a symptom-based clinical diagnosis that affects 13% to 75% of contact lens wearers. The Tear Film and Ocular Surface Society defines contact lens discomfort as "a condition characterized by episodic or persistent adverse ocular sensations related to lens wear either with or without visual disturbance, resulting from reduced compatibility between the lens and ocular environment, which can lead to decreased wearing time and discontinuation from lens wear." Signs of the condition include conjunctival hyperemia, corneal and conjunctival staining, altered blinking patterns, lid wiper epitheliopathy, and meibomian gland dysfunction. Eye care specialists often treat contact lens discomfort with lubricating drops, including saline, although there is no clear evidence showing this treatment is effective and safe.

Objectives: To evaluate the efficacy and safety of lubricating drops for ocular discomfort associated with contact lens wear in adults.

Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register), MEDLINE, Embase.com, two other databases, and two trials registries to May 2024, without date or language restrictions.

Selection criteria: We included parallel-group randomized controlled trials (RCTs) that evaluated lubricating drops, including saline, versus no treatment, or that evaluated lubricating drops versus saline, in adult contact lens wearers. We included studies regardless of publication status, language, or year of publication.

Data collection and analysis: We applied standard Cochrane methodology. The critical outcome was contact lens discomfort. Important outcomes were corneal fluorescein staining and conjunctival redness. Adverse outcomes were incident microbial keratitis, inflammatory corneal infiltrates, and participant discontinuation. We assessed risk of bias for outcomes reported in the summary of findings table using the Cochrane risk of bias tool RoB 2, and we rated the certainty of the evidence using GRADE.

Main results: We included seven RCTs conducted in the USA, Canada, Italy, and France. They randomized a total of 463 participants to lubricating drops, saline, or no treatment. Four trials evaluated lubricating drops and saline versus no treatment, but one of them provided no usable outcome data. Three trials evaluated lubricating drops versus saline. Study characteristics All trial participants were adults, and the mean age ranged from 25.7 years to 36.7 years. The proportion of women varied from 15% to 82%. The trials lasted between one and four weeks. Of the five trials that reported contact lens discomfort, we judged three at high risk of bias, and considered the other two had some risk of bias concerns. Lubricating drops (including saline) versus no treatment Lubricating drops compared with no treatment may reduce contact lens discomfort, measured on a 37-point scale (lower is better), but the evidence is very uncertain (mean difference [MD] -5.9 points, 95% confidence interval [CI] -3.74 to -8.05; 2 RCTs; 119 participants). One trial found no difference between lubricating drops and no treatment in "end-of-day" comfort. The trial that compared saline with no treatment provided no results for the control group. Two studies measured corneal fluorescein staining on a scale of 0 to 20 (lower is better). We found low-certainty evidence of little to no difference between lubricating drops and no treatment in changes in the extent (MD -0.15 points, 95% CI -0.86 to 0.56; 2 RCTs; 119 participants), depth (MD -0.01 points, 95% CI -0.44 to 0.42; 2 RCTs; 119 participants), or type (MD 0.04 points, 95% CI -0.38 to 0.46; 2 RCTs; 119 participants) of corneal fluorescein staining scores. Regarding conjunctival redness, measured on a scale of 0 to 4 (lower is better), there was low-certainty evidence of little to no difference between lubricating drops and no treatment in nasal region scores (MD 0.10, 95% CI -0.29 to 0.49; 1 RCT; 73 participants) and temporal region scores (MD 0.00, 95% CI -0.39 to 0.39; 1 RCT; 73 participants). No studies reported microbial keratitis or inflammatory corneal infiltrates, and no trials reported vision-threatening adverse events up to four weeks of treatment. All trials reported the proportion of participants who discontinued participation. In two trials, no participants left any treatment group. Our meta-analysis of another two studies suggests little difference in the number of people who dropped out of the lubricating treatment group versus the no treatment group (risk ratio [RR] 1.42, 95% CI 0.19 to 10.94; 138 participants; low-certainty evidence). Lubricating drops versus saline Lubricating drops may have little to no effect compared with saline on contact lens discomfort measured on a visual analog scale of 0 to 100 (lower is better), but the evidence is very uncertain (MD 9.5 points, 95% CI -4.65 to 23.65; 1 RCT; 39 participants). No studies reported corneal fluorescein staining or conjunctival redness. No studies reported microbial keratitis or inflammatory corneal infiltrates, and no trials reported vision-threatening adverse events up to four weeks of treatment. Our meta-analysis of three studies suggests little difference in the number of people who dropped out of the lubricating treatment group versus the saline group (RR 1.56, 95% CI 0.47 to 5.12; 269 participants; low-certainty evidence).

Authors' conclusions: Very low-certainty evidence suggests that lubricating drops may improve contact lens discomfort compared with no treatment, but may have little or no effect on contact lens discomfort compared with saline. Low-certainty evidence also suggests that lubricating drops may have no unwanted effects that would lead to discontinuation over one to four weeks. Current evidence suggests that prescribing lubricating drops (including saline) to people with contact lens discomfort is a viable option. However, most studies did not assess patient-reported contact lens (dis)comfort using a validated instrument. Therefore, further well-designed trials are needed to generate high-certainty evidence on patient-reported outcomes as well as on longer-term safety outcomes.

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治疗成人隐形眼镜不适的润滑滴剂。
背景:隐形眼镜不适是一种基于症状的临床诊断,影响 13% 至 75% 的隐形眼镜佩戴者。泪膜与眼表协会将隐形眼镜不适定义为 "一种因镜片与眼部环境的兼容性降低而导致的偶发性或持续性眼部不良感觉,无论是否伴有视觉障碍"。这种症状的体征包括结膜充血、角膜和结膜染色、眨眼模式改变、睑板腺上皮病变和睑板腺功能障碍。眼科专家通常会使用包括生理盐水在内的润滑滴眼液来治疗隐形眼镜不适,但目前还没有明确的证据表明这种治疗方法是有效和安全的:目的:评估润滑滴眼液治疗成人配戴隐形眼镜引起的眼部不适的有效性和安全性:我们检索了 CENTRAL(包含 Cochrane Eyes and Vision Trials Register)、MEDLINE、Embase.com、其他两个数据库和两个试验登记处,检索期至 2024 年 5 月,无日期和语言限制:我们纳入了针对成人隐形眼镜佩戴者的平行组随机对照试验(RCT),这些试验评估了润滑滴剂(包括生理盐水)与无治疗的对比,或润滑滴剂与生理盐水的对比。数据收集与分析:我们采用了标准的 Cochrane 方法。关键结果是隐形眼镜不适。重要结果是角膜荧光素染色和结膜发红。不良结果为偶发微生物性角膜炎、炎症性角膜浸润和参与者停用。我们使用科克伦偏倚风险工具 RoB 2 对研究结果摘要表中报告的结果进行了偏倚风险评估,并使用 GRADE 对证据的确定性进行了评级:我们纳入了在美国、加拿大、意大利和法国进行的七项 RCT 研究。这些试验共随机抽取了 463 名参与者,让他们接受润滑滴剂、生理盐水或无治疗。四项试验对滴入润滑剂和生理盐水与不进行治疗进行了评估,但其中一项试验未提供可用的结果数据。三项试验对润滑滴剂和生理盐水进行了评估。研究特点 所有试验参与者均为成年人,平均年龄从25.7岁到36.7岁不等。女性比例从15%到82%不等。试验持续时间从一周到四周不等。在报告了隐形眼镜不适症状的五项试验中,我们认为其中三项存在较高的偏倚风险,另外两项存在一定的偏倚风险。润滑滴剂(包括生理盐水)与无治疗相比 润滑滴剂与无治疗相比可能会减轻隐形眼镜不适感(以 37 分制衡量(越低越好)),但证据非常不确定(平均差异 [MD] -5.9 分,95% 置信区间 [CI] -3.74 至 -8.05;2 项 RCT;119 名参与者)。一项试验发现,在 "日终 "舒适度方面,润滑滴剂与无治疗之间没有差异。将生理盐水与无治疗进行比较的试验未提供对照组的结果。两项研究对角膜荧光素染色进行了测量,测量值从 0 到 20(越低越好)。我们发现,有低确定性证据表明,在角膜荧光素染色评分的范围(MD -0.15分,95% CI -0.86至0.56;2项研究;119名参与者)、深度(MD -0.01分,95% CI -0.44至0.42;2项研究;119名参与者)或类型(MD 0.04分,95% CI -0.38至0.46;2项研究;119名参与者)的变化方面,润滑滴剂与不治疗几乎没有差异。关于结膜发红(以 0 到 4 分(越低越好)为衡量标准),有低确定性证据表明,在鼻腔区域评分(MD 0.10,95% CI -0.29 到 0.49;1 项研究疗法;73 名参与者)和颞部区域评分(MD 0.00,95% CI -0.39 到 0.39;1 项研究疗法;73 名参与者)方面,滴用润滑剂和不使用治疗方法几乎没有差异。没有研究报告了微生物性角膜炎或炎症性角膜浸润,也没有试验报告了治疗四周内危及视力的不良事件。所有试验都报告了中止参与的参与者比例。在两项试验中,没有参与者退出任何治疗组。我们对另外两项研究进行的荟萃分析表明,润滑治疗组与无治疗组的退出人数差别不大(风险比 [RR] 1.42,95% CI 0.19 至 10.94;138 名参与者;低确定性证据)。润滑滴剂与生理盐水的比较 润滑滴剂与生理盐水相比,对隐形眼镜不适感的影响可能微乎其微,以 0 至 100 分的视觉模拟量表测量(越低越好),但证据非常不确定(MD 9.5 分,95% CI -4.65 至 23.65;1 项 RCT;39 名参与者)。
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来源期刊
CiteScore
10.60
自引率
2.40%
发文量
173
审稿时长
1-2 weeks
期刊介绍: The Cochrane Database of Systematic Reviews (CDSR) stands as the premier database for systematic reviews in healthcare. It comprises Cochrane Reviews, along with protocols for these reviews, editorials, and supplements. Owned and operated by Cochrane, a worldwide independent network of healthcare stakeholders, the CDSR (ISSN 1469-493X) encompasses a broad spectrum of health-related topics, including health services.
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