背景:隐形眼镜不适是一种基于症状的临床诊断,影响了13%至75%的隐形眼镜佩戴者。泪膜和眼表协会将隐形眼镜不适定义为“一种症状,其特征是与佩戴或不伴有视觉障碍的镜片相关的偶发性或持续性不良眼感。由于晶状体和眼部环境之间的兼容性降低,这可能导致佩戴时间减少和镜片佩戴中断。“这种情况的迹象包括结膜充血,角膜和结膜染色,改变了闪烁的模式,眼睑刮水器上皮病变,睑板腺功能障碍.眼部护理专家经常用润滑滴剂治疗隐形眼镜不适,包括生理盐水,尽管没有明确的证据表明这种治疗是有效和安全的。
目的:评估润滑滴剂对成人配戴隐形眼镜引起的眼部不适的疗效和安全性。
方法:我们搜索了CENTRAL(包含Cochrane眼睛和视力试验注册),MEDLINE,Embase.com,另外两个数据库,以及至2024年5月的两项试验登记处,没有日期或语言限制。
方法:我们包括评估润滑滴剂的平行组随机对照试验(RCT),包括生理盐水,与不治疗相比,或者评估润滑滴与盐水的关系,成人隐形眼镜配戴者。我们纳入了研究,无论发表状态如何,语言,或出版年份。
方法:我们采用了标准Cochrane方法。关键结果是隐形眼镜不适。重要的结果是角膜荧光素染色和结膜红肿。不良结局是微生物性角膜炎,炎性角膜浸润,参与者停止。我们使用Cochrane偏倚风险工具RoB2评估结果汇总表中报告的偏倚风险,并使用GRADE对证据的确定性进行评级。
结果:我们包括在美国进行的七个RCT,加拿大,意大利,和法国。他们将总共463名参与者随机分配到润滑滴剂中,盐水,或者没有治疗。四项试验评估了润滑滴剂和盐水与不治疗的情况。但是其中一个没有提供可用的结果数据。三个试验评估了相对于盐水的润滑滴。研究特征所有试验参与者都是成年人,平均年龄从25.7岁到36.7岁。妇女的比例从15%到82%不等。试验持续了一到四周。在五项报告隐形眼镜不适的试验中,我们判断有三个高风险的偏见,并认为其他两个人有一些偏见的风险。润滑滴剂(包括盐水)与未治疗相比润滑滴剂与未治疗相比可减少隐形眼镜的不适,以37点刻度测量(越低越好),但证据非常不确定(平均差[MD]-5.9分,95%置信区间[CI]-3.74至-8.05;2项随机对照试验;119名参与者)。一项试验发现,在“日终”舒适度方面,润滑滴剂和不治疗之间没有区别。比较盐水与不治疗的试验未提供对照组的结果。两项研究在0至20的范围内测量了角膜荧光素染色(越低越好)。我们发现,低确定性的证据表明,润滑滴剂和未处理的变化程度之间几乎没有差异(MD-0.15分,95%CI-0.86至0.56;2项RCT;119名参与者),深度(MD-0.01分,95%CI-0.44至0.42;2项RCT;119名参与者),或类型(MD0.04分,95%CI-0.38至0.46;2项随机对照试验;119名参与者)角膜荧光素染色评分。关于结膜红肿,在0到4的范围内测量(越低越好),在鼻区评分(MD0.10,95%CI-0.29~0.49;1例RCT;73例参与者)和时间区评分(MD0.00,95%CI-0.39~0.39;1例RCT;73例参与者)方面,有低确定性证据表明润滑滴剂与未治疗之间几乎没有差异.没有研究报告微生物性角膜炎或炎性角膜浸润,在治疗4周内,没有试验报告出现威胁视力的不良事件.所有试验都报告了停止参与的参与者的比例。在两次审判中,没有参与者离开任何治疗组.我们对另外两项研究的荟萃分析表明,与未治疗组相比,退出润滑治疗组的人数差异不大(风险比[RR]1.42,95%CI0.19至10.94;138名参与者;低确定性证据)。润滑滴剂与生理盐水对比润滑滴剂与生理盐水相比,对视觉模拟量表为0至100(越低越好)的隐形眼镜不适几乎没有影响。但是证据非常不确定(MD9.5分,95%CI-4.65至23.65;1例RCT;39例参与者)。没有研究报告角膜荧光素染色或结膜发红。没有研究报告微生物性角膜炎或炎性角膜浸润,在治疗4周内,没有试验报告出现威胁视力的不良事件.我们对三项研究的荟萃分析表明,与生理盐水组相比,退出润滑治疗组的人数差异不大(RR1.56,95%CI0.47至5.12;269名参与者;低确定性证据)。
结论:非常低的确定性证据表明,与不治疗相比,润滑滴剂可以改善隐形眼镜的不适感,但与生理盐水相比,可能对隐形眼镜的不适影响很小或没有影响。低确定性的证据还表明,润滑滴可能不会产生不必要的影响,从而导致在一到四周内停药。目前的证据表明,向隐形眼镜不适的人开具润滑滴剂(包括生理盐水)是可行的选择。然而,大多数研究未使用经过验证的仪器评估患者报告的隐形眼镜(dis)舒适度.因此,需要进一步精心设计的试验,以产生关于患者报告结局以及长期安全性结局的高确定性证据.
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.
OBJECTIVE: To evaluate the efficacy and safety of lubricating drops for ocular discomfort associated with contact lens wear in adults.
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.
METHODS: 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.
METHODS: 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.
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).
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.