Ng Sueko M, Leslie Louis, Tzang Chih-Chen, Algarni Abdullah M, Kuo Irene C, Lawrenson Annali L
Department of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
School of Medicine, National Taiwan University, Taipei, Taiwan.
Cochrane Database Syst Rev. 2025 Sep 29;9(9):CD014617. doi: 10.1002/14651858.CD014617.pub3.
Corneal abrasion is a condition frequently treated by eye care professionals, emergency physicians, and primary care physicians. Topical ophthalmic antibiotics are the most common therapy for corneal abrasion. However, there has been no comprehensive summary and synthesis of the evidence regarding antibiotic prophylaxis in traumatic corneal abrasion. In this review update, we evaluated the current evidence regarding the benefits and harms of antibiotic treatment for this relatively common emergency condition. This is an update of a review published in 2022.
To assess the benefits and harms of topical antibiotic prophylaxis for corneal abrasion.
We searched CENTRAL, MEDLINE, Embase.com, two other databases, and two trials registries together with reference checking to identify studies that are included in the review. The latest search date was 28 March 2025.
We included randomized controlled trials (RCTs) comparing an antibiotic with another antibiotic or with placebo in children and adults with corneal abrasion(s).
Outcomes included the following: risk of any ocular infection up to one month following corneal abrasion, proportion of eyes healed within 48 hours, participant-reported pain intensity reduction of 50% or more at 24 hours, loss of one or more lines of best-corrected visual acuity at one month, change in pain interference from baseline to 24 hours, complications of corneal abrasion, and treatment-related adverse events at the longest follow-up.
Using the Cochrane risk of bias (RoB) 2 tool, we assessed the RoB for the three reported outcomes.
We synthesized results for each outcome using meta-analysis by calculating risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes where possible; otherwise, we summarized the results narratively. We used GRADE to assess the certainty of evidence for prespecified outcomes.
We included four RCTs enrolling a total of 998 participants, ranging from 20 to 437 participants. The included studies were published from 1975 to 1998, and conducted in Denmark (1), the Republic of Korea (1), and the UK (2). The length of follow-up was 24 hours to four weeks, or unspecified in two studies. Two studies had industry support. Participants had a mean age of 35 years (range 5 to 80 years) in one study, while the other three studies reported age ranges from 15 to 64 years. Most participants had traumatic corneal abrasions, commonly following foreign body removal. Two studies compared topical antibiotics with placebo (vehicle ointment or sodium hyaluronic acid drops), while three studies compared chloramphenicol ointment with antibiotics from other classes. One study was a three-arm study that compared two antibiotic regimens and one vehicle control. We judged the risk of bias from one study as raising some concerns about two efficacy outcomes, and three studies as having a high risk of overall bias across three outcomes.
We classified study interventions into two comparisons: 1) antibiotics versus placebo, and 2) chloramphenicol versus other classes of antibiotics. Overall, we judged the certainty of evidence as very low for all outcomes due to imprecision, indirectness, and risk of bias. Two studies compared antibiotics with placebo. For one study, we combined the data for the sulfacetamide sodium and chloramphenicol ointment groups and compared them with a vehicle control group in a three-arm study. This study suggested that antibiotics may increase the risk of ocular infection (RR 1.32, 95% CI 1.03 to 1.70; 1 study, 320 participants). The same study found little to no difference in healing within 48 hours (RR 0.94, 95% CI 0.88 to 1.00). Another study compared tobramycin with sodium hyaluronic acid and reported complete healing in most eyes by 48 hours, with no incidence of infection; however, the study was not included in the meta-analysis because of unit-of-analysis issues. One study reported severe allergic reactions to medication or other adverse events leading to participant withdrawal. The analysis showed no evidence of a difference in treatment-related adverse events between antibiotics and placebo (RR 0.77, 95% CI 0.40 to 1.47; 1 study, 437 participants). Another study reported no adverse events in both arms but was not included in the analysis because it was unclear how the outcomes were measured. Three studies compared chloramphenicol with other classes of antibiotics (fusidic acid or sulfacetamide sodium). The pooled analysis showed little to no difference in the risk of ocular infection within one month (RR 1.07, 95% CI 0.87 to 1.31; 3 studies, 651 participants). One study reported no positive cultures in either group, although minor inflammatory signs (e.g. conjunctival hyperemia) were noted in the chloramphenicol arm. For corneal healing within 48 hours, three studies assessed cure rates within 24 hours using slightly different definitions, but the pooled analysis again showed no clinically meaningful difference between groups (RR 1.00, 95% CI 0.94 to 1.06; 3 studies, 651 participants). Two studies found no evidence of a difference in the incidence of treatment-related adverse events between groups (RR 1.01, 95% CI 0.47 to 2.17; 2 studies, 677 participants). Another study reported that one-third of participants in both groups experienced discomfort or itching, although these outcomes were not reported separately by each treatment arm. For both comparisons, none of the included studies reported the following prespecified outcomes: participant-reported pain intensity reduction of 50% or more at 24 hours, loss of one or more lines of best-corrected visual acuity at one month, change in pain interference from baseline to 24 hours, and complications of corneal abrasion up to the longest follow-up.
AUTHORS' CONCLUSIONS: Given that the evidence supporting antibiotic use in corneal abrasion is of very low certainty, we are not able to support a specific antibiotic regimen or draw conclusions about the effects of antibiotic prophylaxis in preventing ocular infection or accelerating epithelial healing. Future research could explore adequately powered RCTs or alternative approaches, such as target trial emulation, while focusing on high-risk populations and antibiotic formulations.
The Cochrane Eyes and Vision US Project is supported by grant UG1EY020522, National Eye Institute, National Institutes of Health.
Protocol (2021) DOI: 10.1002/14651858.CD014617 Original Review (2022) DOI: 10.1002/14651858.CD014617.pub2.
角膜擦伤是眼科护理专业人员、急诊科医生和初级保健医生经常治疗的病症。局部眼科抗生素是治疗角膜擦伤最常用的疗法。然而,目前尚无关于创伤性角膜擦伤抗生素预防的证据的全面总结和综合分析。在本次综述更新中,我们评估了目前关于这种相对常见的紧急情况抗生素治疗的益处和危害的证据。这是对2022年发表的一篇综述的更新。
评估局部抗生素预防角膜擦伤的益处和危害。
我们检索了Cochrane系统评价数据库(CENTRAL)、医学期刊数据库(MEDLINE)、Embase.com、另外两个数据库以及两个试验注册库,并进行参考文献核对,以确定纳入综述的研究。最新检索日期为2025年3月28日。
我们纳入了将抗生素与另一种抗生素或安慰剂进行比较的随机对照试验(RCT),试验对象为患有角膜擦伤的儿童和成人。
结局指标包括以下内容:角膜擦伤后1个月内任何眼部感染的风险、48小时内愈合的眼睛比例、参与者报告在24小时时疼痛强度降低50%或更多、1个月时最佳矫正视力下降1行或更多行、从基线到24小时疼痛干扰的变化、角膜擦伤的并发症以及最长随访期的治疗相关不良事件。
我们使用Cochrane偏倚风险(RoB)2工具评估了三个报告结局的偏倚风险。
我们通过荟萃分析对每个结局的结果进行综合,尽可能计算二分结局的风险比(RR)及95%置信区间(CI);否则,我们对结果进行叙述性总结。我们使用GRADE评估预设结局证据的确定性。
我们纳入了4项RCT,共998名参与者,每项研究的参与者人数在20至437人之间。纳入的研究发表于1975年至1998年,分别在丹麦(1项)、韩国(1项)和英国(2项)进行。随访时间为24小时至4周,两项研究未明确说明。两项研究有行业资助。一项研究中参与者的平均年龄为35岁(范围为5至80岁),而其他三项研究报告的年龄范围为15至64岁。大多数参与者患有创伤性角膜擦伤,常见于异物取出后。两项研究将局部抗生素与安慰剂(赋形剂软膏或透明质酸钠滴眼液)进行比较,三项研究将氯霉素软膏与其他类别的抗生素进行比较。一项研究是三臂研究,比较了两种抗生素方案和一种赋形剂对照。我们判断一项研究的偏倚风险对两个疗效结局存在一些担忧,三项研究在三个结局方面存在总体偏倚的高风险。
我们将研究干预分为两组比较:1)抗生素与安慰剂,2)氯霉素与其他类抗生素。总体而言,由于不精确性、间接性和偏倚风险,我们判断所有结局的证据确定性都非常低。两项研究将抗生素与安慰剂进行比较。对于一项研究,我们在一项三臂研究中合并了磺胺醋酰钠和氯霉素软膏组的数据,并将其与赋形剂对照组进行比较。这项研究表明抗生素可能会增加眼部感染的风险(RR 1.32,95%CI 1.03至1.70;1项研究,320名参与者)。同一研究发现48小时内愈合情况几乎没有差异(RR 0.94,95%CI 0.88至1.00)。另一项研究将妥布霉素与透明质酸钠进行比较,报告大多数眼睛在48小时内完全愈合,无感染发生;然而,由于分析单位问题,该研究未纳入荟萃分析。一项研究报告了对药物的严重过敏反应或导致参与者退出的其他不良事件。分析显示抗生素与安慰剂在治疗相关不良事件方面没有差异的证据(RR 0.77,95%CI 0.40至1.47;1项研究,437名参与者)。另一项研究报告两组均无不良事件,但未纳入分析,因为不清楚结局是如何测量的。三项研究将氯霉素与其他类抗生素(夫西地酸或磺胺醋酰钠)进行比较。汇总分析显示1个月内眼部感染风险几乎没有差异(RR 1.07,95%CI 0.87至1.31;3项研究,651名参与者)。一项研究报告两组均无阳性培养结果,尽管氯霉素组出现了轻微炎症体征(如结膜充血)。对于48小时内角膜愈合情况,三项研究使用略有不同的定义评估了24小时内的治愈率,但汇总分析再次显示两组之间没有临床意义上的差异(RR 1.00,95%CI 0.94至1.06;3项研究,651名参与者)。两项研究发现两组在治疗相关不良事件发生率方面没有差异的证据(RR 1.01,95%CI 0.47至2.17;2项研究,677名参与者)。另一项研究报告两组中三分之一的参与者有不适或瘙痒感,尽管各治疗组未分别报告这些结局。对于这两组比较,纳入的研究均未报告以下预设结局:参与者报告在24小时时疼痛强度降低50%或更多、1个月时最佳矫正视力下降1行或更多行、从基线到24小时疼痛干扰的变化以及最长随访期的角膜擦伤并发症。
鉴于支持在角膜擦伤中使用抗生素的证据确定性非常低,我们无法支持特定的抗生素方案,也无法得出关于抗生素预防在预防眼部感染或加速上皮愈合方面效果的结论。未来的研究可以探索有足够样本量的RCT或替代方法,如目标试验模拟,同时关注高危人群和抗生素制剂。
Cochrane美国眼科与视觉项目由美国国立卫生研究院国家眼科研究所的UG1EY020522资助。
方案(2021)DOI:10.1002/14651858.CD014617 原始综述(2022)DOI:10.1002/14651858.CD014617.pub2