Sueko M Ng, Louis Leslie, Chih-Chen Tzang, Abdullah M Algarni, Irene C Kuo, Annali L Lawrenson
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This is an update of a review published in 2022.</p><p><strong>Objectives: </strong>To assess the benefits and harms of topical antibiotic prophylaxis for corneal abrasion.</p><p><strong>Search methods: </strong>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.</p><p><strong>Eligibility criteria: </strong>We included randomized controlled trials (RCTs) comparing an antibiotic with another antibiotic or with placebo in children and adults with corneal abrasion(s).</p><p><strong>Outcomes: </strong>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.</p><p><strong>Risk of bias: </strong>Using the Cochrane risk of bias (RoB) 2 tool, we assessed the RoB for the three reported outcomes.</p><p><strong>Synthesis methods: </strong>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.</p><p><strong>Included studies: </strong>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.</p><p><strong>Synthesis of results: </strong>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.</p><p><strong>Authors' conclusions: </strong>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.</p><p><strong>Funding: </strong>The Cochrane Eyes and Vision US Project is supported by grant UG1EY020522, National Eye Institute, National Institutes of Health.</p><p><strong>Registration: </strong>Protocol (2021) DOI: 10.1002/14651858.CD014617 Original Review (2022) DOI: 10.1002/14651858.CD014617.pub2.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"9 ","pages":"CD014617"},"PeriodicalIF":8.8000,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477753/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cochrane Database of Systematic Reviews","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/14651858.CD014617.pub3","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
Rationale: 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.
Objectives: To assess the benefits and harms of topical antibiotic prophylaxis for corneal abrasion.
Search methods: 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.
Eligibility criteria: We included randomized controlled trials (RCTs) comparing an antibiotic with another antibiotic or with placebo in children and adults with corneal abrasion(s).
Outcomes: 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.
Risk of bias: Using the Cochrane risk of bias (RoB) 2 tool, we assessed the RoB for the three reported outcomes.
Synthesis methods: 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.
Included studies: 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.
Synthesis of results: 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.
Funding: The Cochrane Eyes and Vision US Project is supported by grant UG1EY020522, National Eye Institute, National Institutes of Health.
Registration: Protocol (2021) DOI: 10.1002/14651858.CD014617 Original Review (2022) DOI: 10.1002/14651858.CD014617.pub2.
期刊介绍:
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