Topical corticosteroids as adjunctive therapy for bacterial keratitis
References
References to studies included in this review
References to studies excluded from this review
References to ongoing studies
Additional references
References to other published versions of this review
Characteristics of studies
Characteristics of included studies [ordered by study ID]
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| Methods | Study design: RCT Number randomized: Total: 30 Per group: 15 Exclusions after randomization and reasons for exclusion: none Number analyzed: Total: 26 Per group: 14 in the antibiotic only group, 12 in the antibiotic + steroid group Unit of analysis: 1 eye per individual Losses to follow‐up and reasons for loss to follow‐up: Total: 4 Per group: 1 in the antibiotic‐only group, 3 in the antibiotic + steroid group Reasons not reported How were missing data handled?: excluded from analysis Any issues with study design?: none | |
| Participants | Country: Canada Age (mean ± SD): 40.7 ± 21.12 years in the antibiotic‐only group, 48.7 ± 19.88 years in the antibiotic‐steroid group Gender (male:female): 6:9 in the antibiotic‐only group, 4:11 in the antibiotic‐steroid group Inclusion criteria: 1. Bacterial corneal ulcer (defined as corneal epithelial defect and stromal inflammation of presumed bacterial origin) that was confirmed by culture or by bacteria seen on gram stain 2. Involvement of only 1 eye 3. Patients over the age of 12 years Exclusion criteria: 1. Fungal, viral, or amoebic keratitis 2. Known sensitivity or allergy to trial drugs 3. Perforated ulcer 4. Involvement of the only functional eye, with best corrected VA worse than 20/200 in the uninfected eye 5. Use of topical or systemic steroids concurrently or within the past 2 months Equivalence of baseline characteristics: no 1. History of cataract (yes:no): 0:15 in the antibiotic‐only group, 3:11 in the antibiotic‐steroid group (P value = 0.058 by Chi² test) 2. Visual acuity (logMAR) 0.53 in the antibiotic‐only group, 0.90 in the antibiotic‐steroid group (P value = 0.718 by Kruskal–Wallis test) | |
| Interventions | Antibiotic‐only group: gatifloxacin (Zymar, Allergan Inc, Irvine, Calif.) and a masked placebo Antibiotic‐steroid group: gatifloxacin and masked dexamethasone 0.1% (Maxidex, Alcon Inc, Fort Worth, Tex.) Note: "If the treating physician felt fortified antibiotics were necessary, the option of topical cefazolin 50 mg/ml and tobramycin 14 mg/ml, in place of gatifloxacin, was allowed." Length of follow‐up: Planned: 10 weeks Actual: 10 weeks | |
| Outcomes | Primary outcome, as defined in the study: reduction in ulcer size at 10 weeks compared with the baseline size Measurement of primary outcome in the study: digital photographic measurement Secondary outcomes and measurements, as defined in the study:
Adverse events reported: yes Intervals at which outcome were assessed: all outcomes were reported at 10 weeks | |
| Notes | Type of study: published Study period: not reported Source of funding: the Physicians' Services Incorporation Foundation, North York, Ontario Declaration of interest: "The authors have no proprietary or commercial interest in any materials discussed in this article" Reported subgroup analyses: none | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Stratified block randomization in blocks of 6 was used to force a reasonably equal number of eyes in the 2 groups. Randomization was stratified by ulcer size (<2 mm greatest diameter, 2–4 mm greatest diameter, or >4 mm greatest diameter) as ulcer size is an important confounder in this study." |
| Allocation concealment (selection bias) | Low risk | "The allocation schedule was generated by a central office using a computer algorithm from the uniform distribution (STATA Corp, College Station, Tex.). The generator of the random allocation did not participate in executing the intervention and the executors did not participate in generating the schedule." |
| Masking of participants and personnel (performance bias) | Low risk | "Both the investigators and the patients were blinded to the treatment allocation." |
| Masking of outcome assessment (detection bias) | Low risk | "Two independent and blinded observers used validated software to precisely map ulcer areas. Theoretically, photographic measurement should be quite accurate." |
| Incomplete outcome data (attrition bias) | High risk | "Primary analysis was performed based on an intent‐to‐treat scenario regardless of compliance or protocol deviations." Patients who were lost to follow‐up were not included for the analysis: 1 patient (6.7%) in the antibiotic‐only group and 3 patients (20%) in the antibiotic‐steroid group were lost to follow‐up. The reasons for loss to follow‐up were not reported |
| Selective reporting (reporting bias) | Unclear risk | Protocol was not available |
| Other bias | Low risk | No other bias identified |
| Methods | Study design: RCT Number randomized: Total: 40 eyes of 39 participants Per group: 19 eyes to non‐steroid group, 21 eyes to steroid group Exclusions after randomization and reasons for exclusion: 1 participant (1 eye) in the steroid group did not receive treatment due to descemetocele formation the morning after admission; another participant (1 eye) had corneal thinning with early descemetocele formation and steroids were discontinued after 12 days Number analyzed: Total analyzed for healing rates: 26 eyes Per group: "Healing rates were calculated with data available only for 15 eyes in steroid group and 11 eyes in non‐steroid group". Participants were excluded from analysis if they had persistent epithelial defects (more than 21 days), required therapy other than that in the protocol, such as pressure padding for perforations or corneal thinning and if they had uncontrolled infection that did not heal Per group: 13 eyes in non‐steroid group and 15 eyes in steroid group Unit of analysis: eye Losses to follow‐up: 14 eyes for healing rates and 12 eyes for VA How were missing data handled?: excluded from analysis Reported power calculation: no Any issues with study design?: none | |
| Participants | Country: South Africa Age: range 19 to 81 years; mean age was 51.4 years in non‐steroid group and 51.6 years in steroid group Gender (male:female): 19:2 in the non‐steroid group, 14:5 in the steroid group | |
| Interventions | Antibiotic‐only group: general therapy on the day following admission with no additional corticosteroid therapy Antibiotic‐steroid group: 0.1% dexamethasone eye drops 4 times a day were added to general therapy on the day following admission if the condition of the ulcer was adjudged to be the same or improved Length of follow‐up: Planned: 18 months Actual: VA outcome was only reported at 2 months | |
| Outcomes | Primary outcome: healing rate of ulcer Measurement of primary outcome in the study: each ulcer was drawn to scale onto a 1 mm ruled graph paper and the number of squares was counted to calculate the area for each ulcer at admission and to calculate the area of ulcer healed per day Measurement of secondary outcomes in the study: measured with Snellen charts at 2 months by 2 physicians independently (VA was categorized using an arbitrary scale to compare the improvement in the 2 treatment arms) Adverse events reported: yes Intervals at which outcome were assessed: VA was measured at 2 months; time points measured for healing rates were not specified | |
| Notes | Type of study: published Study period: not reported Source of funding: not reported Declaration of interest: not reported Reported subgroup analyses: none | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization was done using a random numbers table. The first case number was randomly selected, with odd numbers being allocated to one treatment group and even numbers to the other |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Masking of participants and personnel (performance bias) | High risk | Study participants and personnel were not masked |
| Masking of outcome assessment (detection bias) | High risk | All assessments were conducted independently by 2 unmasked physicians |
| Incomplete outcome data (attrition bias) | High risk | Total number analyzed was 26 out of 40 eyes (65%). Healing rates were calculated with data available only for 15 eyes in the steroid group and 11 eyes in the non‐steroid group. Analysis of visual acuity at 2 months included only 15 eyes in the steroid group and 13 eyes in the non‐steroid group |
| Selective reporting (reporting bias) | Unclear risk | Protocol was not available |
| Other bias | Low risk | No other bias identified |
| Methods | Study design: RCT Number randomized: Total: 500 Per group: 250 Exclusions after randomization and reasons for exclusion: Total: none Per group: none Number analyzed: Total: 442 Per group: 220 in the placebo group; 222 in the corticosteroid group Unit of analysis: 1 eye per individual Losses to follow‐up and reasons for loss to follow‐up: Total: 58 Per group: 30 patients (12.0%) in the placebo group, 28 patients (11.2%) in the corticosteroid group How were missing data handled?: excluded from analysis Reported power calculation: yes: a sample size of 500 participants (250 per arm) can provide 80% power to detect a 0.20 logMAR (2 lines of visual acuity) difference between groups in BCVA 3 months after enrollment, assuming a SD of 0.65 logMAR for 3‐month BCVA Any issues with study design?: none | |
| Participants | Country: India, USA Age, median (25th to 75th percentile): 54.5 (40.0 to 61.0) in the placebo group, 52.0 (40.0 to 62.0) in the corticosteroid group, 53.0 (40.0 to 61.0) in total Gender (male:female): 147:103 in the placebo group, 126:124 in the corticosteroid group Inclusion criteria:
Exclusion criteria:
Equivalence of baseline characteristics: yes | |
| Interventions | Antibiotic‐only group: placebo, after a cornea culture that tested positive for bacteria and after they had received 48 hours of topical moxifloxacin Antibiotic‐steroid group: topical prednisolone sodium phosphate 1.0% after a cornea culture that tested positive for bacteria and after they had received 48 hours of topical moxifloxacin Length of follow‐up: Planned: 12 months Actual: 12 months (follow‐up ongoing) | |
| Outcomes | Primary outcome, as defined in the study: best corrected visual acuity (BCVA) at 3 months from enrollment Measurement of primary outcome in the study: tumbling E chart Secondary outcomes and measurements, as defined in the study:
Adverse events reported: yes Intervals at which outcome were assessed: baseline, every 3 days ± 1 day until re‐epithelialization, at 3 weeks, and at 3 months | |
| Notes | Type of study: published Study period: 1 September 2006 to 22 February 2010 Source of funding: "The trial was funded by National Eye Institute grant U10 EY015114 (Dr Lietman). Dr Acharya is supported by National Eye Institute grant K23 EY017897 and a Research to Prevent Blindness Award. Alcon/Novartis AG provided moxifloxacin (Vigamox) for the trial. The Department of Ophthalmology at the University of California, San Francisco, is supported by core grant EY02162 from the National Eye Institute." Declaration of interest: "None of the authors have any financial disclosures to report" Reported subgroup analyses: "Prespecified subgroups included baseline BCVA (<20/40, 20/40 to 20/800, and counting fingers or worse), geometric mean of baseline infiltrate/scar size (0‐1.90, 1.91‐2.70, 2.71‐4.06, and 4.07‐8.90 mm), infiltrate depth (>0%‐33%, >33%‐ 67%, and >67%‐100%), and ulcer location (completely filling the 4‐mm central artificial pupil, partially filling the 4‐mm central pupil, and entirely in the periphery)" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Participants were randomized in a 1:1 ratio either to placebo drops or prednisolone phosphate drops using permuted blocks within study centers. Block sizes were randomized in sizes of 4, 6, and 8." |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not reported |
| Masking of participants and personnel (performance bias) | Low risk | "Double‐masking was achieved because the prednisolone phosphate solution was identical to placebo. Only the study biostatisticians were unmasked." |
| Masking of outcome assessment (detection bias) | Low risk | "Double‐masking was achieved because the prednisolone phosphate solution was identical to placebo. Only the study biostatisticians were unmasked." |
| Incomplete outcome data (attrition bias) | High risk | 30 (12.0%) in the placebo group and 28 (11.2%) in the corticosteroid group were not included in the analysis |
| Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes in the ClinicalTrials.gov record were reported in the full‐length publications |
| Other bias | Low risk | No other bias identified |
| Methods | Study design: RCT Number randomized: Total: 42 participants Per group: 22 in the placebo group and 20 in the steroid group Exclusions after randomization and reasons for exclusion: none Number analyzed: Total: 33 participants Per group: 17 in the placebo group and 16 in the steroid group for analysis of best spectacle‐corrected visual acuity at 3 months Unit of analysis: 1 eye per individual Losses to follow‐up and reasons for loss to follow‐up: at week 3, 5 participants in the placebo group and 1 participant in the steroid group discontinued intervention; at month 3, an additional 5 participants in the placebo group and 4 participants in the steroid group discontinued intervention; reasons for discontinuation were not specified How were missing data handled?: excluded from analysis Reported power calculation: yes: 42 participants (21 participants per arm) can provide 80% power to detect a 0.4 logMAR (4 Snellen lines) difference between the 2 study arms, assuming a SD of 0.4 in the 3‐month BCVA Any issues with study design?: none | |
| Participants | Country: India | |
| Interventions | Antibiotic‐only group: adjunctive placebo, 0.9% sodium chloride, administered topically to the cornea 4 times a day for 1 week, followed by 2 times a day for 1 week, then once a day for 1 week and then stopped Antibiotic‐steroid group: adjunctive topical corticosteroids, topical prednisolone phosphate 1% administered topically to the cornea 4 times a day for 1 week, followed by 2 times a day for 1 week, then once a day for 1 week and then stopped Length of follow‐up: Planned: 3 weeks and 3 months after enrollment Actual: 3 weeks and 3 months after enrollment | |
| Outcomes | Primary outcome, as defined in the study: best corrected visual acuity (BCVA) at 3 months, adjusting for enrolment BCVA and group Measurement of primary outcome in the study: BCVA at 3 months in the study eye, using a linear regression model with 3‐month logMAR BCVA as the outcome variable and treatment arm (placebo versus steroid) and enrolment logMAR BCVA as covariates Secondary outcomes, as defined in the study: re‐epithelialization time, infiltrate/scar size, and adverse events Measurement of secondary outcomes in the study: BCVA at 3 weeks, adjusting for enrolment BCVA, and infiltrate/scar size at 3 weeks and 3 months, adjusting for enrolment infiltrate/scar size. For analysis, infiltrate/scar size was characterized by the geometric mean of the longest dimension and the longest perpendicular. The association between enrolment and 3‐month BCVA was assessed using Pearson’s correlation coefficient Adverse events reported: yes Intervals at which outcome were assessed: 3 weeks and 3 months after the enrollment | |
| Notes | Type of study: published Study period: 4 January 2005 to 20 August 2005 Source of funding: That Man May See and the South Asia Research Fund. The Department of Ophthalmology at UCSF is supported by a core grant from the National Eye Institute, EY02162. N Acharya is supported by a National Eye Institute K23EY017897 grant and a Research to Prevent Blindness Career Development Award. TM Lietman is supported by a National Eye Institute grant U10‐EY015114 and a Research to Prevent Blindness award. M Zegans is supported by a K08 EY13977‐01 NEI grant Declaration of interest: "None declared. Alcon donated moxifloxacin for the study. The sponsors had no role in the design or conduct of the study, data analysis or manuscript preparation. None of the authors have any financial disclosures related to this manuscript." Reported subgroup analyses: none | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization was done using "block randomisation in groups of ten generated by RAND command in Excel by TML; implementation including enrolment and assignment of participants by RM." |
| Allocation concealment (selection bias) | Unclear risk | Did not describe explicitly; stated only that after a minimum of 48 hours of moxifloxacin treatment, patients were randomized (block randomization in groups of 10 generated by RAND command in Excel by TML; implementation including enrolment and assignment of participants by RM) to receive topical prednisolone phosphate 1% or placebo drops |
| Masking of participants and personnel (performance bias) | Low risk | "Double‐masking of treatment assignment was achieved since the prednisolone phosphate solution could not be differentiated from the placebo. All study‐site personnel and patients were masked to treatment assignment. Only the biostatisticians responsible for the randomisation coding and the study pharmacist were unmasked." |
| Masking of outcome assessment (detection bias) | Low risk | "Double‐masking of treatment assignment was achieved since the prednisolone phosphate solution could not be differentiated from the placebo. All study‐site personnel and patients were masked to treatment assignment. Only the biostatisticians responsible for the randomisation coding and the study pharmacist were unmasked." |
| Incomplete outcome data (attrition bias) | High risk | "Efficacy endpoints were analysed on an intent‐to‐treat basis for all randomised patients enrolled in the study. The primary analysis included patients with both enrolment and 3‐month data. A sensitivity analysis was also performed in which 3‐week values were carried forward to 3 months if the 3‐month visit was missed." "Forty‐two patients with culture‐proven BK at Aravind Eye Hospital were enrolled: 22 in the placebo arm and 20 in the steroid arm. Thirty‐three patients (79%) were followed‐up at 3 months, and an additional three patients were followed‐up at their 3‐weeks but missed their 3‐month visit." |
| Selective reporting (reporting bias) | Low risk | We did not have access to the reported outcomes with the original study protocol. We assessed the selective outcome reporting by comparing the reported outcomes in the methods and results sections. Also, because this is the pilot trial for the SCUT trial, and the SCUT trial has a protocol, we compared these 2 studies and they have similarly reported all expected outcomes |
| Other bias | Low risk | No other bias identified |
BCVA: best corrected visual acuity
ETDRS: Early Treatment Diabetic Retinopathy Study
g/l: grams per liter
KOH: potassium hydroxide
mg: milligrams
mm: millimeters
RCT: randomized controlled trial
SD: standard deviation
VA: visual acuity
Characteristics of excluded studies [ordered by study ID]
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| Study | Reason for exclusion |
| Not relevant to bacterial keratitis | |
| Non‐comparative case report | |
| Review article; no new randomized trial described | |
| Not RCT and not relevant to bacterial keratitis | |
| Not RCT; amniotic membrane transplantation is not one of the interventions in the inclusion criteria | |
| Case report | |
| Case report | |
| Not RCT; no clear mention of inclusion of bacterial keratitis | |
| Cohort study | |
| Cross‐sectional study | |
| Retrospective study | |
| Inclusion criteria do not include bacterial keratitis | |
| Retrospective study | |
| Review article; no new randomized trial described | |
| Abstract only; no full length publication available |
RCT: randomized controlled trial
Characteristics of ongoing studies [ordered by study ID]
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| Trial name or title | Antibiotic Steroid Combination Compared With Individual Administration in the Treatment of Ocular Inflammation and Infection |
| Methods | Study design: interventional, randomized, parallel‐group design, double‐blinded (participant, investigator) trial Expected number to be randomized: Total: 60 participants Per group: 30 participants Unit of analysis: 1 eye per individual Reported power calculation: not reported |
| Participants | Country: Brazil Age: eligibility is 18 years and older Gender (male:female): the study has not yet recruited participants, but plan to recruit both genders |
| Interventions | Intervention 1: fixed combination of azithromycin 1.5%/loteprednol 0.5% eye drops + placebo eye drops Intervention 2: azithromycin 1.5% + loteprednol 0.5% eye drops (separately) |
| Outcomes | Primary outcome measures: "clinical cure achieved when the score of the cardinal ocular signs (hyperemia in the bulbar conjunctiva, palpebral, exudate / conjunctival discharge, eyelid erythema and flaking / crust eyelid) is zero at the time of conclusion of the study" on day 8 Secondary outcome measures: eradication of pathogens defined as "success obtained with microbiological irradication of pathogens present at baseline" on day 8 Other outcome measures: "decrease of visual acuity, corneal/anterior chamber changes, IOP increase and adverse event reporting" on day 4 and day 8 |
| Starting date | December 2012 |
| Contact information | Cristina Muccioli, MD: 5511‐99748809; [email protected] Luci Silva, MBA: 5511‐71571967; [email protected] Locations: Brazil Department of Ophthalmology of Hospital São Paulo |
| Notes | Estimated study completion date: May 2013 The study had not yet recruited participants as of 5 November 2012 The study is sponsored by Adapt Produtos Oftalmológicos Ltda |
IOP: intraocular pressure
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Time to re‐epithelialization Show forest plot | 2 | Hazard Ratio (Fixed, 95% CI) | Totals not selected | |
| Analysis 1.1  Comparison 1 Steroid versus placebo for the treatment of corneal ulcers, Outcome 1 Time to re‐epithelialization. | ||||
Results from searching for studies for inclusion in the review
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1 Steroid versus placebo for the treatment of corneal ulcers, Outcome 1 Time to re‐epithelialization.
| Outcomes | |||||
| Visual acuity | Effect measure | Mean change in logMAR visual acuity from baseline, measured by ETDRS chart | Mean BCVA from Snellen chart and then converted to a numerical equivalent number; linear regression model | Mean difference in logMAR BCVA between groups from multiple linear regression model, using a protocol adapted from AREDS using a tumbling "E" chart | Mean logMAR BCVA adapted from AREDS using a tumbling "E" chart; mean difference in logMAR BCVA between groups from multiple linear regression model |
| Time point(s) measured | 10 weeks | 2 months | 3 weeks, 3 months, 12 months | 3 weeks and 3 months | |
| Estimate | Steroid group: ‐0.31 (SD or 95% CI not reported) Control group: ‐0.18 (SD or 95% CI not reported) | 1) Mean BCVA: Steroid group: mean pretreatment vision: 6; mean post‐treatment vision: 9.7 Non‐steroid group: mean pretreatment vision: 6.4; mean post‐treatment vision: 9.2 2) Linear regression model: linear regression showed no difference between groups | 3 weeks: steroid group had 0.024 better logMAR BCVA (95% CI ‐0.092 to 0.044) 3 months: steroid group had 0.009 better logMAR BCVA (95% CI ‐0.085 to 0.068) 12 months: steroid group had 0.04 better logMAR BCVA (95% CI ‐0.12 to 0.05) | 1) Mean (SD) logMAR BCVA: 3 weeks: steroid group: 0.66 (0.68); placebo group: 0.75 (0.75) 3 months: steroid group: 0.71 (0.72); placebo group: 0.59 (0.75) 2) Multiple linear regression model: 3 weeks: steroid group had 0.19 lower (better) logMAR BCVA (95% CI ‐0.52 to 0.15) 3 months: steroid group had 0.09 lower (better) logMAR BCVA (95% CI ‐0.41 to 0.24) | |
| Interpretation | No statistically significant difference between groups was found | No statistically significant difference between groups was found | No statistically significant difference between groups was found | No statistically significant difference between groups was found | |
| Healing rate/ulcer size /time to re‐epithelialization | Effect measure | Mean change in ulcer area from baseline (mm2), measured by photographic measurement and by clinician estimate (slit lamp) | Mean size of ulcer (mm2) healed per day, measured at the slit lamp | Mean difference in diameter of ulcer area from linear regression models, measured by a Haag‐Streit 900 slit lamp biomicroscope; median time to re‐epithelialization (days) | Mean difference in diameter of ulcer area from linear regression models, measured by a Haag‐Streit 900 slit lamp biomicroscope |
| Time point(s) measured | 10 weeks | 21 days | 3 weeks, 3 months, 12 months | 3 weeks and 3 months | |
| Estimate | Photographic measurement: Steroid group: ‐4.388 mm2 Control group: ‐1.919 mm2 (SD or 95% CI not reported) Clinician estimate (slit lamp): Steroid group: ‐4.206 mm2 Control group: ‐0.789 mm2 (SD or 95% CI not reported) | Steroid group: 0.36 mm2 per day Control group: 0.30 mm2 per day | Ulcer size: 3 weeks: steroid group had 0.05 mm smaller diameter of scar area (95% CI ‐0.09 to 0.15) 3 months: steroid group had 0.06 mm smaller diameter of scar area (95% CI ‐0.07 to 0.17) 12 months: steroid group had 0.03 mm smaller diameter of scar area (95% CI ‐0.12 to 0.18) Time to re‐epithelialization: Steroid group: 7.5 days (95% CI 5.5 to 8.5 days) Placebo group: 7 days (95% CI 5.5 to 8.5 days) | Ulcer size: 3 weeks: steroid group had 0.57 mm smaller diameter of scar area (95% CI 1.5 to 0.37) 3 months: steroid group had 0.33 mm smaller diameter of scar area (95% CI 1.4 to 0.75) Time to re‐epithelialization: steroid group: 8.6 days (SD 4.7) placebo group: 6.3 days (SD 3.1) | |
| Interpretation | No statistically significant difference between groups from photographic measurement; statistically significant difference between groups from clinician estimate | No statistically significant difference between groups was found | No statistically significant difference between groups was found | No statistically significant difference between groups was found | |
| AREDS: Age Related Eye Disease Study | |||||
| Adverse event | ||||||||||||
| Steroid | Control | RR (95% CI) | Steroid | Control | RR (95% CI) | Steroid | Placebo | RR (95% CI) | Steroid | Placebo | RR (95% CI) | |
| Recurrence of the ulcer | 1/14 | 0/12 | 2.60 (0.12 to 58.48) | 1/21 | 2/19 | 0.45 (0.04 to 4.60) | / | / | / | / | / | / |
| Second ulcer | 0/14 | 1/12 | 0.29 (0.01 to 6.50) | / | / | / | / | / | / | / | / | / |
| Corneal thinning | / | / | / | 1/21 | 1/19 | 0.90 (0.06 to 13.48) | 0/250 | 2/250 | 0.20 (0.01 to 4.14) | / | / | / |
| Corneal perforation | / | / | / | 1/21 | 1/19 | 0.90 (0.06 to 13.48) | 7/250 | 8/250 | 0.88 (0.32 to 2.38) | 0/20 | 2/22 | 0.20 (0.01 to 3.94) |
| Uncontrolled infection | / | / | / | 0/21 | 2/19 | 0.18 (0.01 to 3.56) | / | / | / | / | / | / |
| Persistent epithelial defect | / | / | / | 4/21 | 3/19 | 1.21 (0.31 to 4.71) | 44/250 | 27/250 | 1.63 (1.04 to 2.54) | / | / | / |
| Epithelial breakdown | / | / | / | 1/21 | 1/19 | 0.90 (0.06 to 13.48) | / | / | / | / | / | / |
| Death | / | / | / | / | / | / | 7/250 | 5/250 | 1.40 (0.45 to 4.35) | / | / | / |
| Systemic infection | / | / | / | / | / | / | 1/250 | 0/250 | 3.00 (0.12 to 73.29) | / | / | / |
| Increase in hypopyon | / | / | / | / | / | / | 4/250 | 4/250 | 1.00 (0.25 to 3.95) | / | / | / |
| IOP elevation | / | / | / | / | / | / | 2/250 | 10/250 | 0.20 (0.04 to 0.90) | 0/20 | 1/22 | 0.37 (0.02 to 8.48) |
| Worsening infiltrate | / | / | / | / | / | / | 9/250 | 4/250 | 2.25 (0.70 to 7.21) | 0/20 | 1/22 | 0.37 (0.02 to 8.48) |
| Other | / | / | / | / | / | / | 9/250 | 13/250 | 0.69 (0.30 to 1.59) | / | / | / |
| CI: confidence interval | ||||||||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Time to re‐epithelialization Show forest plot | 2 | Hazard Ratio (Fixed, 95% CI) | Totals not selected | |
