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Study Title and Description

Comparison of antibiotic-only and antibiotic-steroid combination treatment in corneal ulcer patients: double-blinded randomized clinical trial.



Key Questions Addressed
1 What are the effects of topical corticosteroids as adjunctive therapy for bacterial keratitis?
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Primary Publication Information
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TitleData
Title Comparison of antibiotic-only and antibiotic-steroid combination treatment in corneal ulcer patients: double-blinded randomized clinical trial.
Author Blair J., Hodge W., Al-Ghamdi S., Balabanian R., Lowcock B., Pan YI., Sherif H., AlMahmoud T., Fergusson D., Slomovic A.
Country Department of Ophthalmology, University of Ottawa, Ottawa, Ont.
Year 2011
Numbers Pubmed ID: 21283156

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Topical corticosteroids as adjunctive therapy for bacterial keratitis 2014
Arms
Number Title Description Comments
1 Antibiotic-steroid Gatifoxacin 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."
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2 Antibiotic-only Gatifloxacin (Zymar, Allergan Inc, Irvine, Calif.) and a masked placebo.
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Design Details
Question... Follow Up Answer Follow-up Answer
Page 40-5
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Study design RCT
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Number randomized Total: 30: 15 in each group
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Exclusions after randomization and reasons for exclusion none
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Number analyzed Total: 26: 14 in the antibiotic only group, 12 in the antibiotic + steroid group
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Unit of analysis 1 eye per individual
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Losses to follow-up and reasons for loss to follow-up Total: 4: 1 in the antibiotic-only group, 3 in the antibiotic + steroid group. Reasons not reported
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How were missing data handled? excluded from analysis
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Reported power calculation yes: "In order to detect a difference of 4 mm² between groups with a standard deviation of 3.3 mm, a type I error of 0.05, and a power of 0.08, a crude sample size (2N) of 54 was calculated."
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Any issues with study design? none
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Country Canada
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Age (mean +/- SD) 40.7 +/- 21.12 years in the antibiotic-only group, 48.7 +/- 19.88 years in the antibiotic-steroid group
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Gender (male:female) 6:9 in the antibiotic-only group, 4:11 in the antibiotic-steroid group
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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 stain2. Involvement of only 1 eye3. Patients over the age of 12 years
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Exclusion criteria 1. Fungal, viral, or amoebic keratitis2. Known sensitivity or allergy to trial drugs3. Perforated ulcer4. Involvement of the only functional eye, with best corrected VA worse than 20/200 in the uninfected eye5. Use of topical or systemic steroids concurrently or within the past 2 months
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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)
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Antibiotic-only group gatifloxacin (Zymar, Allergan Inc, Irvine, Calif.) and a masked placebo
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Antibiotic-steroid group gatifloxacin and masked dexamethasone 0.1% (Maxidex, Alcon Inc, Fort Worth, Tex.)
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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."
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Length of follow-up Planned: 10 weeks; Actual: 10 weeks
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Primary outcome, as defined in the study reduction in ulcer size at 10 weeks compared with the baseline size
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Measurement of primary outcome in the study digital photographic measurement
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Secondary outcomes and measurements, as defined in the study Residual ulcer area by clinician estimateVA with a standard protocol illuminated ETDRS chartQuality of life by VF-14 scoreTime to healing
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Adverse events reported yes
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Intervals at which outcome were assessed all outcomes were reported at 10 weeks
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Type of study published
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Study period not reported
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Source of funding the Physicians' Services Incorporation Foundation, North York, Ontario
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Declaration of interest "The authors have no proprietary or commercial interest in any materials discussed in this article"
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Reported subgroup analyses none
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Age, median (25th to 75th percentile)
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General therapy
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Random sequence generation (selection bias):Authors' judgement Low risk
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Random sequence generation (selection bias):Support for judgement "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."
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Allocation concealment (selection bias):Authors' judgement Low risk
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Allocation concealment (selection bias):Support for judgement "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."
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Masking of participants and personnel (performance bias):Authors' judgement Low risk
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Masking of participants and personnel (performance bias):Support for judgement "Both the investigators and the patients were blinded to the treatment allocation."
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Masking of outcome assessment (detection bias):Authors' judgement Low risk
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Masking of outcome assessment (detection bias):Support for judgement "Two independent and blinded observers used validated software to precisely map ulcer areas. Theoretically, photographic measurement should be quite accurate."
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Incomplete outcome data (attrition bias):Authors' judgement High risk
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Incomplete outcome data (attrition bias):Support for judgement "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
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Selective reporting (reporting bias):Authors' judgement Unclear risk
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Selective reporting (reporting bias):Support for judgement Protocol was not available
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Other bias:Authors' judgement Low risk
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Other bias:Support for judgement No other bias identified
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Results & Comparisons


Results Data
Mean Difference P-Value
Outcome: Visual Acuity      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-only vs. Antibiotic-steroid


10 weeks

N Analyzed 12 14 0.42
Mean -0.31 -0.18 0.52
SD
SE
Mean Difference P-Value
Outcome: Ulcer healing: size      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-only vs. Antibiotic-steroid


10 weeks

N Analyzed 12 14
Mean -4.388 mm² -1.919 mm² 0.56
SD
SE
Mean Difference P-Value
Outcome: Quality of Life      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-only vs. Antibiotic-steroid


10 weeks

N Analyzed 12 14
Mean 9.7 6.2 0.42
SD
SE
Mean Difference P-Value
Outcome: Ulcer healing: size      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-only vs. Antibiotic-steroid


10 weeks

N Analyzed 12 14
Mean -4.206 mm² -0.789 mm² 0.05
SD
SE
Outcome: Ulcer healing: rate      Population: All Participants
Time Point Measure Antibiotic-steroid Antibiotic-only


Not reported N/A

N Enrolled 12 14
Counts 6 weeks 8 weeks
SD

Adverse Events
Arm or Total Title Description Number of Events Comments
Antibiotic-steroid Recurrence of ulcer One patient in both the antibiotic-steroid group and the control group. 1
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Antibiotic-only 1
Total 2