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Study Title and Description

Corticosteroids for bacterial keratitis: the Steroids for Corneal Ulcers Trial (SCUT).



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 Corticosteroids for bacterial keratitis: the Steroids for Corneal Ulcers Trial (SCUT).
Author Srinivasan M., Mascarenhas J., Rajaraman R., Ravindran M., Lalitha P., Glidden DV., Ray KJ., Hong KC., Oldenburg CE., Lee SM., Zegans ME., McLeod SD., Lietman TM., Acharya NR.
Country Departments of Cornea and External Diseases, Aravind Eye Care System, Madurai, India.
Year 2012
Numbers Pubmed ID: 21987582

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 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.
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2 Antibiotic-only Placebo, after a cornea culture that tested positive for bacteria and after they had received 48 hours of topical moxifloxacin.
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Design Details
Question... Follow Up Answer Follow-up Answer
Page 143-150
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Study design RCT
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Number randomized Total: 500: 250 to each group
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Exclusions after randomization and reasons for exclusion None
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Number analyzed Total: 442: 220 in the placebo group and 222 in the corticosteroid 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: 58: 30 patients (12.0%) in the placebo group and 28 patients (11.2%) in the corticosteroid group
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How were missing data handled? excluded from analysis
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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
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Any issues with study design? none
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Country India, USA
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Age (mean +/- SD)
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Gender (male:female) 147:103 in the placebo group, 126:124 in the corticosteroid group
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Inclusion criteria 1. Evidence of a corneal ulcer 2. Presence of bacteria on blood or chocolate agar culture 3. Antibiotic given for greater than or equal to 48 hours 4. The patient must be able to verbalize a basic understanding of the study after it is explained to the patient, as determined by physician examiner. This understanding must include a commitment to return for follow-up visits 5. Appropriate consent
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Exclusion criteria 1. Overlying epithelial defect < 0.75 mm at its greatest width at presentation 2. Corneal perforation or impending perforation 3. Evidence of fungus on KOH or Giemsa stain or on culture 4. Evidence of acanthamoeba by stain 5. Evidence of herpetic keratitis by history or examination 6. Corneal scar not easily distinguishable from current ulcer 7. Use of a topical steroid in the affected eye during the course of the present ulcer, including use after the symptoms of the ulcer started but before presentation 8. Use of systemic prednisolone during the course of the present ulcer 8. Age < 16 years (before 16th birthday) 9. Bilateral ulcers 10. Previous penetrating keratoplasty 12. Pregnancy (by history or urine test) 13. Outside 4-hour geographical radius for UCSF and Dartmouth 14. Outside 200 km radius for Aravind 15. Immediate steroid use necessary owing to surgery or other condition 16. Best spectacle-corrected vision < 6/60 in the fellow eye 17. Known allergy to study medications (steroid or preservative) 18. No light perception in the affected eye
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Equivalence of baseline characteristics yes
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Antibiotic-only group placebo, after a cornea culture that tested positive for bacteria and after they had received 48 hours of topical moxifloxacin
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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
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Note
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Length of follow-up Planned: 12 months; Actual: 12 months (follow-up ongoing)
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Primary outcome, as defined in the study best corrected visual acuity (BCVA) at 3 months from enrollment
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Measurement of primary outcome in the study tumbling E chart
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Secondary outcomes and measurements, as defined in the study BCVA at 3 weeks from enrollment; Infiltrate/scar size at 3 weeks and 3 months measured by slit lamp examination; Rate of adverse events, including corneal perforation; Time to re-epithelialization
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Adverse events reported yes
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Intervals at which outcome were assessed baseline, every 3 days +/- 1 day until re-epithelialization, at 3 weeks, and at 3 months
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Type of study published
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Study period 1 September 2006 to 22 February 2010
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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."
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Declaration of interest "None of the authors have any financial disclosures to report"
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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)"
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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
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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 "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."
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Allocation concealment (selection bias):Authors' judgement Unclear risk
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Allocation concealment (selection bias):Support for judgement Allocation concealment was not reported
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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 "Double-masking was achieved because the prednisolone phosphate solution was identical to placebo. Only the study biostatisticians were unmasked."
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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 "Double-masking was achieved because the prednisolone phosphate solution was identical to placebo. Only the study biostatisticians were unmasked."
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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 30 (12.0%) in the placebo group and 28 (11.2%) in the corticosteroid group were not included in the analysis
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Selective reporting (reporting bias):Authors' judgement Low risk
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Selective reporting (reporting bias):Support for judgement All pre-specified outcomes in the ClinicalTrials.gov record were reported in the full-length publications
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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
Outcome: Visual Acuity      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-steroid vs. Antibiotic-only


3 months

N Analyzed Mean Difference
Mean 95% CI low
SD 95% CI high
SE P-Value


12 months

N Analyzed 222 220 Mean Difference -0.04
Mean 95% CI low -0.12
SD 95% CI high 0.05
SE P-Value 0.39
Outcome: Visual Acuity      Population: Nocardia infection Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-steroid vs. Antibiotic-only


12 months

N Analyzed Mean Difference 0.18
Mean 95% CI low -0.04
SD 95% CI high 0.41
SE P-Value 0.16
Outcome: Visual Acuity      Population: No Nocardia infection Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-steroid vs. Antibiotic-only


12 months

N Analyzed Mean Difference -0.10
Mean 95% CI low -0.19
SD 95% CI high -0.02
SE P-Value 0.02
Outcome: Ulcer healing: size      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-steroid vs. Antibiotic-only


3 weeks

N Analyzed Mean Difference 0.05
Mean 95% CI low -0.09
SD 95% CI high 0.15
SE P-Value 0.60


3 months

N Analyzed Mean Difference 0.06
Mean 95% CI low -0.07
SD 95% CI high 0.17
SE P-Value 0.40


1 years

N Analyzed 222 220 Mean Difference 0.03
Mean 95% CI low -0.12
SD 95% CI high 0.18
SE P-Value 0.69
Outcome: Ulcer healing: size      Population: Nocardia infection Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-steroid vs. Antibiotic-only


1 years

N Analyzed Mean Difference 0.47
Mean 95% CI low 0.06
SD 95% CI high 0.88
SE P-Value 0.02
Outcome: Ulcer healing: rate      Population: All Participants Between-Arm Comparisons
Time Point Measure Antibiotic-steroid Antibiotic-only Comparison Measure Antibiotic-only vs. Antibiotic-steroid


Not reported N/A

N Enrolled 250 250 95% CI low 0.76
Counts 7.5 days 7 days 95% CI high 1.12
SD 1.02 0.79 Hazard Ratio (HR) 0.92
P-value 0.44

Adverse Events
Arm or Total Title Description Number of Events Comments
Antibiotic-steroid Serious adverse events No significant difference between groups (endophthalmitis, intraocular pressure > 35mmHg, and myocardial infarction or stroke): RR = 1.15 (95%CI: 0.56 to 2.37)
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Antibiotic-only
Total
Antibiotic-steroid Non-serious adverse events No significant difference between groups (no description of events): RR = 1.18 (95%CI: 0.77 to 1.79)
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Antibiotic-only
Total