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Study Title and Description

Topical steroids in the treatment of central and paracentral corneal ulcers.



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 Topical steroids in the treatment of central and paracentral corneal ulcers.
Author Carmichael TR., Gelfand Y., Welsh NH.
Country Department of Ophthalmology, University of the Witwatersrand, Johannesburg, Republic of South Africa.
Year 1990
Numbers Pubmed ID: 2203467

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 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 of improved.
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2 Antibiotic-only General therapy on the day following admission with no additional corticosteroid therapy.
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Design Details
Question... Follow Up Answer Follow-up Answer
Page 528-31
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Study design RCT
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Number randomized Total: 40 eyes of 39 participants: 19 eyes to non-steroid group, 21 eyes to steroid group
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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
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Number analyzed Total analyzed for healing rates: 26 eyes: "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. Total analyzed for VA at 2 months: 28 eyes: 13 eyes in non-steroid group and 15 eyes in steroid
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Unit of analysis eye
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Losses to follow-up and reasons for loss to follow-up Total: 26: 14 eyes for healing rates and 12 eyes for VA
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How were missing data handled? excluded from analysis
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Reported power calculation no
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Any issues with study design? none
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Country South Africa
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Age (mean +/- SD) range 19 to 81 years; mean age was 51.4 years in non-steroid group and 51.6 years in steroid group
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Gender (male:female) 19:2 in the non-steroid group, 14:5 in the steroid group
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Inclusion criteria central or paracentral corneal ulcers severe enough to warrant admission to the hospital
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Exclusion criteria identification of fungal isolates, perforated ulcers, or descemetoceles, underlying viral corneal conditions, atopic ulcers; no light perception on admission; less than 13 years of age
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Equivalence of baseline characteristics no, there were fewer females in the steroid group; greater number of eyes in steroid group had paracentral ulcers (n = 14) compared with non-steroid group (n = 10); greater number of eyes in steroid group (n = 16) had hypopyon at admission compared with non-steroid group (n = 12)
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Antibiotic-only group general therapy on the day following admission with no additional corticosteroid therapy
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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
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Note
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Length of follow-up Planned: 18 months; Actual: VA outcome was only reported at 2 months
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Primary outcome, as defined in the study healing rate of ulcer
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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
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Secondary outcomes and measurements, as defined in the study VA: 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)
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Adverse events reported yes
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Intervals at which outcome were assessed VA was measured at 2 months; time points measured for healing rates were not specified
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Type of study published
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Study period not reported
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Source of funding not reported
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Declaration of interest not reported
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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 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
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Allocation concealment (selection bias):Authors' judgement Unclear risk
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Allocation concealment (selection bias):Support for judgement Not reported
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Masking of participants and personnel (performance bias):Authors' judgement High risk
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Masking of participants and personnel (performance bias):Support for judgement Study participants and personnel were not masked
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Masking of outcome assessment (detection bias):Authors' judgement High risk
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Masking of outcome assessment (detection bias):Support for judgement All assessments were conducted independently by 2 unmasked physicians
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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 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
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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
Outcome: Visual Acuity      Population: All Participants
Time Point Measure Antibiotic-steroid Antibiotic-only


2 months

N Analyzed 15 13
Counts
Outcome: Ulcer healing: rate      Population: All Participants
Time Point Measure Antibiotic-steroid Antibiotic-only


Not reported N/A

N Analyzed 15 11
Mean 0.36 mm²/day 0.30 mm²/day
SD
SE

Adverse Events
Arm or Total Title Description Number of Events Comments
Antibiotic-steroid Ocular adverse events One eye in each group experienced perforation, corneal thinning, and epithelial breakdown. 3
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Antibiotic-only 3
Total 6
Antibiotic-steroid Uncontrolled infection Two eyes in the control group.
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Antibiotic-only 2
Total 2
Antibiotic-steroid Recurrence of infection One eye in the corticosteroid group and two eyes in the control group had recurrence of hypopyon within one week of discharge after adequate treatment infection. 1
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Antibiotic-only 2
Total 3
Antibiotic-steroid Persistent epithelial defect Four eyes in the corticosteroid group and three eyes in the control group. 4
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Antibiotic-only 3
Total 7