Bacterial keratitis is a serious ocular infectious disease that can
lead to severe visual disability. Risk factors for bacterial corneal
infection include contact lens wear, ocular surface disease, corneal trauma,
and previous ocular or eyelid surgery. Topical antibiotics constitute the
mainstay of treatment in cases of bacterial keratitis, whereas the use of
topical corticosteroids as an adjunctive therapy to antibiotics remains
controversial. Topical corticosteroids are usually used to control
inflammation using the smallest amount of the drug. Their use requires
optimal timing, concomitant antibiotics, and careful follow-up.
The objective of the review was to assess the effectiveness and
safety of corticosteroids as adjunctive therapy for bacterial keratitis.
Secondary objectives included evaluation of health economic outcomes and
quality of life outcomes.
We searched CENTRAL (which contains the Cochrane Eyes and Vision
Group Trials Register) (2014, Issue 6), Ovid MEDLINE, Ovid MEDLINE
In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid
OLDMEDLINE (January 1946 to July 2014), EMBASE (January 1980 to July 2014),
Latin American and Caribbean Health Sciences Literature Database (LILACS)
(January 1982 to July 2014), the metaRegister of Controlled
Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization
(WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or
language restrictions in the electronic searches for trials. We last
searched the electronic databases on 14 July 2014. We also searched the
Science Citation Index to identify additional studies that had cited the
only trial included in the original version of this review, reference lists
of included trials, earlier reviews, and the American Academy of
Ophthalmology guidelines. We also contacted experts to identify any
unpublished and ongoing randomized trials.
We included randomized controlled trials (RCTs) that had evaluated
adjunctive therapy with topical corticosteroids in people with bacterial
keratitis who were being treated with antibiotics.
Data collection and analysis
We used the standard methodological procedures expected by The
We found four RCTs that met the inclusion criteria of this review.
The total number of included participants was 611 (612 eyes), ranging from
30 to 500 participants per trial. One trial was included in the previous
version of the review, and we identified three additional trials through the
updated searches in July 2014. One of the three smaller trials was a pilot
study of the largest study: the Steroids for Corneal Ulcers Trial (SCUT).
All trials compared the treatment of bacterial keratitis with topical
corticosteroid and without topical corticosteroid and had follow-up periods
ranging from two months to one year. These trials were conducted in the USA,
Canada, India, and South Africa.
All trials reported data on visual acuity ranging from three weeks to
one year, and none of them found any important difference between the
corticosteroid group and the control group. The pilot study of the SCUT
reported that time to re-epithelialization in the steroid group was
53% slower than the placebo group after adjusting for baseline
epithelial defect size (hazard ratio (HR) 0.47; 95% confidence
interval (CI) 0.23 to 0.94). However, the SCUT did not find any important
difference in time to re-epithelialization (HR 0.92; 95% CI 0.76 to
1.11). For adverse events, none of the three small trials found any
important difference between the two treatment groups. The investigators of
the largest trial reported that more patients in the control group developed
intraocular pressure (IOP) elevation (risk ratio (RR) 0.20; 95% CI
0.04 to 0.90). One trial reported quality of life and concluded that there
was no difference between the two groups (data not available). We did not
find any reports regarding economic outcomes.
Although the four trials were generally of good methodological
design, all trials had considerable losses to follow-up (10% or
more) in the final analyses. Further, three of the four trials were
underpowered to detect treatment effect differences between groups and
inconsistency in outcome measurements precluded meta-analyses for most
outcomes relevant to this review.
There is inadequate evidence as to the effectiveness and safety of
adjunctive topical corticosteroids compared with no topical corticosteroids
in improving visual acuity, infiltrate/scar size, or adverse events among
participants with bacterial keratitis. Current evidence does not support a
strong effect of corticosteroid, but may be due to insufficient power to
detect a treatment effect.