Corticosteroids for bacterial corneal ulcers.
OBJECTIVE
The aim of the study was to conduct a preliminary clinical trial to assess whether adjunctive topical corticosteroids improve outcomes in bacterial keratitis and, if no difference was found, to determine the feasibility and sample size necessary for conducting a larger trial to answer this question.


METHODS
In this single centre, double-masked clinical trial, 42 patients with culture-confirmed bacterial keratitis at Aravind Eye Hospital in India were randomised to receive either topical prednisolone phosphate or placebo. All patients received topical moxifloxacin. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months, adjusting for enrolment BSCVA and arm. Other pre-specified outcomes included re-epithelialisation time, infiltrate/scar size and adverse events.


RESULTS
Compared with placebo, patients in the steroid group re-epithelialised more slowly (hazard ratio 0.47, 95% CI 0.23 to 0.94). There was no significant difference in BSCVA or infiltrate/scar size at 3 weeks or 3 months. To have 80% power to detect a two-line difference in acuity, 360 cases would be required.


CONCLUSIONS
Although corticosteroid treatment resulted in a statistically significant delay in re-epithelialisation, this did not translate to a significant difference in visual acuity, infiltrate/scar size or adverse events. To assess the effect of steroids on acuity, a larger trial is warranted and feasible.
Srinivasan
M
M
Aravind Eye Care System, Madurai, India.
Lalitha
P
P
Mahalakshmi
R
R
Prajna
N V
NV
Mascarenhas
J
J
Chidambaram
J D
JD
Lee
S
S
Hong
K C
KC
Zegans
M
M
Glidden
D V
DV
McLeod
S
S
Whitcher
J P
JP
Lietman
T M
TM
Acharya
N R
NR
D000328:Adult; D000368:Aged; D003320:Corneal Ulcer / Q000188:drug therapy* / Q000382:microbiology / Q000503:physiopathology; D004311:Double-Blind Method; D019573:Epithelium, Corneal / Q000502:physiology; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000503:physiopathology; D005240:Feasibility Studies; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011239:Prednisolone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D014792:Visual Acuity / Q000187:drug effects; D014945:Wound Healing / Q000187:drug effects
D005938:Glucocorticoids; D009883:Ophthalmic Solutions; C009022:prednisolone phosphate; D011239:Prednisolone