Corticosteroids for bacterial keratitis: the Steroids for Corneal Ulcers Trial
(SCUT).
Author(s): 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;
Steroids for Corneal Ulcers Trial Group.
Collaborators: Srinivasan M, Lalitha P, Mascarenhas J, Prajna NV, Chandravathi
TS, Saravanan RS, Karpagam R, Rajkumar M, Mahalakshmi R, Ravindran M, Bharathi
MJ, Raj L, Meena M, Rajaraman R, Raghavan A, Manikandan P, Zegans ME,
Toutain-Kidd C, Miller D, Lietman TM, Acharya NR, McLeod SD, Whitcher JP, Lee SM,
Cevallos V, Oldenburg CE, Hong KC, Costanza S, Fisher M, Aldave A, Everett D,
Glover J, Kannan KA, Kymes S, Murthy GV, Schwab I, Lietman TM, Acharya NR,
Glidden DV, McLeod SD, Whitcher JP, Lee SM, Ray KJ, Cevallos V, Oldenburg CE,
Hong KC, Costanza S, Everett DF, Zegans ME, Kidd CM.
Affiliation(s): Departments of Cornea and External Diseases, Aravind Eye Care System, Madurai,
India.
Publication date & source: 2012, Arch Ophthalmol. , 130(2):143-50
OBJECTIVE: To determine whether there is a benefit in clinical outcomes with the
use of topical corticosteroids as adjunctive therapy in the treatment of
bacterial corneal ulcers.
METHODS: Randomized, placebo-controlled, double-masked, multicenter clinical
trial comparing prednisolone sodium phosphate, 1.0%, to placebo as adjunctive
therapy for the treatment of bacterial corneal ulcers. Eligible patients had a
culture-positive bacterial corneal ulcer and received topical moxifloxacin for at
least 48 hours before randomization.
MAIN OUTCOME MEASURES: The primary outcome was best spectacle-corrected visual
acuity (BSCVA) at 3 months from enrollment. Secondary outcomes included
infiltrate/scar size, reepithelialization, and corneal perforation.
RESULTS: Between September 1, 2006, and February 22, 2010, 1769 patients were
screened for the trial and 500 patients were enrolled. No significant difference
was observed in the 3-month BSCVA (-0.009 logarithm of the minimum angle of
resolution [logMAR]; 95% CI, -0.085 to 0.068; P = .82), infiltrate/scar size (P =
.40), time to reepithelialization (P = .44), or corneal perforation (P > .99). A
significant effect of corticosteroids was observed in subgroups of baseline BSCVA
(P = .03) and ulcer location (P = .04). At 3 months, patients with vision of
counting fingers or worse at baseline had 0.17 logMAR better visual acuity with
corticosteroids (95% CI, -0.31 to -0.02; P = .03) compared with placebo, and
patients with ulcers that were completely central at baseline had 0.20 logMAR
better visual acuity with corticosteroids (-0.37 to -0.04; P = .02).
CONCLUSIONS: We found no overall difference in 3-month BSCVA and no safety
concerns with adjunctive corticosteroid therapy for bacterial corneal ulcers.
APPLICATION TO CLINICAL PRACTICE: Adjunctive topical corticosteroid use does not
improve 3-month vision in patients with bacterial corneal ulcers.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00324168.
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