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

Abstract

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.

• Authors: Muthiah Srinivasan, Jeena Mascarenhas, Revathi Rajaraman, Meenakshi Ravindran, Prajna Lalitha, David V Glidden, Kathryn J Ray, Kevin C Hong, Catherine E Oldenburg, Salena M Lee, Michael E Zegans, Stephen D McLeod, Thomas M Lietman, Nisha R Acharya, Steroids for Corneal Ulcers Trial Group
• Journal: Archives of ophthalmology (Chicago, Ill. : 1960) (Arch Ophthalmol) Vol. 130 Issue 2 Pg. 143-50 (Feb 2012) ISSN: 1538-3601 [Electronic] United States
• PMID: 21987582 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Infective Agents
• Aza Compounds
• Fluoroquinolones
• Glucocorticoids
• Quinolines
• prednisolone phosphate
• Prednisolone
• Moxifloxacin

Topics

• Administration, Topical
• Adult
• Anti-Infective Agents (therapeutic use)
• Aza Compounds (therapeutic use)
• Bacteria (isolation & purification)
• Cornea (microbiology)
• Corneal Ulcer (drug therapy, microbiology)
• Double-Blind Method
• Drug Therapy, Combination
• Eye Infections, Bacterial (drug therapy, microbiology)
• Female
• Fluoroquinolones
• Glucocorticoids (administration & dosage, therapeutic use)
• Humans
• Male
• Middle Aged
• Moxifloxacin
• Prednisolone (administration & dosage, analogs & derivatives, therapeutic use)
• Quinolines (therapeutic use)
• Treatment Outcome
• Visual Acuity