title: The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial.
abstract: OBJECTIVE
  To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes.
  
  
  METHODS
  Randomized, placebo-controlled, double-masked clinical trial.
  
  
  METHODS
  This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis.
  
  
  RESULTS
  No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46).
  
  
  CONCLUSIONS
  Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species.
authors: Aravind Eye Care System, Madurai, India.
authors: Muthiah
authors: M
authors: Srinivasan
authors: Aravind Eye Care System, Madurai, India.
authors: Jeena
authors: J
authors: Mascarenhas
authors: Aravind Eye Care System, Coimbatore, India.
authors: Revathi
authors: R
authors: Rajaraman
authors: Aravind Eye Care System, Tirunelveli, India.
authors: Meenakshi
authors: M
authors: Ravindran
authors: Aravind Eye Care System, Madurai, India.
authors: Prajna
authors: P
authors: Lalitha
authors: Francis I. Proctor Foundation, University of California, San Francisco, California.
authors: Kieran S
authors: KS
authors: O'Brien
authors: Department of Epidemiology and Biostatistics, University of California, San Francisco, California.
authors: David V
authors: DV
authors: Glidden
authors: Francis I. Proctor Foundation, University of California, San Francisco, California.
authors: Kathryn J
authors: KJ
authors: Ray
authors: Francis I. Proctor Foundation, University of California, San Francisco, California.
authors: Catherine E
authors: CE
authors: Oldenburg
authors: Departments of Surgery (Ophthalmology) and Microbiology and Immunology, Dartmouth Medical School, Lebanon, New Hampshire.
authors: Michael E
authors: ME
authors: Zegans
authors: Francis I. Proctor Foundation, University of California, San Francisco, California.
authors: John P
authors: JP
authors: Whitcher
authors: Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California.
authors: Stephen D
authors: SD
authors: McLeod
authors: Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, California.
authors: Travis C
authors: TC
authors: Porco
authors: Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California.
authors: Thomas M
authors: TM
authors: Lietman
authors: Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. Electronic address: nisha.acharya@ucsf.edu.
authors: Nisha R
authors: NR
authors: Acharya
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001372:Aza Compounds / Q000627:therapeutic use*; D001419:Bacteria / Q000302:isolation & purification; D003320:Corneal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D024841:Fluoroquinolones; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077266:Moxifloxacin; D009615:Nocardia / Q000302:isolation & purification; D009617:Nocardia Infections / Q000188:drug therapy* / Q000382:microbiology; D009883:Ophthalmic Solutions; D011239:Prednisolone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011804:Quinolines / Q000627:therapeutic use*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000900:Anti-Bacterial Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D005938:Glucocorticoids; D009883:Ophthalmic Solutions; D011804:Quinolines; C009022:prednisolone phosphate; D011239:Prednisolone; D000077266:Moxifloxacin