Document Detail


Corticosteroids for bacterial keratitis: the Steroids for Corneal Ulcers Trial (SCUT).
MedLine Citation:
PMID:  21987582     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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;
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2011-10-10
Journal Detail:
Title:  Archives of ophthalmology     Volume:  130     ISSN:  1538-3601     ISO Abbreviation:  Arch. Ophthalmol.     Publication Date:  2012 Feb 
Date Detail:
Created Date:  2012-02-14     Completed Date:  2012-04-13     Revised Date:  2013-12-11    
Medline Journal Info:
Nlm Unique ID:  7706534     Medline TA:  Arch Ophthalmol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  143-50     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00324168
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
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
Glucocorticoids / administration & dosage,  therapeutic use*
Humans
Male
Middle Aged
Prednisolone / administration & dosage,  analogs & derivatives*,  therapeutic use
Quinolines / therapeutic use*
Treatment Outcome
Visual Acuity
Grant Support
ID/Acronym/Agency:
EY02162/EY/NEI NIH HHS; K23 EY017897/EY/NEI NIH HHS; K23 EY017897/EY/NEI NIH HHS; U10 EY015114/EY/NEI NIH HHS; U10 EY015114/EY/NEI NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Infective Agents; 0/Aza Compounds; 0/Glucocorticoids; 0/Quinolines; 752SY38R6C/prednisolone phosphate; 9PHQ9Y1OLM/Prednisolone; U188XYD42P/moxifloxacin
Investigator
Investigator/Affiliation:
Muthiah Srinivasan / ; Prajna Lalitha / ; Jeena Mascarenhas / ; N Venkatesh Prajna / ; Thirukkonda Subramanian Chandravathi / ; R Somu Saravanan / ; Rajarathinam Karpagam / ; Malaiyandi Rajkumar / ; Rajendran Mahalakshmi / ; Meenakshi Ravindran / ; M Jayahar Bharathi / ; Lionel Raj / ; M Meena / ; Revathi Rajaraman / ; Anita Raghavan / ; P Manikandan / ; Michael E Zegans / ; Christine Toutain-Kidd / ; Donald Miller / ; Thomas M Lietman / ; Nisha R Acharya / ; Stephen D McLeod / ; John P Whitcher / ; Salena M Lee / ; Vicky Cevallos / ; Catherine E Oldenburg / ; Kevin C Hong / ; Stephanie Costanza / ; Marian Fisher / ; Anthony Aldave / ; Donald Everett / ; Jacqueline Glover / ; K Ananda Kannan / ; Steven Kymes / ; G V S Murthy / ; Ivan Schwab / ; Thomas M Lietman / ; Nisha R Acharya / ; David V Glidden / ; Stephen D McLeod / ; John P Whitcher / ; Salena M Lee / ; Kathryn J Ray / ; Vicky Cevallos / ; Catherine E Oldenburg / ; Kevin C Hong / ; Stephanie Costanza / ; Donald F Everett / ; Michael E Zegans / ; Christine M Kidd /
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  The steroids for corneal ulcers trial: study design and baseline characteristics.
Next Document:  Automatic extraction of microorganisms and their habitats from free text using text mining workflows...