Evidence map›Paper›PMID 21987582›Full record

Trial reportArchives of ophthalmology (Chicago, Ill. : 1960)2012

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

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 and 5 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Archives of ophthalmology (Chicago, Ill. : 1960), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00324168 (Steroids for Corneal Ulcers Trial), which is not on this map. Cited by 99 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
99citing papers in PubMed, 2 pooled it
11.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00324168 phase4completednot on this map

Steroids for Corneal Ulcers Trial

TypeinterventionalSponsorThomas M. LietmanRan2006 to 2012Enrolled500ConditionsCorneal Ulcer, Eye Infections, BacterialArmsAntibiotics, Topical corticosteroid, Placebo
3 · Its place in the literature

Who cites it

99 citing papers in PubMed, 2 syntheses or guidelines pooled it, 212 citations in OpenAlex.

  1. Pooled it
  2. Topical corticosteroids as adjunctive therapy for bacterial keratitis.The Cochrane database of systematic reviews · 2014
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39 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

Muthiah SrinivasanDepartments of Cornea and External Diseases, Aravind Eye Care System, Madurai, India.
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
Aravind Eye Hospital · IN

Funding

Rapid-Prototyping and Design CoreP30EY002162 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ULLIAN, ERIK M · 1985 to 2024
$16.8M
The Steroids for Cornea Ulcers TrialU10EY015114 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI LIETMAN, THOMAS M · 2005 to 2009
$2.4M
Predicting and Improving Clinical Outcomes for Bacterial KeratitisK23EY017897 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ACHARYA, NISHA · 2007 to 2011
$1.1M
NEI NIH HHS EY02162NEI NIH HHS K23 EY017897NEI NIH HHS P30 EY002162NEI NIH HHS U10 EY015114
6 · The paper itself

Abstract

objectiveTo 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.

methodsRandomized, 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 measuresThe primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months from enrollment. Secondary outcomes included infiltrate/scar size, reepithelialization, and corneal perforation.

resultsBetween 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).

conclusionsWe 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 registrationclinicaltrials.gov Identifier: NCT00324168.

Indexed as

Administration, TopicalAdultAnti-Infective AgentsAza CompoundsBacteriaCorneaCorneal UlcerDouble-Blind MethodDrug Therapy, CombinationEye Infections, BacterialFemaleFluoroquinolonesGlucocorticoidsHumansMaleMiddle AgedAnti-Infective AgentsAza CompoundsFluoroquinolonesGlucocorticoidsMoxifloxacinPrednisoloneprednisolone phosphateQuinolines

Identifiers

PMID21987582
PMCPMC3830549
OpenAlexW2114624496

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.