Evidence map›Paper›PMID 18829631›Full record

Trial reportThe British journal of ophthalmology2009

Corticosteroids for bacterial corneal ulcers.

M Srinivasan, P Lalitha, R Mahalakshmi, N V Prajna, J Mascarenhas, J D Chidambaram, S Lee, K C Hong, M Zegans, D V Glidden and 4 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The British journal of ophthalmology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.

  1. Topical corticosteroids as adjunctive therapy for bacterial keratitis.The Cochrane database of systematic reviews · 2014
    Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. The steroids for corneal ulcers trial: study design and baseline characteristics.Archives of ophthalmology (Chicago, Ill. : 1960) · 2012
    Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Genipin Delays Corneal Stromal Enzymatic Digestion.Translational vision science & technology · 2021
    Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Role of steroids in the treatment of bacterial keratitis.Clinical ophthalmology (Auckland, N.Z.) · 2016
    Review
  20. Article
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

14 authors at 4 institutions in 2 countries.

M SrinivasanAravind Eye Care System, Madurai, India.
P Lalitha
R Mahalakshmi
N V Prajna
J Mascarenhas
J D Chidambaram
S Lee
K C Hong
M Zegans
D V Glidden
S McLeod
J P Whitcher
T M Lietman
N R Acharya
Aravind Eye Hospital · INUniversity of California, San Francisco · USSan Francisco Foundation · USDartmouth College · US

Funding

Rapid-Prototyping and Design CoreP30EY002162 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI LAMBA, DEEPAK ASHOK · 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
Biofilm Formation And P. aeruginosa infection of the eyeK08EY013977 · NEI · DARTMOUTH COLLEGE · PI ZEGANS, MICHAEL ERIC · 2002 to 2006
$969k
NEI NIH HHS EY 02162NEI NIH HHS K08 EY013977NEI NIH HHS K08 EY 13977-01NEI NIH HHS K23 EY 017897NEI NIH HHS K23 EY017897NEI NIH HHS P30 EY002162NEI NIH HHS U10 EY 015114NEI NIH HHS U10 EY015114
6 · The paper itself

Abstract

aimsThe aim of the study was to conduct a preliminary clinical trial to assess whether adjunctive topical corticosteroids improve outcomes in bacterial keratitis and, if no difference was found, to determine the feasibility and sample size necessary for conducting a larger trial to answer this question.

methodsIn this single centre, double-masked clinical trial, 42 patients with culture-confirmed bacterial keratitis at Aravind Eye Hospital in India were randomised to receive either topical prednisolone phosphate or placebo. All patients received topical moxifloxacin. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 3 months, adjusting for enrolment BSCVA and arm. Other pre-specified outcomes included re-epithelialisation time, infiltrate/scar size and adverse events.

resultsCompared with placebo, patients in the steroid group re-epithelialised more slowly (hazard ratio 0.47, 95% CI 0.23 to 0.94). There was no significant difference in BSCVA or infiltrate/scar size at 3 weeks or 3 months. To have 80% power to detect a two-line difference in acuity, 360 cases would be required.

conclusionsAlthough corticosteroid treatment resulted in a statistically significant delay in re-epithelialisation, this did not translate to a significant difference in visual acuity, infiltrate/scar size or adverse events. To assess the effect of steroids on acuity, a larger trial is warranted and feasible.

Indexed as

AdultAgedCorneal UlcerDouble-Blind MethodEpithelium, CornealEye Infections, BacterialFeasibility StudiesFemaleGlucocorticoidsHumansMaleMiddle AgedOphthalmic SolutionsPrednisoloneTreatment OutcomeVisual AcuityGlucocorticoidsOphthalmic SolutionsPrednisoloneprednisolone phosphate

Identifiers

PMID18829631
PMCPMC2632719
OpenAlexW1994062792

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.