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Corticosteroids for Bacterial Corneal Ulcers
  1. Muthiah Srinivasan (m.srinivasan{at}aravind.org),
  2. Prajna Lalitha (lalitha{at}aravind.org),
  3. Rajendran Mahalakshmi (mahalakshmirajendran{at}gmail.com),
  4. Namperumalsamy V. Prajna (prajna{at}aravind.org),
  5. Jeena Mascarenhas (jeena{at}aravind.org),
  6. Jaya D. Chidambaram (jaya{at}doctors.org.uk),
  7. Salena Lee (salena.lee{at}ucsf.edu),
  8. Kevin C. Hong (kevin.hong{at}ucsf.edu),
  9. Michael E. Zegans (michael.e.zegans{at}dartmouth.edu),
  10. David V. Glidden (dave{at}biostat.ucsf.edu),
  11. Stephen McLeod (mcleods{at}vision.ucsf.edu),
  12. John P. Whitcher (jack.whitcher{at}ucsf.edu),
  13. Thomas M. Lietman (tom.lietman{at}ucsf.edu),
  14. Nisha R. Acharya (nisha.acharya{at}ucsf.edu)
  1. Aravind Eye Hospital, India
  2. Aravind Eye Hospital, India
  3. Aravind Eye Hospital, India
  4. Aravind Eye Hospital, India
  5. Aravind Eye Hospital, India
  6. F. I. Proctor Foundation, United States
  7. F. I. Proctor Foundation, United States
  8. F. I. Proctor Foundation, United States
  9. Dartmouth Medical School, United States
  10. University of California, San Francisco, United States
  11. University of California, San Francisco, United States
  12. F. I. Proctor Foundation, United States
  13. F. I. Proctor Foundation, United States
  14. F. I. Proctor Foundation, United States

    Abstract

    Aims: To conduct a preliminary clinical trial assessing whether adjunctive topical corticosteroids improve outcomes in bacterial keratitis and, if no difference is found, to determine the feasibility and sample size necessary for conducting a larger trial to answer this question.

    Methods: In this single center, double-masked clinical trial, 42 patients with culture-confirmed bacterial keratitis at Aravind Eye Hospital in India were randomized 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 enrollment BSCVA and arm. Other pre-specified outcomes included re-epithelialisation time, infiltrate/scar size, and adverse events.

    Results: Compared to placebo, 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 2-line difference in acuity, 360 cases would be required.

    Conclusions: Although 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.

    Registered at http://clinicaltrials.gov, Steroids for Corneal Ulcers Trial, NCT: NCT00324168

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