Corticosteroids for Bacterial Corneal Ulcers
- Muthiah Srinivasan (m.srinivasan{at}aravind.org),
- Prajna Lalitha (lalitha{at}aravind.org),
- Rajendran Mahalakshmi (mahalakshmirajendran{at}gmail.com),
- Namperumalsamy V. Prajna (prajna{at}aravind.org),
- Jeena Mascarenhas (jeena{at}aravind.org),
- Jaya D. Chidambaram (jaya{at}doctors.org.uk),
- Salena Lee (salena.lee{at}ucsf.edu),
- Kevin C. Hong (kevin.hong{at}ucsf.edu),
- Michael E. Zegans (michael.e.zegans{at}dartmouth.edu),
- David V. Glidden (dave{at}biostat.ucsf.edu),
- Stephen McLeod (mcleods{at}vision.ucsf.edu),
- John P. Whitcher (jack.whitcher{at}ucsf.edu),
- Thomas M. Lietman (tom.lietman{at}ucsf.edu),
- Nisha R. Acharya (nisha.acharya{at}ucsf.edu)
- Aravind Eye Hospital, India
- Aravind Eye Hospital, India
- Aravind Eye Hospital, India
- Aravind Eye Hospital, India
- Aravind Eye Hospital, India
- F. I. Proctor Foundation, United States
- F. I. Proctor Foundation, United States
- F. I. Proctor Foundation, United States
- Dartmouth Medical School, United States
- University of California, San Francisco, United States
- University of California, San Francisco, United States
- F. I. Proctor Foundation, United States
- F. I. Proctor Foundation, United States
- F. I. Proctor Foundation, United States
- Published Online First 1 October 2008
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
