AIMS: The 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. METHODS: In 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. RESULTS: Compared 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. 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.
RCT Entities:
AIMS: The 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. METHODS: In 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. RESULTS: Compared 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. 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.
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 Journal: Arch Ophthalmol Date: 2011-10-10
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 Journal: Arch Ophthalmol Date: 2011-10-10
Authors: Aileen Sy; Muthiah Srinivasan; Jeena Mascarenhas; Prajna Lalitha; Revathi Rajaraman; Meenakshi Ravindran; Catherine E Oldenburg; Kathryn J Ray; David Glidden; Michael E Zegans; Stephen D McLeod; Thomas M Lietman; Nisha R Acharya Journal: Invest Ophthalmol Vis Sci Date: 2012-01-25 Impact factor: 4.799
Authors: Muthiah Srinivasan; Jeena Mascarenhas; Revathi Rajaraman; Meenakshi Ravindran; Prajna Lalitha; Kieran S O'Brien; David V Glidden; Kathryn J Ray; Catherine E Oldenburg; Michael E Zegans; John P Whitcher; Stephen D McLeod; Travis C Porco; Thomas M Lietman; Nisha R Acharya Journal: Am J Ophthalmol Date: 2013-10-01 Impact factor: 5.258
Authors: Christine M Toutain-Kidd; Travis C Porco; Eric M Kidd; M Srinivasan; Namperumalsamy V Prajna; Nisha Acharya; Thomas Lietman; Michael E Zegans Journal: Ophthalmic Epidemiol Date: 2014-02 Impact factor: 1.648
Authors: Nina Ni; Muthiah Srinivasan; Stephen D McLeod; Nisha R Acharya; Thomas M Lietman; Jennifer Rose-Nussbaumer Journal: Curr Opin Ophthalmol Date: 2016-07 Impact factor: 3.761
Authors: Nisha R Acharya; Muthiah Srinivasan; Jeena Mascarenhas; Meenakshi Ravindran; Revathi Rajaraman; Michael Zegans; Stephen McLeod; Thomas M Lietman Journal: Arch Ophthalmol Date: 2009-09