Muthiah Srinivasan1, Jeena Mascarenhas1, Revathi Rajaraman2, Meenakshi Ravindran3, Prajna Lalitha1, Kieran S O'Brien4, David V Glidden5, Kathryn J Ray4, Catherine E Oldenburg4, Michael E Zegans6, John P Whitcher4, Stephen D McLeod7, Travis C Porco8, Thomas M Lietman9, Nisha R Acharya10. 1. Aravind Eye Care System, Madurai, India. 2. Aravind Eye Care System, Coimbatore, India. 3. Aravind Eye Care System, Tirunelveli, India. 4. Francis I. Proctor Foundation, University of California, San Francisco, California. 5. Department of Epidemiology and Biostatistics, University of California, San Francisco, California. 6. Departments of Surgery (Ophthalmology) and Microbiology and Immunology, Dartmouth Medical School, Lebanon, New Hampshire. 7. Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. 8. Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, California. 9. Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Epidemiology and Biostatistics, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. 10. Francis I. Proctor Foundation, University of California, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, California. Electronic address: nisha.acharya@ucsf.edu.
Abstract
PURPOSE: To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. DESIGN: Randomized, placebo-controlled, double-masked clinical trial. METHODS: This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. RESULTS: No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). CONCLUSIONS: Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species.
RCT Entities:
PURPOSE: To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. DESIGN: Randomized, placebo-controlled, double-masked clinical trial. METHODS: This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. RESULTS: No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). CONCLUSIONS: Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species.
Authors: Prajna Lalitha; Muthiah Srinivasan; P Manikandan; M Jayahar Bharathi; Revathi Rajaraman; Meenakshi Ravindran; Vicky Cevallos; Catherine E Oldenburg; Kathryn J Ray; Christine M Toutain-Kidd; David V Glidden; Michael E Zegans; Stephen D McLeod; Nisha R Acharya; Thomas M Lietman Journal: Clin Infect Dis Date: 2012-03-23 Impact factor: 9.079
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
Authors: Gita Varaprasathan; Kevin Miller; Thomas Lietman; John P Whitcher; Vicky Cevallos; Masao Okumoto; Todd P Margolis; Miao Yinghui; Emmett T Cunningham Journal: Cornea Date: 2004-05 Impact factor: 2.651
Authors: Ivanka J van der Meulen; Jeroen van Rooij; Carla P Nieuwendaal; Hugo Van Cleijnenbreugel; Annette J Geerards; Lies Remeijer Journal: Cornea Date: 2008-06 Impact factor: 2.651
Authors: Kathryn J Ray; Muthiah Srinivasan; Jeena Mascarenhas; Revathi Rajaraman; Meenakshi Ravindran; David V Glidden; Catherine E Oldenburg; Catherine Q Sun; Michael E Zegans; Stephen D McLeod; Nisha R Acharya; Thomas M Lietman Journal: JAMA Ophthalmol Date: 2014-06 Impact factor: 7.389
Authors: Muthiah Srinivasan; Jeena Mascarenhas; Revathi Rajaraman; Meenakshi Ravindran; Prajna Lalitha; Kathryn J Ray; Michael E Zegans; Nisha R Acharya; Thomas M Lietman; Jeremy D Keenan Journal: Ophthalmology Date: 2014-03-05 Impact factor: 12.079
Authors: Scott M McClintic; Namperumalsamy V Prajna; Muthiah Srinivasan; Jeena Mascarenhas; Prajna Lalitha; Revathi Rajaraman; Catherine E Oldenburg; Kieran S O'Brien; Kathryn J Ray; Nisha R Acharya; Thomas M Lietman; Jeremy D Keenan Journal: Invest Ophthalmol Vis Sci Date: 2014-05-02 Impact factor: 4.799
Authors: Sumayya Ahmad; Michelle Lopez; Marwan Attala; Anat Galor; Natalie A Stanciu; Darlene Miller; Leejee Suh; Thomas Albini; Victor L Perez; Carol L Karp; Janet L Davis; Eduardo Alfonso; Richard K Forster; Guillermo Amescua Journal: Ocul Immunol Inflamm Date: 2017-10-17 Impact factor: 3.070
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: Yvonne T Wu; Tan N Truong; Connie Tam; Myra N Mendoza; Lucia Zhu; David J Evans; Suzanne M J Fleiszig Journal: Exp Eye Res Date: 2018-10-19 Impact factor: 3.467