Oct. 10, 2011 Topical corticosteroids do not appear to be effective for improving visual acuity (sharpness of vision) in patients with bacterial corneal ulcers, according to two reports published Online First by Archives of Ophthalmology, one of the JAMA/Archives journals.
"The use of topical corticosteroids as adjunctive therapy in the treatment of bacterial corneal ulcers has been debated extensively during the past few decades," the authors write as background information in one of the articles. "The American Academy of Ophthalmology suggests that although there may be a role for corticosteroids in the treatment of bacterial corneal ulcers, there is insufficient evidence to make an official recommendation."
Muthiah Srinivasan, M.D., of Aravind Eye Care System, Madurai, India, and colleagues designed a randomized controlled trial, The Steroids for Corneal Ulcers Trial (SCUT), to examine the effectiveness of corticosteroid therapy for treatment of bacterial corneal ulcers. Between September 2006 and February 2010, 500 participants recruited in India and the United States were enrolled; 50 percent of whom (250 patients) were randomized to receive corticosteroid treatment and 50 percent were randomized to the placebo group. Of the 500 patients enrolled, 442 (88.4 percent) completed their three-month visit within the study window and were included in the analysis.
The first report outlined the SCUT study design and characteristics, and examined differences in study participants from the United States and those from India. Of the 500 participants, 485 (97 percent) were from India, and 220 patients (44 percent) were manual agricultural workers. Visual acuity at study enrollment was not significantly different between patients in India and those in the U.S. The authors also found that ulcers in patients from India had larger scar sizes, were graded as significantly deeper and were more likely to be centrally located within the eye than ulcers in patients from the U.S.
In a second article, the same authors reported results of the Steroids for Corneal Ulcers Trial. At the three-month follow-up, the authors tested participants' best-corrected (with glasses) visual acuity. After controlling for visual acuity level at enrollment, analysis showed no significant improvement in best-corrected visual acuity for participants in the corticosteroid treatment group versus participants receiving placebo.
The authors also compared adverse events in each treatment group and found no significant difference in the number of corneal perforations between treatment groups. More patients receiving placebo developed intraocular pressure greater than 25 mm Hg (millimeters of mercury) but no intraocular pressure of greater than 35 mm Hg was observed in either group.
"In conclusion, the SCUT found no overall difference in three-month visual acuity with the use of topical corticosteroids as adjunctive therapy for bacterial keratitis compared with placebo," the authors write. "Pre-specified subgroup analyses suggest that there may be a role for topical corticosteroids in ulcers that are more severe at baseline. However, a larger study examining only severe corneal ulcers is needed to confirm this supposition."
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- 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; for the Steroids for Corneal Ulcers Trial Group. The Steroids for Corneal Ulcers Trial: Study Design and Baseline Characteristics. Archives of Ophthalmology, 2011; DOI: 10.1001/archophthalmol.2011.303
- 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; for the Steroids for Corneal Ulcers Trial Group. Corticosteroids for Bacterial Keratitis: The Steroids for Corneal Ulcers Trial (SCUT). Archives of Ophthalmology, 2011; DOI: 10.1001/archophthalmol.2011.315
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