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Clinical trial evaluates efficacy of steroid use for corneal ulcers
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A multicenter study aims to solve a decades-long debate on treatment choices for corneal ulcers.
The Steroids for Corneal Ulcers Trial (SCUT), which was scheduled to be completed in June, was designed to determine whether the addition of a topical steroid to antibiotic therapy improves the outcome of bacterial corneal ulcers.
According to the U.S. National Institutes of Health at ClinicalTrials.gov, some clinicians advocate the use of steroids in addition to antibiotics to reduce immune-mediated tissue damage and scarring that can result from corneal ulcers. Others feel steroid use will prolong or exacerbate the infection.
Study director Thomas M. Lietman, MD, told Primary Care Optometry News that an earlier, smaller trial showed that steroid-treated cases had one line better acuity at 3 months, “although the results were not significant,” he said. “Steroid-treated cases did take slightly longer to re-epithelialize.”
Dr. Lietman, who is also professor in residence at the University of California, San Francisco, said the SCUT study results were expected to be released some time this fall.
In this randomized, double-masked, placebo-controlled trial, best corrected logMAR visual acuity 3 months after enrollment, using best spectacle-corrected enrollment visual acuity as a co-variate, is the primary outcome measure, according to the ClinicalTrials.gov website.
Secondary outcome measures include the infiltrate or scar size, best gas-permeable lens-corrected visual acuity, time to resolution of epithelial defect, ocular perforations and the correlation between the best-corrected visual acuity and minimum inhibitory concentration to moxifloxacin. The causative organism, visual acuity group, duration of symptoms prior to enrollment and depth of the ulcer are also being taken into account.
Five hundred bacterial corneal ulcers were tested in the trial. Patients at the Aravind Eye Hospitals in India; the University of California, San Francisco (UCSF) Proctor Foundation; and the Dartmouth-Hitchcock Medical Center were randomized into two arms (250 in each), one treated with antibiotics and steroids, the other with antibiotics and placebo. Post-administration, patients were followed closely until re-epithelialization. Follow-up visits were at 3 weeks, 3 months and 12 months post enrollment.
All patients were administered moxifloxacin 0.5% every hour for 48 hours while awake, then every 2 hours until re-epithelialization. Those in the steroid arm also received prednisolone phosphate 1% with preservative four times a day for 1 week, twice daily for 1 week, then daily for 1 week.
“The results of SCUT should inform clinicians whether it is appropriate to use steroids along with antibiotics in bacterial ulcer cases,” Dr. Lietman said. “We plan to follow up on this study with future clinical trials on subgroups of cases.”
M. Srinivasan, MS, DO, Aravind Eye Hospital; Mike Zegans, MD, Dartmouth-Hitchcock Medical Center; Nisha Acharya, MD, MS, Proctor Foundation, UCSF; Salena Lee, OD, Proctor Foundation, UCSF; and Stephen McLeod, MD, UCSF, are co-investigators. The trial is sponsored by the University of California, San Francisco. – by Daniel Morgan
- Thomas M. Lietman, MD, can be reached at (415) 476-1442; tom.lietman@ucsf.edu.
- To access information on the trial, go to www.clinicaltrials.gov/ct2/show/NCT00324168.