The Steroids for Corneal Ulcers Trial (SCUT): Secondary 12-Month Clinical Outcomes of a Randomized Controlled Trial

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 pre-specified regression models (BSCVA: −0.04 logMAR, 95%CI, −0.12 to 0.05, P=0.39; scar size: 0.03mm, 95% CI, −0.12 to 0.18, P=0.69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean one-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (−0.10 logMAR, 95%CI, −0.19 to −0.02, P=0.02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, −0.04 to 0.41, P=0.16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47mm, 95% CI, 0.06 to 0.88, P=0.02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (−0.06mm, 95%CI, −0.21 to 0.10, P=0.46). Conclusions Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species.

Visual Outcomes in Treated Bacterial Keratitis: Four Years of Prospective Follow-up

“…This observation is consistent with the 12-month SCUT results, and may indicate a potential long-term benefit of corticosteroids in non-Nocardia ulcers. 11 We also observed similar rates of cataract and glaucoma in the 2 treatment groups at 4 years, suggesting that a short course of adjunctive corticosteroids for bacterial keratitis appears to have a reasonable long-term safety profile. Analyses comparing the corticosteroid and placebo groups must be interpreted with caution, since the current study population is only a small subset of the overall trial population.…”

Pattern recognition receptors in microbial keratitis

“…Those with the most significant improvement in visual outcomes were those whose baseline vision was poorest, with most of the improvement occurring within the first 3 months for all patients. 199,201,202 In the search for more specific, tailored therapies, molecular targets are being investigated as a means of reducing tissue damage and restoring sight. Various avenues are being explored according to specific pathogen characteristics and cellular pathways.…”

Levofloxacin and Tobramycin for Severe Bacterial Keratouveitis

“…The new SCUT study has recently noted that topical steroids may be associated with improved long-term clinical outcomes at 12 months in bacterial corneal ulcers not caused by Nocardia species. 48 In conclusion, bacterial corneal ulcers with severe anterior chamber inflammation need a close followup. CL wear is the most frequent risk factor and it is recommended, whenever possible, to perform a cultural exam on contact lens at the onset of keratitis.…”