Steroids and Cross-Linking for Ulcer Treatment: The SCUT II Randomized Clinical Trial
Abstract
Importance
Adjunctive topical corticosteroids and/or corneal cross-linking (CXL) have the potential to improve outcomes in bacterial keratitis.
Objective
To determine the benefit of adjunctive topical difluprednate and CXL with riboflavin in addition to topical antibiotics.
Design, Setting, and Participants
This was a National Institutes of Health (NIH)-funded, sham, placebo-controlled trial randomizing participants to topical moxifloxacin, 0.5%, plus topical placebo plus sham CXL, vs topical moxifloxacin, 0.5%, plus difluprednate, 0.05%, plus sham CXL, vs topical moxifloxacin, 0.5%, plus difluprednate, 0.05%, plus CXL. Between September 2020 and October 2023, participants in clinics at the Aravind Eye Hospitals in India and Bascom Palmer Eye Institute, University of Miami, in Miami, Florida, were screened for inclusion. Included participants had smear- and/or culture-positive bacterial corneal ulcers with Snellen visual acuity of 20/40 or worse.
Main Outcomes and Measures
The primary outcome was logMAR best spectacle-corrected visual acuity (BSCVA) at 6 months.
Results
Of the 1992 participants with smear-positive bacterial corneal ulcers screened, 280 participants (14%; mean [SD] age, 51 [16] years; 182 male [65%]) were enrolled. After controlling for baseline, there was no difference in 6-month VA with adjunctive topical steroids vs placebo (-0.04; 95% CI, -0.18 to 0.09; P = .58) or with adjunctive CXL and topical steroids vs topical steroids alone (0.04; 95% CI, -0.09 to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 280 participants or records.
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