Introduction Although antibiotics are successful at achieving microbiological cure in infectious keratitis, outcomes are often poor due to corneal scarring. Ideal treatment of corneal ulcers would address both the infection and the inflammation. Adjunctive topical steroid treatment may improve outcomes by reducing inflammation. Corneal cross-linking (CXL) is a novel prospective therapy that may simultaneously reduce both inflammatory cells and bacterial pathogens. The purpose of this study is to determine differences in 6-month visual acuity between standard medical therapy with antibiotics versus antibiotics with adjunctive early topical steroid therapy versus antibiotic treatment plus CXL and early topical steroids. Methods and analysis This international, randomised, sham and placebo-controlled, three-arm clinical trial randomises patients with smear positive bacterial ulcers in a 1:1:1 fashion to one of three treatment arms: (1) topical 0.5% moxifloxacin plus topical placebo plus sham CXL; (2) topical 0.5% moxifloxacin plus difluprednate 0.05% plus sham CXL; or (3) the CXL group: topical 0.5% moxifloxacin plus difluprednate 0.05% plus CXL. Ethics and dissemination We anticipate that both adjunctive topical steroids and CXL will improved best spectacle corrected visual acuity and also reduce complications such as corneal perforation and the need for therapeutic penetrating keratoplasty. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. Our results will be disseminated via ClinicalTrials.gov website, meetings and journal publications. Our data will also be available on reasonable request. Trial registration number [NCT04097730][1]. Data are available upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04097730&atom=%2Fbmjophth%2F6%2F1%2Fe000811.atom

中文翻译：

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角膜交联和局部二氟泼尼酯治疗细菌性角膜炎的双盲、假手术和安慰剂对照试验：类固醇和交联溃疡治疗试验 (SCUT II) 研究方案


简介 虽然抗生素可以成功地实现感染性角膜炎的微生物治愈，但由于角膜疤痕，结果往往很差。角膜溃疡的理想治疗方法是同时解决感染和炎症。辅助局部类固醇治疗可以通过减少炎症来改善预后。角膜交联（CXL）是一种新颖的前瞻性疗法，可以同时减少炎症细胞和细菌病原体。本研究的目的是确定抗生素标准药物治疗与抗生素联合早期局部类固醇治疗与抗生素治疗加 CXL 和早期局部类固醇治疗之间 6 个月视力的差异。方法和分析 这项国际随机、假手术和安慰剂对照的三组临床试验以 1:1:1 的方式将涂片阳性细菌性溃疡患者随机分配至三个治疗组之一：(1) 局部用 0.5% 莫西沙星加局部用安慰剂加假 CXL； (2)局部0.5%莫西沙星加0.05%二氟泼尼酯加假CXL；或(3)CXL组：局部0.5%莫西沙星加0.05%二氟泼尼酯加CXL。伦理和传播 我们预计辅助局部类固醇和 CXL 都将提高最佳眼镜矫正视力，并减少角膜穿孔等并发症和治疗性穿透性角膜移植术的需要。本研究将遵守 NIH 数据共享政策和 NIH 资助的临床试验信息传播政策以及临床试验注册和结果信息提交规则。我们的结果将通过 ClinicalTrials.gov 网站、会议和期刊出版物传播。我们的数据也将根据合理要求提供。 试用注册号[NCT04097730][1]。数据可根据合理要求提供。 [1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04097730&atom=%2Fbmjophth%2F6%2F1%2Fe000811。原子