Kowalska Malwina E, Hafezi Farhad, Pot Simon A, Hartnack Sonja
Ophthalmology Section, Equine Department, Vetsuisse Faculty, University of Zurich, CH-8057 Zurich, Switzerland.
Section of Epidemiology, Vetsuisse Faculty, University of Zurich, CH-8057 Zurich, Switzerland.
Animals (Basel). 2022 Oct 20;12(20):2862. doi: 10.3390/ani12202862.
Infectious keratitis is a common and painful disease, usually caused by bacteria in dogs. Brachycephalic breeds are at increased risk. Despite medical therapy, enzymatic corneal melting can lead to ulcer perforation and globe loss. Treatment alternatives are needed due to an increase in antibiotic resistance and growing popularity of brachycephalic dogs. Photoactivated Chromophore for Keratitis-Corneal Cross-linking (PACK-CXL) reduces enzymatic collagenolysis and damages multiple targets within microorganisms, resulting in corneal tissue stabilization and elimination of bacteria, irrespective of their antibiotic resistance status. A randomized controlled trial providing evidence of PACK-CXL effectiveness in dogs is lacking. We aim to determine whether PACK-CXL is a viable alternative to conventional medical therapy for canine infectious keratitis. Two hundred-and-seventy client-owned dogs with presumed infectious keratitis will be allocated to two equally sized treatment groups (PACK-CXL or medical therapy) in a masked, randomized, controlled, multicenter trial in eleven clinics. The primary outcome measure is treatment success defined as complete epithelial closure within 28 days. The sample size is based on a group sequential design with two interim analyses, which will be overseen by a Data Safety and Monitoring Board. Ethical approvals have been obtained. The study protocol is preregistered at preclinicaltrials.eu. Publishing trial protocols improves study reproducibility and reduces publication bias.
感染性角膜炎是一种常见且痛苦的疾病，通常由犬类细菌引起。短头品种犬患病风险更高。尽管进行了药物治疗，但酶性角膜溶解仍可导致溃疡穿孔和眼球丧失。由于抗生素耐药性增加以及短头犬越来越受欢迎，需要其他治疗方法。用于角膜炎的光活化发色团角膜交联术（PACK-CXL）可减少酶性胶原溶解，并破坏微生物内的多个靶点，从而实现角膜组织稳定并消除细菌，无论其抗生素耐药状态如何。目前缺乏一项能证明PACK-CXL对犬有效力的随机对照试验。我们旨在确定PACK-CXL是否是犬感染性角膜炎传统药物治疗的可行替代方案。在一项由11家诊所参与的、采用盲法、随机、对照、多中心试验中，270只疑似感染性角膜炎的客户拥有的犬将被分配到两个规模相等的治疗组（PACK-CXL组或药物治疗组）。主要结局指标是治疗成功，定义为在28天内完全上皮闭合。样本量基于具有两次中期分析的成组序贯设计，这将由数据安全与监测委员会监督。现已获得伦理批准。该研究方案已在preclinicaltrials.eu上预先注册。公布试验方案可提高研究的可重复性并减少发表偏倚。
