权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

Steroids and Cross-linking for Ulcer Treatment (SCUT II)

类固醇和交联治疗溃疡 (SCUT II)

基本信息

批准号：
10666415
负责人：
THOMAS M LIETMAN
金额：
$ 74.59万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10666415
关键词：
Address Adjuvant Adjuvant Therapy Affect Age Agreement Anterior Anti-Inflammatory Agents Antibiotic Therapy Antibiotic susceptibility Antibiotics Asia Astigmatism Bacterial Infections Biological Blindness Case Series Case Study Cataract Cell secretion Cells Characteristics Cicatrix Clinical Clinical Trials Design Collaborations Collagen Confocal Microscopy Cornea Corneal Opacity Corneal Ulcer Country Developing Countries Drug resistance Eligibility Determination Enzymes Eye Eyeglasses Funding Future Genus Mycobacterium Hospitals Image Imaging Techniques Immune In Vitro India Infection Infectious Agent Inflammation Inflammatory Inflammatory Response International Investigation Keratitis Masks Measures Monocular Vision Morbidity - disease rate Moxifloxacin Operative Surgical Procedures Optics Organism Outcome Patients Penetrating Keratoplasty Perforation Persons Placebos Process Prognosis Pseudomonas aeruginosa Quality of life Randomized Randomized Controlled Clinical Trials Randomized, Controlled Trials Rehabilitation therapy Research Resistance Resolution Riboflavin Role Specific qualifier value Steroids Streptococcus pneumoniae Subgroup Technology Testing Therapeutic Tissues Topical Antibiotic Topical Corticosteroids Ulcer Visual Visual Acuity Visual impairment acute infection arm burden of illness collagenase corneal scar crosslink cytokine design disability healing high resolution imaging improved improved outcome innovation melting novel optimal treatments pathogen pathogenic bacteria prospective protein degradation randomized controlled design randomized trial randomized, clinical trials success symptomatic improvement treatment group trial comparing

项目摘要

PROJECT SUMMARY/ABSTRACT Investigating factors that mitigate the inflammatory response to infection may have the greatest impact on clinical outcomes in bacterial keratitis. Well-designed randomized controlled trials comparing different topical antibiotics have been unable to identify any significant difference of treatment success. Activated immune cells secret cytokines and collagenases which lead to destruction of corneal tissue. Simultaneous treatment of inflammation may reduce corneal astigmatism and opacity, thus improving visual acuity outcomes. The Steroids for Corneal Ulcer Trial (SCUT) was unable to identify a benefit or harm to the use of adjuvant steroids in the treatment of bacterial ulcers overall, however, hypothesis-generating subgroup analysis consistently suggested a benefit in severe, non-Nocardia ulcers treated with early steroids. Here, we propose the Steroids and Cross-linking for Ulcer Treatment II (SCUT II), an international, randomized, double-masked, clinical trial designed to evaluate the benefit of adjuvant corneal cross-linking (CXL) and early steroids in the treatment of bacterial ulcers. Patients presenting to one of the Aravind Eye Hospitals in India or to UCSF with smear-positive typical (i.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of three treatment groups: Group 1: Standard Therapy Group, topical 0.5% moxifloxacin plus topical placebo plus sham CXL Group 2: Early Steroid Group, topical 0.5% moxifloxacin plus topical 0.05% difluprednate plus sham CXL Group 3: CXL Group, topical 0.5% moxifloxacin plus topical 0.05% difluprednate plus CXL This approach is innovative for a number of reasons including its testing of novel treatments such as topical difluprednate 0.05% and corneal cross-linking. It is also aligned with the priorities of the NEI including the study of infectious processes, as well as studying new high-resolution imaging techniques such as confocal microscopy, anterior-segment optical coherence and Pentacam Scheimflug imaging to guide treatment of corneal ulceration and as potential surrogate trial endpoints in future trials. Proctor has a proven track record of studying the optimal treatment of corneal ulceration with large NEI-funded trials. Corneal opacity remains one of the leading causing of blindness worldwide and we anticipate that this research will guide clinicians on the best management of cornea infection to reduce the morbidity associated with this condition.

项目总结/文摘