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临床试验/NCT04420962
NCT04420962已完成不适用

Quantifying Microbial Keratitis to Predict Outcomes

University of Michigan2 个研究点 分布在 2 个国家目标入组 124 人开始时间: 2020年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
2
主要终点
Visual Acuity

研究概览

简要总结

This is a multiple site observational study that will review patient features (clinical and morphologic) over a 90 day period during care of participants with microbial keratitis with presence of clinically significant ≥2mm stromal infiltrate compared with participants with other forms of keratitis.

详细描述

The primary objective of this study is to determine associations between participant features (clinical and morphologic) and best corrected visual acuity at Day 90. Imaging, focused on slit lamp photography and supplemented by other imaging markers will be collected for review. A medical record review at one year following participants initial visit will record any corneal procedure and visual acuity testing that occurred during this window. Participants will complete demographic, clinical, and standardized health surveys.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
15 Years 至 99 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cases- microbial keratitis (bacterial or fungal) with presence of clinically significant ≥2mm stromal infiltrate
  • Controls- Inflammatory, viral, Acanthamoeba, or other keratitis

排除标准

  • Pregnancy
  • Prior incisional corneal surgery
  • No light perception vision
  • Corneal perforation or impending perforation
  • Inpatient status
  • Institutional status
  • Cognitively impaired

结局指标

主要结局

Visual Acuity

时间窗: 90 day follow up

Visual Acuity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Woodward

Assistant Professor

University of Michigan

研究点 (2)

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