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临床试验/NCT01695655
NCT01695655已完成不适用

Neovascularization Patterns in Corneal Graft Rejection

University of Michigan1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Corneal graft rejection

研究概览

简要总结

Corneal transplantation is the most commonly performed human tissue transplant worldwide. Over 40,000 corneal transplants occur in the US each year. .

This study will determine specific corneal neovascularization (CN) patterns in human corneal allograft recipients to determine the characteristics that worsen the prognosis for graft survival. We will test the hypothesis that specific characteristics of CN are prognostic for corneal allograft rejection.

详细描述

The investigators hope to enroll 240 subjects into the study. These patients will be enrolled prior to penetrating keratoplasty. They will be examined by the full protocol preoperatively, and postoperatively at 1 week, 1, 3, 6, 12, 18, and 24 months. During these visits slit lamp biomicroscopy will be used to study CN patterns, and take slit lamp photographs if there is any neovascularization detected, permitting us to develop algorithms of CN characteristics that are predictive for corneal allograft rejection and failure. The corneal tissue removed during these patients' surgeries will be evaluated histopathologically to identify inflammation and neovascularization to confirm and compare to what is seen clinically. There will be two short questionnaires conducted at each visit to assess stress levels.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • scheduled for corneal transplant

排除标准

  • previous corneal transplant

结局指标

主要结局

Corneal graft rejection

时间窗: 0 to 2 years after transplant

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

Roni Shtein

Assistant Professor

University of Michigan

研究点 (1)

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