跳至主要内容
临床试验/NCT01060787
NCT01060787已完成不适用

An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year

Bausch & Lomb Incorporated1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2016年2月4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
98
试验地点
1
主要终点
Corneal Endothelial Cell Density

研究概览

简要总结

Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants

详细描述

Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.

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
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Had the FA intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one(1) year
  • Able and willing to follow instructions
  • Able and willing to provide informed consent
  • Exclusion criteria:
  • Is monocular
  • Has current or relevant medical history that would interfere with their participation in this study, based on the judgment of the Investigator
  • Had bilateral FA intravitreal implants
  • Has a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study

排除标准

  • 未提供

结局指标

主要结局

Corneal Endothelial Cell Density

时间窗: 1 Visit

Bilateral specular microscopy will be performed and endothelial cell density will be recorded.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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