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临床试验/NCT01210963
NCT01210963已完成不适用

Central Corneal Thickness After Overnight IOP Monitoring With SENSIMED Triggerfish

Sensimed AG1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Pachymetry (central corneal thickness)

研究概览

简要总结

Investigation of the occurrence of possible corneal swelling after continuous Intraocular pressure (IOP) monitoring with a contact lens-based Sensor during the sleeping period.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • glaucoma and ocular hypertension scheduled for overnight hospitalisation
  • stable IOP-lowering treatment since at least 4 weeks before study
  • at least 18 years
  • having provided informed consent

排除标准

  • contact lens wear within the last 2 years
  • contraindication for silicone lean wear
  • corneal abnormality in either eye
  • ocular infection or inflammation
  • history of ocular surgery within the last 3 months
  • full-frame metal glasses during IOP monitoring with SENSIMED Triggerfish
  • pregnancy and lactation
  • patients not able to understand the nature of the research
  • patients under tutelage
  • patients committed to an institution by virtue of an order issued either by the courts or by an authority
  • simultaneous participation in other clinical research

结局指标

主要结局

Pachymetry (central corneal thickness)

时间窗: after 8 hours nocturnal continuous IOP monitoring

次要结局

未报告次要终点

研究者

发起方
Sensimed AG
申办方类型
Industry

研究点 (1)

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