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临床试验/NCT01629264
NCT01629264已完成不适用

Influence of Pregnancy-related Hormonal Fluctuations on Corneal Biomechanics in Humans

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年6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
50
试验地点
1
主要终点
Correlate oestradiol and TSH plasma changes with changes in corneal CRF and CH and topographical changes

研究概览

简要总结

The intraocular pressure in the human bulbus requires that the "wall" of the eye shows a certain (bio)mechanical strength. The human cornea represents the anterior portion of this wall. Since several years, there is a growing interest in the ophthalmological community for identifying factors modulating the biomechanical stability of the human cornea. Reasons are twofold: advances in keratoconus research and the increasing numbers of refractive laser surgery procedures with (correspondingly) increasing numbers of complications due to non-respecting the limits of corneal biomechanics.

There is evidence that oestrogen, but also thyroïd hormone changes have a major impact on corneal biomechanics. A number of recent observational studies have reported on keratoconus and refractive laser surgery patients with decompensating biomechanics during pregnancy.

Both hormones also show physiological changes during pregnancy and little is known about the impact of these physiological changes on the human cornea.

The aim of this study is to establish baseline values for physiological changes in the human cornea during pregnancy.

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
Female
接受健康志愿者

入选标准

  • Older than 18 years
  • Pregnancy confirmed by echography
  • Before gestation week 14

排除标准

  • Pre-existing corneal disease
  • Previous eye surgery
  • Inability to understand the nature of the study
  • Patient with legal guardian

结局指标

主要结局

Correlate oestradiol and TSH plasma changes with changes in corneal CRF and CH and topographical changes

时间窗: 15 months

3 examinations during pregnancy (gestation week 10-14, 20-26, and 36-40) and one visit at 6 months after pregnancy

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

Farhad Hafezi

Professor and Chairman of Ophthalmology

University Hospital, Geneva

研究点 (1)

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