Influence of Pregnancy-related Hormonal Fluctuations on Corneal Biomechanics in Humans
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
- 是
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
Farhad Hafezi
Professor and Chairman of Ophthalmology
University Hospital, Geneva
