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临床试验/NCT04433689
NCT04433689Unknown不适用

Change in Corneal Biomechanics During Pregnancy

University of Zurich1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Change in corneal thickness

研究概览

简要总结

It is known that intraocular pressure changes during pregnancy. Collagen structure changes during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and, thus, ultimately to enable delivery of a child. The cornea consists of highly structured collagen fibers. Hence, it seams logically that corneal biomechanics also change during pregnancy.

详细描述

It is known that intraocular pressure changes during pregnancy. Collagen structure changes during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and, thus, ultimately to enable delivery of a child. The cornea consists of highly structured collagen fibers. Hence, it seams logically that corneal biomechanics also change during pregnancy.

Measurement of intraocular pressure is highly dependant on corneal properties. With the Corvis ST device by Ocular Inc. it is possible to measure intraocular pressure and investigated corneal biomechanics. The aim of this study is therefore to compare corneal biomechanical properties during the third trimester with corneal biomechanical properties at 3 months after delivery.

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 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • age 18 to 38 yo
  • uncomplicated singleton pregnancy

排除标准

  • any history of ocular disease or surgery other than conjunctivitis, especially no history of glaucoma or corneal disease
  • systemic diseases, i.e. diabetes, hypertension, collagenase
  • current contact lens wear
  • before pregnancy taking any systemic or ocular medications

结局指标

主要结局

Change in corneal thickness

时间窗: at 3 month post delivery compared to during third trimester of the pregnancy

Change in corneal thickness (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.

Change in Intraocular pressure

时间窗: at 3 month post delivery compared to during third trimester of the pregnancy

Change in intraocular pressure (in millimeters of mercury, mmHg) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.

Change in Deformation Amplitude

时间窗: at 3 month post delivery compared to during third trimester

Change in Deformation Amplitude (in millimeters) at 3 month post delivery compared to during third trimester will be assessed.

Change in Corneal Velocity

时间窗: at 3 month post delivery compared to during third trimester of the pregnancy

Change in Corneal Velocity (in meters/second) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.

Change in Applanation Length

时间窗: at 3 month post delivery compared to during third trimester of the pregnancy

Change in Applanation Length (in millimeters) at 3 month post delivery compared to during third trimester of the pregnancy will be assessed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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