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临床试验/NCT05175729
NCT05175729已完成不适用

Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy

Akdeniz University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月1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
100
试验地点
1
主要终点
Corneal thickness

研究概览

简要总结

The aim of this study is to evaluate anterior segment changes during and after pregnancy, and compare them with non pregnant healty women

详细描述

Pregnancy is a physiological process in which many systems such as cardiovascular, pulmonary, renal, hematological and visual systems are affected, especially the endocrine system. Many organs, including the eye and orbit, are affected by the physiological interaction between the fetus and the mother. In most pregnant women, these effects are at the physiological level and are temporary; Sometimes it can be pathological and permanent. Hormonal, coagulative and hemodynamic changes are responsible for most of the ocular adaptations. Changes in corneal curvature, sensitivity and thickness are observed during pregnancy. It has been reported that corneal curvature increases with pregnancy, this increase occurs in the last trimester and returns to first trimester values at the end of the breastfeeding period. Although the etiology of this steepening of the cornea has not been clearly clarified, it is thought that it may be due to corneal edema caused by hormonal changes. However, it's not recommended for pregnant women to prescribe contact lenses because their variable keratometric values. A decrease in corneal sensitivity during pregnancy has been detected by esthesiometry in many studies. It decreases especially in the third trimester and returns to normal around the 2nd month after delivery. The corneal thickness measured by pachymeter may increase in pregnant women. some of them had myopic shift. In a study, 83 pregnant women were examined to determine the causes of visual disturbances during pregnancy and postpartum period. Previous studies reported that there was a change in favor of myopia (-0.9±0.3D) during pregnancy and it returned to pre-pregnancy levels in the postpartum period. Unstable refractions were thought to be due to changes in corneal thickness and curvature.

As a result, it was stated that the refractive change was temporary and in favor of myopia. It is recommended to wait up to several weeks postpartum before prescribing new eyeglasses [8].

There are various reports about IOP in normal pregnant women. In most of these studies, a decrease was found in IOP during pregnancy. In a prospective study, a decrease in IOP was found in the second and third trimesters of pregnancy, and it was shown that this change returned in the first month postpartum.

Before planning an anterior segment surgeries such as cataract and refractive surgery, changes in pregnancy should be taken into account and attention should be paid to surgical timing. The aim of this study is to reveal whether there is a change in anterior segment parameters in pregnancy period

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
19 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Ages between 20-40 years
  • Pregnant women with a gestational age less than 14 weeks in the first examination
  • Having no systemic disease before and during pregnancy
  • Having a spherical refractive error of less than 4 diopters, and/or had a cylindrical refractive error of less than 2 diopters

排除标准

  • Having systemic disease, having ocular pathology that may decrease visual acuity
  • Usage of systemic drugs or topical ocular drops
  • Usage of exogenous hormones and entered menopause

结局指标

主要结局

Corneal thickness

时间窗: 40 weeks

Corneal thickness in mikrometer value

Anterior chamber volume

时间窗: 40 weeks

Anterior chamber volume in mm3

Auto refractometer

时间窗: 40 weeks

Refractive error measurement in diopter

Axial length

时间窗: 40 weeks

Axial length in mm

Anterior chamber depth

时间窗: 40 weeks

Anterior chamber depth in mm

Anterior chamber angle

时间窗: 40 weeks

Anterior chamber angle in degree

Mean keratometry

时间窗: 40 weeks

in Diopters

Anterior flat keratometry

时间窗: 40 weeks

in Diopters

Steep keratometry

时间窗: 40 weeks

in Diopters

Tonometry

时间窗: 40 weeks

İntraocular pressure measurement in mmHg

Best corrected visual acuity assessment

时间窗: 40 weeks

Snellen and logMAR chart

Blood pressure measurement

时间窗: 40 weeks

Systemic blood pressure

Lens power

时间窗: 40 weeks

in diopters

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

Çisil Erkan Pota

Medical Doctor

Akdeniz University

研究点 (1)

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