Clinical trial NCT05175729: Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy
Official title: Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Keywords: Pregnancy
Anterior segment
Corneal Topography
Biometry
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnan women in their first pregnancy will be followed-up during pregnancy period (first, second, third trimesters) and post partum period.

Healthy age-, sex- matched control group will be used to compare

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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Corneal thickness
timeFrame: 40 weeks
measure: Anterior chamber volume
timeFrame: 40 weeks
measure: Anterior chamber depth
timeFrame: 40 weeks
measure: Anterior chamber angle
timeFrame: 40 weeks
measure: Lens power
timeFrame: 40 weeks
measure: Anterior flat keratometry
timeFrame: 40 weeks
measure: Steep keratometry
timeFrame: 40 weeks
measure: Mean keratometry
timeFrame: 40 weeks
measure: Tonometry
timeFrame: 40 weeks
measure: Best corrected visual acuity assessment
timeFrame: 40 weeks
measure: Blood pressure measurement
timeFrame: 40 weeks
measure: Auto refractometer
timeFrame: 40 weeks
measure: Axial length
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Hospital
state: Konyaaltı
Study officials:
affiliation: Akdeniz University Hospital
name: Çisil Erkan Pota, MD
role: PRINCIPAL_INVESTIGATOR
References: