Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy

Pregnancy Related Clinical Trial

Official title:

Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05175729
• Other study ID #: Study 2
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: August 2022
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Diagnostic Test:
• Comprehensive Ophthalmologic Examination
Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and anterior segment parameters,corneal topography

Locations

Country	Name	City	State
Turkey	Akdeniz University Hospital	Antalya	Konyaalti

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal thickness	Corneal thickness in mikrometer value	40 weeks
Primary	Anterior chamber volume	Anterior chamber volume in mm3	40 weeks
Primary	Anterior chamber depth	Anterior chamber depth in mm	40 weeks
Primary	Anterior chamber angle	Anterior chamber angle in degree	40 weeks
Primary	Lens power	in diopters	40 weeks
Primary	Anterior flat keratometry	in Diopters	40 weeks
Primary	Steep keratometry	in Diopters	40 weeks
Primary	Mean keratometry	in Diopters	40 weeks
Primary	Tonometry	Intraocular pressure measurement in mmHg	40 weeks
Primary	Best corrected visual acuity assessment	Snellen and logMAR chart	40 weeks
Primary	Blood pressure measurement	Systemic blood pressure	40 weeks
Primary	Auto refractometer	Refractive error measurement in diopter	40 weeks
Primary	Axial length	Axial length in mm	40 weeks