Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy

NCT ID: NCT05175729

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-08-01

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

Conditions

Pregnancy Related

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant Group

First trimester pregnant group would be included and will be followed up in second, third trimesters and after pregnancy

Comprehensive Ophthalmologic Examination

Intervention Type: DIAGNOSTIC_TEST

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

Control group

Age-, sex-matched healthy volunteers

Comprehensive Ophthalmologic Examination

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Corneal Topography; Biometry; Auto refractometry; Non contact tonometry

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Çisil Erkan Pota

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Çisil Erkan Pota, MD

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University Hospital

Locations

Akdeniz University Hospital

Antalya, Konyaaltı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Study 2

Identifier Type: -

Identifier Source: org_study_id