Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Diagnostic test: Comprehensive Ophthalmologic Examination

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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Konyaaltı
    • Antalya, Konyaaltı, Turkey, 07059
      • Akdeniz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Group; First trimester pregnant group would be included and will be followed up in second, third trimesters and after pregnancy	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; Other Names: Corneal Topography; Biometry; Auto refractometry; Non contact tonometry
Control group; Age-, sex-matched healthy volunteers	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; Other Names: Corneal Topography; Biometry; Auto refractometry; Non contact tonometry

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Principal Investigator: Çisil Erkan Pota, MD, Akdeniz University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 6, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Corneal Topography; Biometry; Anterior segment
• Other Study ID Numbers: Study 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No