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Completed

NCT Number: NCT05175729

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

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Key information

Conditions

Pregnancy Related

Age range

19 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Akdeniz University Hospital

Antalya, Konyaaltı, 07059, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive ophthalmologic examination

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

Other names: Corneal Topography, Biometry, Auto refractometry, Non contact tonometry

Primary outcomes

  1. Corneal thickness

    Time frame: 40 weeks

    Corneal thickness in mikrometer value

  2. Anterior chamber volume

    Time frame: 40 weeks

    Anterior chamber volume in mm3

  3. Anterior chamber depth

    Time frame: 40 weeks

    Anterior chamber depth in mm

  4. Anterior chamber angle

    Time frame: 40 weeks

    Anterior chamber angle in degree

  5. Lens power

    Time frame: 40 weeks

    in diopters

  6. Anterior flat keratometry

    Time frame: 40 weeks

    in Diopters

  7. Steep keratometry

    Time frame: 40 weeks

    in Diopters

  8. Mean keratometry

    Time frame: 40 weeks

    in Diopters

  9. Tonometry

    Time frame: 40 weeks

    İntraocular pressure measurement in mmHg

  10. Best corrected visual acuity assessment

    Time frame: 40 weeks

    Snellen and logMAR chart

  11. Blood pressure measurement

    Time frame: 40 weeks

    Systemic blood pressure

  12. Auto refractometer

    Time frame: 40 weeks

    Refractive error measurement in diopter

  13. Axial length

    Time frame: 40 weeks

    Axial length in mm

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2022
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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