Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy

Sponsor
Akdeniz University (Other)
Overall Status
Completed
CT.gov ID
NCT05175729
Collaborator
(none)
100
1
8
12.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy
Actual Study Start Date :
Dec 1, 2021
Actual Primary Completion Date :
Aug 1, 2022
Actual Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Corneal thickness [40 weeks]

      Corneal thickness in mikrometer value

    2. Anterior chamber volume [40 weeks]

      Anterior chamber volume in mm3

    3. Anterior chamber depth [40 weeks]

      Anterior chamber depth in mm

    4. Anterior chamber angle [40 weeks]

      Anterior chamber angle in degree

    5. Lens power [40 weeks]

      in diopters

    6. Anterior flat keratometry [40 weeks]

      in Diopters

    7. Steep keratometry [40 weeks]

      in Diopters

    8. Mean keratometry [40 weeks]

      in Diopters

    9. Tonometry [40 weeks]

      İntraocular pressure measurement in mmHg

    10. Best corrected visual acuity assessment [40 weeks]

      Snellen and logMAR chart

    11. Blood pressure measurement [40 weeks]

      Systemic blood pressure

    12. Auto refractometer [40 weeks]

      Refractive error measurement in diopter

    13. Axial length [40 weeks]

      Axial length in mm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akdeniz University Hospital Antalya Konyaaltı Turkey 07059

    Sponsors and Collaborators

    • Akdeniz University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Çisil Erkan Pota, Medical Doctor, Akdeniz University
    ClinicalTrials.gov Identifier:
    NCT05175729
    Other Study ID Numbers:
    • Study 2
    First Posted:
    Jan 4, 2022
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Çisil Erkan Pota, Medical Doctor, Akdeniz University

    Study Results

    No Results Posted as of Aug 9, 2022