Comparing Anterior Segment Parameters During Pregnancy and Post-Pregnancy

NCT05175729 | Completed DMC

• 1 other identifier: Study 2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy Related

Keywords

Pregnancy; Anterior segment; Corneal Topography; Biometry

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (2)

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

Control group

Age-, sex-matched healthy volunteers

Diagnostic Test: Comprehensive Ophthalmologic Examination

Interventions

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

Also known as: Corneal Topography, Biometry, Auto refractometry, Non contact tonometry

Control group; Pregnant Group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, Konyaaltı, 07059, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Corneal Topography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Çisil Erkan Pota, MD

  Akdeniz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 4, 2022
• Study Start: December 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)