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Clinical Trials/NCT04950855
NCT04950855
Terminated
Not Applicable

Evaluation of Retinal and Choroidal Microvascular Structures: Comparison With Three Trimesters of Healthy Pregnant Women and Healthy Non-pregnant Women Using Optical Coherence Tomography Angiography

Akdeniz University1 site in 1 country86 target enrollmentJune 26, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Akdeniz University
Enrollment
86
Locations
1
Primary Endpoint
Choroidal thickness
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

During pregnancy many physiological changes and adaptations occur.Hormonal, hematological and hemodynamic changes are responsible for most of the ocular adaptations.We are planning to compare the choroid and retinal blood flow values and choroidal thickness of pregnant women and healthy non pregnant women with optical coherence tomography and optic coherence tomography angiography

Detailed Description

During pregnancy many physiological changes and adaptations occur such as pulmonary, renal, endocrinological, haematological and visual system changes are happening. In previous studies, retinal and choroidal pregnancy-related changes in blood flow and choroidal thickness have been demonstrated. Optical coherence tomography angiography (OCTA) detects the contrast of motion in the blood flow, detecting the capillary of the retina and choroid. It is a new functional method that visualizes the retinal networks and outer retina without using dyes.It is a non-invasive method that provides volumetric angiography information. In this study evaluation of the variability of choroidal and retinal blood flow changes and choroidal thickness, between trimesters of pregnancy and the non-pregnant control group is planned. Choroid and Retinal Blood Flow Values and Choroidal thickness in 41 pregnant women in the first trimester and it would be repeated at second and third trimesters. We compare measured values between trimesters and 45 healthy non-pregnant women.

Registry
clinicaltrials.gov
Start Date
June 26, 2021
End Date
November 1, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Çisil Erkan Pota

Medical Doctor

Akdeniz University

Eligibility Criteria

Inclusion Criteria

  • Healthy pregnant women Age \> 18 years

Exclusion Criteria

  • Systemical disease such as diabetes mellitus or hypertension
  • Refractive error; spherical equivalence \> 4 diopters
  • Ocular disease or surgery history

Outcomes

Primary Outcomes

Choroidal thickness

Time Frame: 40 weeks

Choroidal thickness is measured by optical coherence tomography

Retinal thickness

Time Frame: 40 weeks

Retinal thickness is measured by optical coherence tomography

Secondary Outcomes

  • Retinal nerve fiber layer thickness(40 weeks)
  • Retinal vascular density(40 weeks)
  • Foveal avascular zone(FAZ) area measurement(40 weeks)
  • Ganglion cell layer measurement(40 weeks)

Study Sites (1)

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