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Retinal and Choroidal Microvascular Changes During Pregnancy Period Detected With Optical Coherence Tomography Angiography

NCT ID: NCT04950855

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-26

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Pregnancy Related

Keywords

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Pregnancy Tomography, Optical Coherence Choroid retina

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women

Healty pregnant women between 18-45 years,with no history of eye surgery and systemical disease.In 1st , 2nd and 3rd trimesters the measurements will be repeated

Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)

Intervention Type DIAGNOSTIC_TEST

Optical coherence tomography optical coherence tomography angiography

Control Group

Healty non-pregnant women between 18-45 years with no history of eye surgery and systemical disease.

Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)

Intervention Type DIAGNOSTIC_TEST

Optical coherence tomography optical coherence tomography angiography

Interventions

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Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)

Optical coherence tomography optical coherence tomography angiography

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Pachymetry Otorefractometry Tonometry Blood Pressure Measurement

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Çisil Erkan Pota

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akdeniz University Hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Study1

Identifier Type: -

Identifier Source: org_study_id