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

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

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

Study Overview

• Status: Terminated
• Conditions: Pregnancy Related
• Intervention / Treatment: Diagnostic test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)

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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07070
    • Akdeniz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Retinal and choroid thickness and retinal angiographic values will be measured in healthy pregnant population (1 time for each trimester,totally 3 times) and healty control group

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon); Optical coherence tomography optical coherence tomography angiography; Other Names: Blood Pressure Measurement; Pachymetry; Otorefractometry; Tonometry
Control Group; Healty non-pregnant women between 18-45 years with no history of eye surgery and systemical disease.	Diagnostic test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon); Optical coherence tomography optical coherence tomography angiography; Other Names: Blood Pressure Measurement; Pachymetry; Otorefractometry; Tonometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choroidal thickness	Choroidal thickness is measured by optical coherence tomography	40 weeks
Retinal thickness	Retinal thickness is measured by optical coherence tomography	40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foveal avascular zone(FAZ) area measurement	FAZ area is measured by optical coherence tomography anjiography	40 weeks
Retinal vascular density	% of retinal vascular density is measured by optical coherence tomography angiography	40 weeks
Retinal nerve fiber layer thickness	Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography	40 weeks
Ganglion cell layer measurement	Ganglion cell layer measurement is measured by optical coherence tomography	40 weeks

Collaborators and Investigators

• Sponsor: Akdeniz University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2021
• Primary Completion (ACTUAL): November 1, 2021
• Study Completion (ACTUAL): November 1, 2021

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 26, 2021
• First Posted (ACTUAL): July 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; retina; Choroid; Tomography, Optical Coherence
• Other Study ID Numbers: Study1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No