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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04950855
• Other study ID #: Study1
• Status: Terminated
• Start date: June 26, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Diagnostic Test:
• Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)
Optical coherence tomography optical coherence tomography angiography

Locations

Country	Name	City	State
Turkey	Akdeniz University Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal thickness	Choroidal thickness is measured by optical coherence tomography	40 weeks
Primary	Retinal thickness	Retinal thickness is measured by optical coherence tomography	40 weeks
Secondary	Foveal avascular zone(FAZ) area measurement	FAZ area is measured by optical coherence tomography anjiography	40 weeks
Secondary	Retinal vascular density	% of retinal vascular density is measured by optical coherence tomography angiography	40 weeks
Secondary	Retinal nerve fiber layer thickness	Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography	40 weeks
Secondary	Ganglion cell layer measurement	Ganglion cell layer measurement is measured by optical coherence tomography	40 weeks