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

Terminated

• Conditions: Pregnancy Related
• Interventions: Diagnostic Test: Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)

• Registration Number: NCT04950855
• Lead Sponsor: Akdeniz University

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.

Study Timeline

• Study First Submitted: 2021-06-24
• Study Start: 2021-06-26
• Study First Submitted QC: 2021-06-26
• Study First Posted: 2021-07-06
• Status Verified: 2021-11
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Last Update Submitted: 2021-11-01
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 86

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant Women	Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)	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
Control Group	Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)	Healty non-pregnant women between 18-45 years with no history of eye surgery and systemical disease.

Primary Outcome Measures

Name	Time	Method
Choroidal thickness	40 weeks	Choroidal thickness is measured by optical coherence tomography
Retinal thickness	40 weeks	Retinal thickness is measured by optical coherence tomography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Akdeniz University Hospital; 🇹🇷 Antalya, Turkey