Physiologic Change of Posterior Ocular Segment During Pregnancy

Study Overview
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Brief Summary
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Women's physiology changes markedly during normal pregnancy. The most distinct alterations occur in the hormonal and cardiovascular systems. There is a dramatic increase in both estrogen and progesterone. Blood volume starts to increase in the first gestational period and reaches a peak in the third trimester. The physiologic ocular changes during pregnancy are mainly the result of hormonal and blood volume increase, and then are usually marked in the third trimester.

Detailed Description
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Ocular anterior segment changes during pregnancy are the followings Melanogenesis of eyelid and facial skin -> melasma Cellular alteration of lacrimal and meibomian gland -> dry eye symptoms Increased corneal thickness and corneal curvature -> contact lens intolerance Increased lens thickness -> loss of accommodation Decreased intraocular pressure -> better glaucoma control There are few studies of posterior changes in pregnant women. Many limitations of previous publications includes lack of internal control and no data of postpartum contraception. However, choroidal thickness seems to be thicker in pregnant women than non-pregnant women. The other changes are non-inclusive.

Official Title
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Physiologic Change of Posterior Ocular Segment During Pregnancy

Conditions
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Retinal Vascular

Intervention / Treatment
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* Device: Optical coherence tomography and optical coherence tomography angiography (Optovue®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy pregnant women Age > 18 years Gestational age < 12 weeks Written informed consent Exclusion Criteria: High risk pregnancy such as multifetal pregnancy and preeclampsia History of vitreoretinal diseases such as retinal vasculitis History of intraocular laser treatments or intraocular surgeries History of systemic diseases such as diabetes mellitus and thyroid disease Refractive error; spherical equivalence > 4 diopters Clear ocular media Could not be taken the images by non-dilated pupil Withdrawal Criteria: Preterm labor; gestational age < 34 weeks Multifetal pregnancy was demonstrated by ultrasound Severe labor and delivery complications such as Severe postpartum complications such as postpartum bleeding Taking hormone during the follow-up period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy pregnant women<br>Optical coherence tomography and Optical coherence tomography angiography using Optovue® were performed in each trimester and at 6 weeks after childbirth. | Device: Optical coherence tomography and optical coherence tomography angiography (Optovue®)<br>* Optical coherence tomography and optical coherence tomography angiography (Optovue®) were performed in each trimesters and at 6 weeks after childbirth. st trimester : gestational age 8-12 weeks nd trimester : gestational age 24-28 weeks rd trimester : gestational age 34-38 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal vascular density | % of retinal vascular density is measured by optical coherence tomography angiography | 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal thickness | Choroidal thickness (um) is measured by optical coherence tomography | 40 weeks | 
| Retinal nerve fiber layer thickness | Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography | 40 weeks | 
| Optic disc tomography | Cup area and disc area (mm3) are measured by optical coherence tomography | 40 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinal vascular density, Optical coherence tomography angiography, Choroidal thickness, Retinal nerve fiber layer thickness, Optic nerve head, Optical coherence tomography