Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography

N/AUnknownNCT02024048

Gaia Hospital12 enrolled

Overview

The purpose of this study is to evaluate choroidal thickness and volume during the third trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group of women

Pregnant women in the last trimester and age-matched healthy controls have an Optical Coherence Tomography (OCT) image taken on the OCT Spectralis® device. A map of the choroid in the macular area is constructed automatically. Choroidal thickness and volume are calculated for the 9 subfields defined by the Early Treatment Diabetic Retinopathy Study (ETDRS). A comparative analysis between the two groups will be performed. As a secondary outcome measure, the change in choroidal thickness of the pregnant group of women will be assessed at 6 months postpartum by comparison to the 3rd trimester of pregnancy. The OCT is a non-invasive examination that poses no risk to the mother or the fetus.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregnancy

Interventions

OCTOTHER

Optical coherence tomography in enhanced depth imaging mode

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Pregnant women: * uncomplicated pregnancy in the third trimester (from 28 weeks of gestation) For both groups: * no systemic or ocular disease * absence of systemic medication other than prenatal vitamins * no smoking habits * emmetropia or a small refractive error (spherical equivalent \<1.5 diopters) Exclusion Criteria: * any of the above

Locations (1)

Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova de Gaia

Vila Nova de Gaia, Portugal

Outcomes

Primary Outcomes

Choroidal thickness

Comparison of choroidal thickness between the pregnant group of women and the age-matched group of control subjects

Time frame: 3rd trimester of pregnancy (from 28 weeks gestation to delivery)

Secondary Outcomes

Change in choroidal thickness

Change in choroidal thickness in the third trimester of pregnancy and at 6 months post partum

Time frame: During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum

Data from ClinicalTrials.gov

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