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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02024048
Enrollment
12
Registered
2013-12-31
Start date
2013-12-31
Completion date
2014-07-31
Last updated
2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Pregnancy, OCT, Enhanced depth imaging, Choroid

Brief summary

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

Detailed description

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.

Interventions

OTHEROCT

Optical coherence tomography in enhanced depth imaging mode

Sponsors

Gaia Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Choroidal thickness3rd trimester of pregnancy (from 28 weeks gestation to delivery)Comparison of choroidal thickness between the pregnant group of women and the age-matched group of control subjects

Secondary

MeasureTime frameDescription
Change in choroidal thicknessDuring the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partumChange in choroidal thickness in the third trimester of pregnancy and at 6 months post partum

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026