Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography
NCT ID: NCT02024048
Last Updated: 2014-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
12 participants
OBSERVATIONAL
2013-12-31
2014-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Pregnant
OCT
OCT
Optical coherence tomography in enhanced depth imaging mode
Control
OCT
OCT
Optical coherence tomography in enhanced depth imaging mode
Interventions
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OCT
Optical coherence tomography in enhanced depth imaging mode
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
Yes
Sponsors
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Gaia Hospital
OTHER
Responsible Party
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Renata Rothwell
Dr
Principal Investigators
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Renata Rothwell, Dr
Role: PRINCIPAL_INVESTIGATOR
Department of Opthalmolgy, Centro Hospitalar Vila Nova de Gaia/Espinho
Sofia Fonseca, Dr
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
Marisa Oliveira, Dr
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
Lígia Ribeiro, Dr
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
Dália Meira, Dr
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
Locations
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Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova de Gaia
Vila Nova de Gaia, , Portugal
Countries
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Other Identifiers
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ECTP-EDI
Identifier Type: -
Identifier Source: org_study_id
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