Clinical trial NCT02024048: Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography
Official title: Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Pregnancy
OCT
Enhanced depth imaging
Choroid
Lead sponsor: Gaia Hospital
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 12
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women in the third trimester of pregnancy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Choroidal thickness
timeFrame: 3rd trimester of pregnancy (from 28 weeks gestation to delivery)
Secondary outcomes:
measure: Change in choroidal thickness
timeFrame: During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum
Other outcomes:
Locations:
city: Vila Nova de Gaia
country: Portugal
facility: Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova de Gaia
Study officials:
affiliation: Department of Opthalmolgy, Centro Hospitalar Vila Nova de Gaia/Espinho
name: Renata Rothwell, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
name: Sofia Fonseca, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
name: Marisa Oliveira, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
name: Lígia Ribeiro, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
name: Dália Meira, Dr
role: PRINCIPAL_INVESTIGATOR
References: