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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02024048
• Other study ID #: ECTP-EDI
• Status: Active, not recruiting
• Phase: N/A
• First received: December 18, 2013
• Last updated: January 27, 2014
• Start date: December 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2014
• Source: Gaia Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• OCT
Optical coherence tomography in enhanced depth imaging mode

Locations

Country	Name	City	State
Portugal	Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova de Gaia	Vila Nova de Gaia

Sponsors (1)

Lead Sponsor	Collaborator
Gaia Hospital

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Choroidal thickness	Comparison of choroidal thickness between the pregnant group of women and the age-matched group of control subjects	3rd trimester of pregnancy (from 28 weeks gestation to delivery)	No
Secondary	Change in choroidal thickness	Change in choroidal thickness in the third trimester of pregnancy and at 6 months post partum	During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum	No