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

• Conditions: Pregnancy
• Interventions: Other: OCT

• Registration Number: NCT02024048
• Lead Sponsor: Gaia Hospital

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-30
• Study First Posted: 2013-12-31
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-28
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 12

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	OCT	OCT
Pregnant	OCT	OCT

Primary Outcome Measures

Name	Time	Method
Choroidal thickness	3rd 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 Outcome Measures

Name	Time	Method
Change in choroidal thickness	During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum	Change in choroidal thickness in the third trimester of pregnancy and at 6 months post partum

Trial Locations

Locations (1)

Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova de Gaia; 🇵🇹 Vila Nova de Gaia, Portugal