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

G

Gaia Hospital

Status

Unknown

Conditions

Pregnancy

Treatments

Other: OCT

Study type

Observational

Funder types

Other

Identifiers

NCT02024048
ECTP-EDI

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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

Trial design

12 participants in 2 patient groups

Pregnant
Description:
OCT
Treatment:
Other: OCT
Control
Description:
OCT
Treatment:
Other: OCT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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