We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Renata Rothwell, Gaia Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02024048
First Posted: December 31, 2013
Last Update Posted: January 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Renata Rothwell, Gaia Hospital
  Purpose
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

Condition Intervention
Pregnancy Other: OCT

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Renata Rothwell, Gaia Hospital:

Primary Outcome Measures:
  • Choroidal thickness [ Time Frame: 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:
  • Change in choroidal thickness [ Time Frame: 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


Enrollment: 12
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant
OCT
Other: OCT
Optical coherence tomography in enhanced depth imaging mode
Control
OCT
Other: OCT
Optical coherence tomography in enhanced depth imaging mode

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant women in the third trimester of pregnancy
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024048


Locations
Portugal
Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova de Gaia
Vila Nova de Gaia, Portugal
Sponsors and Collaborators
Gaia Hospital
Investigators
Principal Investigator: Renata Rothwell, Dr Department of Opthalmolgy, Centro Hospitalar Vila Nova de Gaia/Espinho
Principal Investigator: Sofia Fonseca, Dr Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
Principal Investigator: Marisa Oliveira, Dr Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
Principal Investigator: Lígia Ribeiro, Dr Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
Principal Investigator: Dália Meira, Dr Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho
  More Information

Responsible Party: Renata Rothwell, Dr, Gaia Hospital
ClinicalTrials.gov Identifier: NCT02024048     History of Changes
Other Study ID Numbers: ECTP-EDI
First Submitted: December 18, 2013
First Posted: December 31, 2013
Last Update Posted: January 28, 2014
Last Verified: January 2014

Keywords provided by Renata Rothwell, Gaia Hospital:
Pregnancy
OCT
Enhanced depth imaging
Choroid