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

NCT ID: NCT02024048

Last Updated: 2014-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant

OCT

OCT

Intervention Type OTHER

Optical coherence tomography in enhanced depth imaging mode

Control

OCT

OCT

Intervention Type OTHER

Optical coherence tomography in enhanced depth imaging mode

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OCT

Optical coherence tomography in enhanced depth imaging mode

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gaia Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Renata Rothwell

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Renata Rothwell, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Opthalmolgy, Centro Hospitalar Vila Nova de Gaia/Espinho

Sofia Fonseca, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho

Marisa Oliveira, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho

Lígia Ribeiro, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho

Dália Meira, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ECTP-EDI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Accuracy of Rail Sign at Detection of PAS
NCT07159997 NOT_YET_RECRUITING NA