Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography
1 other identifier
observational
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJanuary 28, 2014
January 1, 2014
1 month
December 18, 2013
January 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (1)
Change in choroidal thickness
During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum
Study Arms (2)
Pregnant
OCT
Control
OCT
Interventions
Eligibility Criteria
Healthy pregnant women in the third trimester of pregnancy
You may qualify if:
- 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)
You may not qualify if:
- any of the above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gaia Hospitallead
Study Sites (1)
Department of Ophthalmology, Centro Hospitalar Vila Nova de Gaia/Espinho Vila Nova de Gaia
Vila Nova de Gaia, Portugal
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 18, 2013
First Posted
December 31, 2013
Study Start
December 1, 2013
Primary Completion
January 1, 2014
Study Completion
July 1, 2014
Last Updated
January 28, 2014
Record last verified: 2014-01