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Retinal Vascular Changes During Pregnancy

Understanding Retinal Vascular Changes During Pregnancy and the Impact on Maternal and Fetal Health

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06311617
Enrollment
90
Registered
2024-03-15
Start date
2024-02-01
Completion date
2027-01-01
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Optical coherence tomography, Pregnancy, Imaging, Retina, Vascular, Fundus Photography

Brief summary

The goal of this study is to better understand how the back part of the eye-called the retina and the choroid-changes during pregnancy. Specialized photos of the eye will be taken at three different timepoints: early in pregnancy (first or second trimester), late in pregnancy (third trimester), and after delivery. This imaging is non-invasive and does not require contact with the surface of the eye. The photos taken will allow assessment of specific parameters, like blood flow and the health of specialized cells that support vision. Understanding how the eyes change during pregnancy may help guide how retina specialists understanding of retinal disease during pregnancy and better inform pregnancy outcomes.

Detailed description

Pregnancy is a unique human condition marked by changes throughout the body, including changes in hormone levels, blood volume, blood pressure, and blood clot formation. These changes impact the eye as well, particularly the back part of the eye, called the retina and the choroid. Pre-existing conditions like diabetes and high blood pressure are known to affect the retina, but this impact may be increased by during pregnancy. In addition, new eye conditions may develop. The purpose of this study is to better understand how the retina and choroid changes during pregnancy.

Interventions

DIAGNOSTIC_TESTOptical coherence tomography

Non-mydriatic fundus photography and optical coherence tomography will be performed at 3 timepoints

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

Inclusion criteria

1. Patient age 18 years and older 2. Patient able to provide informed consent 3. Pregnant at time of enrollment and in the 1st or 2nd trimester of pregnancy

Exclusion criteria

1. Other ocular disease that prevents imaging (significant cataract or other media opacity) 2. Unable to comply with imaging or follow-up through duration of study

Design outcomes

Primary

MeasureTime frameDescription
Imaging Biomarkers: Choroidduring 9 months of pregnancy and in the 3 months after pregnancyChoroidal thickness
Imaging Biomarkers: Vessel densityduring 9 months of pregnancy and in the 3 months after pregnancyVessel density
Imaging Biomarkers: Foveal avascular zone (FAZ)during 9 months of pregnancy and in the 3 months after pregnancyFAZ area

Secondary

MeasureTime frameDescription
Fetal Health: deliveryat time of birthModality of delivery
Fetal Healthat time of birthweight of baby at birth

Countries

United States

Contacts

CONTACTSaige Priddy
saige.priddy@vumc.org615-936-2020
CONTACTElise Timtim, MD
elise.timtim@vumc.org615-936-2020
PRINCIPAL_INVESTIGATORAvni P Finn, MD, MBA

Vanderbilt Eye Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026