Recruiting

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06311617

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Optical coherence tomography

Study Details

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.

Conditions

Pregnancy

Study ID

NCT06311617

Start date

Feb 1, 2024

Status verified date

May, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Pregnant Patients

Health pregnancies

Pregnant Patients with Pre-Existing Diabetes

Patients with pre-existing diabetes who are pregnant

Pregnant Patients with Vascular Disease or Risk Factors for Vascular Disease

1. Multiple gestations
2. Preeclampsia or eclampsia
3. Gestational diabetes
4. Hypercoagulable state such as disseminated intravascular coagulation (DIC), thrombotic thrombocytopenic purpura (TTP), and hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome.

Interventions

Optical coherence tomography

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

Primary outcome measure

  • Imaging Biomarkers: Choroid [ Time Frame: during 9 months of pregnancy and in the 3 months after pregnancy ]
  • Imaging Biomarkers: Vessel density [ Time Frame: during 9 months of pregnancy and in the 3 months after pregnancy ]
  • Imaging Biomarkers: Foveal avascular zone (FAZ) [ Time Frame: during 9 months of pregnancy and in the 3 months after pregnancy ]

Central Contacts and Locations

Central contacts

Saige Priddy

615-936-2020saige.priddy@vumc.org

Elise Timtim, MD

615-936-2020elise.timtim@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Avni Finn, MD, MBA

615-936-1639

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-05-08.