NCT06311617

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress78%
Feb 2024Jan 2027

Study Start

First participant enrolled

February 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 27, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

March 2, 2024

Last Update Submit

April 23, 2025

Conditions

Pregnancy

Keywords

Optical coherence tomographyPregnancyImagingRetinaVascularFundus Photography

Outcome Measures

Primary Outcomes (3)

  • Imaging Biomarkers: Choroid

    Choroidal thickness

    during 9 months of pregnancy and in the 3 months after pregnancy

  • Imaging Biomarkers: Vessel density

    Vessel density

    during 9 months of pregnancy and in the 3 months after pregnancy

  • Imaging Biomarkers: Foveal avascular zone (FAZ)

    FAZ area

    during 9 months of pregnancy and in the 3 months after pregnancy

Secondary Outcomes (2)

  • Fetal Health: delivery

    at time of birth

  • Fetal Health

    at time of birth

Study Arms (3)

Healthy Pregnant Patients

Health pregnancies

Diagnostic Test: Optical coherence tomography

Pregnant Patients with Pre-Existing Diabetes

Patients with pre-existing diabetes who are pregnant

Diagnostic Test: Optical coherence tomography

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.

Diagnostic Test: Optical coherence tomography

Interventions

Optical coherence tomographyDIAGNOSTIC_TEST

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

Healthy Pregnant PatientsPregnant Patients with Pre-Existing DiabetesPregnant Patients with Vascular Disease or Risk Factors for Vascular Disease

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant patients (healthy and those with pre-existing diabetes/hypertension, and those with pregnancy-associated hypertension and diabetes or multiple gestations)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Avni P Finn, MD, MBA

    Vanderbilt Eye Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saige Priddy

CONTACT

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

Elise Timtim, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Director of Imaging

Study Record Dates

First Submitted

March 2, 2024

First Posted

March 15, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)