Health TrialsbyHealthPanel

Physiologic Change of Posterior Ocular Segment During Pregnancy

ConditionRetinal Vascular
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorKhon Kaen University

About this trial

Women's physiology changes markedly during normal pregnancy. The most distinct alterations occur in the hormonal and cardiovascular systems. There is a dramatic increase in both estrogen and progesterone. Blood volume starts to increase in the first gestational period and reaches a peak in the third trimester.

The physiologic ocular changes during pregnancy are mainly the result of hormonal and blood volume increase, and then are usually marked in the third trimester.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy pregnant women

Age > 18 years

Gestational age < 12 weeks

Written informed consent

Disqualifiers

High risk pregnancy such as multifetal pregnancy and preeclampsia

History of vitreoretinal diseases such as retinal vasculitis

History of intraocular laser treatments or intraocular surgeries

History of systemic diseases such as diabetes mellitus and thyroid disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Optical coherence tomography and optical coherence tomography angiography (Optovue®)

    Device

    Optical coherence tomography and optical coherence tomography angiography (Optovue®) were performed in each trimesters and at 6 weeks after childbirth. 1. st trimester : gestational age 8-12 weeks 2. nd trimester : gestational age 24-28 weeks 3. rd trimester : gestational age 34-38 weeks

Treatment groups

69 Participants
are divided into 1 treatment group
Group A: Healthy pregnant womenOther 1 intervention

Trial outcomes

Primary outcomes

1

Retinal vascular density

% of retinal vascular density is measured by optical coherence tomography angiography

Time frame
40 weeks

Secondary outcomes

1

Choroidal thickness

Choroidal thickness (um) is measured by optical coherence tomography

Time frame
40 weeks
2

Retinal nerve fiber layer thickness

Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography

Time frame
40 weeks
3

Optic disc tomography

Cup area and disc area (mm3) are measured by optical coherence tomography

Time frame
40 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Khon Kaen University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: