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Physiologic Change of Posterior Ocular Segment During Pregnancy

Physiologic Change of Posterior Ocular Segment During Pregnancy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04731415
Enrollment
69
Registered
2021-02-01
Start date
2021-07-01
Completion date
2026-06-30
Last updated
2021-06-30

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

Conditions

Retinal Vascular

Keywords

Retinal vascular density, Optical coherence tomography angiography, Choroidal thickness, Retinal nerve fiber layer thickness, Optic nerve head, Optical coherence tomography

Brief summary

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.

Detailed description

Ocular anterior segment changes during pregnancy are the followings * Melanogenesis of eyelid and facial skin -\> melasma * Cellular alteration of lacrimal and meibomian gland -\> dry eye symptoms * Increased corneal thickness and corneal curvature -\> contact lens intolerance * Increased lens thickness -\> loss of accommodation * Decreased intraocular pressure -\> better glaucoma control There are few studies of posterior changes in pregnant women. Many limitations of previous publications includes lack of internal control and no data of postpartum contraception. However, choroidal thickness seems to be thicker in pregnant women than non-pregnant women. The other changes are non-inclusive.

Interventions

DEVICEOptical coherence tomography and optical coherence tomography angiography (Optovue®)

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

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy pregnant women * Age \> 18 years * Gestational age \< 12 weeks * Written informed consent

Exclusion criteria

* 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 * Refractive error; spherical equivalence \> 4 diopters * Clear ocular media * Could not be taken the images by non-dilated pupil Withdrawal Criteria: * Preterm labor; gestational age \< 34 weeks * Multifetal pregnancy was demonstrated by ultrasound * Severe labor and delivery complications such as * Severe postpartum complications such as postpartum bleeding * Taking hormone during the follow-up period

Design outcomes

Primary

MeasureTime frameDescription
Retinal vascular density40 weeks% of retinal vascular density is measured by optical coherence tomography angiography

Secondary

MeasureTime frameDescription
Choroidal thickness40 weeksChoroidal thickness (um) is measured by optical coherence tomography
Retinal nerve fiber layer thickness40 weeksRetinal nerve fiber layer thickness (um) is measured by optical coherence tomography
Optic disc tomography40 weeksCup area and disc area (mm3) are measured by optical coherence tomography

Countries

Thailand

Contacts

Primary ContactSuthasinee Sinawat, MD
ssuthasinee@kku.ac.th+66 81 5454594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026