Physiologic Change of Posterior Ocular Segment During Pregnancy

Retinal Vascular Clinical Trial

Official title:

Physiologic Change of Posterior Ocular Segment During Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04731415
• Other study ID #: HE631577
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2021
• Source: Khon Kaen University
• Contact: Suthasinee Sinawat, MD
• Phone: +66 81 5454594
• Email: ssuthasinee[@]kku.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 69
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Vascular

Intervention

Device:
• Optical 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. st trimester : gestational age 8-12 weeks nd trimester : gestational age 24-28 weeks rd trimester : gestational age 34-38 weeks

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retinal vascular density	% of retinal vascular density is measured by optical coherence tomography angiography	40 weeks
Secondary	Choroidal thickness	Choroidal thickness (um) is measured by optical coherence tomography	40 weeks
Secondary	Retinal nerve fiber layer thickness	Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography	40 weeks
Secondary	Optic disc tomography	Cup area and disc area (mm3) are measured by optical coherence tomography	40 weeks