Physiologic Change of Posterior Ocular Segment During Pregnancy

Sponsor

Khon Kaen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04731415

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vascular	Device: Optical coherence tomography and optical coherence tomography angiography (Optovue®)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

69 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Physiologic Change of Posterior Ocular Segment During Pregnancy

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy pregnant women Optical coherence tomography and Optical coherence tomography angiography using Optovue® were performed in each trimester and at 6 weeks after childbirth.	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

Arm

Intervention/Treatment

Other: Healthy pregnant women

Optical coherence tomography and Optical coherence tomography angiography using Optovue® were performed in each trimester and at 6 weeks after childbirth.

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

Outcome Measures

Primary Outcome Measures

Retinal vascular density [40 weeks]
% of retinal vascular density is measured by optical coherence tomography angiography

Secondary Outcome Measures

Choroidal thickness [40 weeks]
Choroidal thickness (um) is measured by optical coherence tomography
Retinal nerve fiber layer thickness [40 weeks]
Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography
Optic disc tomography [40 weeks]
Cup area and disc area (mm3) are measured by optical coherence tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Khon Kaen University	Khon Kaen		Thailand	40002

Sponsors and Collaborators

Khon Kaen University

Investigators

Principal Investigator: Suthasinee Sinawat, MD, KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suthasinee Sinawat, Associate Professor, Khon Kaen University

ClinicalTrials.gov Identifier:

NCT04731415

Other Study ID Numbers:

HE631577

First Posted:

Feb 1, 2021

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Suthasinee Sinawat, Associate Professor, Khon Kaen University

Retinal vascular density

Optical coherence tomography angiography

Choroidal thickness

Retinal nerve fiber layer thickness

Optic nerve head

Optical coherence tomography

Study Results

No Results Posted as of Jun 30, 2021