Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

The prevalence of myopia is seemingly increasing, and it is one of the major causes of blindness. High myopia is defined as a refractive error with spherical equivalent exceeding -6 diopters and/or the axial length longer than 26.5 mm. The global prevalence of high myopia is estimated to rise from 2.7% of the world population in 2010 to 9.8% of the world population in 2050. High myopia is characterized by axial length elongation, and consequent stretching of the posterior eye wall (thin retina and choroid). There are many complications of high myopia such as posterior staphyloma, lacquer cracks and myopic choroidal neovascularization. Normal labour may cause the ocular complication in pregnant women with high myopia, such as macular hemorrhage. Therefore, the caesarean section with epidural anesthesia is recommended. Moreover, there is no standard screening guideline for pregnant women with high myopia.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; High Myopia
• Intervention / Treatment: Device: Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)

Detailed Description

There are few studies of posterior ocular changes during pregnancy. A recent meta-analysis showed that the choroidal thickness and retinal vascular density were increased during pregnancy especially in the 3rd trimester. From the literature review, there is only one publication of physiologic ocular changes during pregnancy in high myopia. Chen et al demonstrated that the choroidal thickness was increased significantly in the 3rd trimester. However, the changes of retinal vascular density in pregnant women with high myopia have never been studied before.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suthasinee S, MD; Phone Number: +66815454594; Email: ssuthasinee@kku.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age > 18 years
• high myopia: spherical equivalent > 6 diopters and/or axial length > 26.5 mm
• singleton pregnancy
• clear ocular media
• written inform consent

Exclusion Criteria:

• high risk pregnancy such as pre-eclampsia, gestational diabetes mellitus, hyperthyroidism and asthma.
• history of retinal diseases such as macular edema and retinal vascular occlusion
• history of intraocular inflammation or endophthalmitis
• history of intraocular laser treatment
• history of intraocular surgery

Withdrawal criteria

• childbirth before 34 weeks' gestation
• multifetal pregnancy was detected by ultrasound
• high risk pregnancy which could not follow the research protocol such as severe pre-eclampsia
• retinal diseases occur during the follow-up period such as central serous chorioretinopathy, retinal detachment and choroidal neovascularization
• significant ocular trauma during the follow-up period
• severe peripartum or postpartum complications such as thromboembolic disease and postpartum hemorrhage

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal pregnant women with high myopia; Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) were performed in each trimesters and at 6 weeks after childbirth.	Device: Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA); Ocular investigations 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choroidal thickness	Choroidal thickness was measured by optical coherence tomography	40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal vascular density	Percentage of retinal vascular density was measured by optical coherence tomography angiography	40 weeks
Retinal nerve fiber layer thickness	Retinal nerve fiber layer thickness was measured by optical coherence tomography	40 weeks
Corneal thickness	Corneal thickness was measured by corneal topography	40 weeks
Corneal curvature	Corneal curvature was measured by corneal topography	40 weeks

Collaborators and Investigators

• Sponsor: Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pregnancy; high myopia; choroidal thickness; retinal vascular density; retinal nerve fiber layer thickness; corneal curvature
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: HE631583

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No