Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

NCT04773574 | Unknown DMC

• 1 other identifier: HE631583
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

High Myopia; Pregnancy Related

Keywords

high myopia; pregnancy; choroidal thickness; retinal vascular density; retinal nerve fiber layer thickness; corneal curvature

Outcome Measures

Primary Outcomes (1)

• Choroidal thickness

  Choroidal thickness was measured by optical coherence tomography

  40 weeks

Secondary Outcomes (4)

• Retinal vascular density

  40 weeks

• Retinal nerve fiber layer thickness

  40 weeks

• Corneal thickness

  40 weeks

• Corneal curvature

  40 weeks

Study Arms (1)

Normal pregnant women with high myopia

EXPERIMENTAL

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)

Interventions

Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) DEVICE

Ocular investigations 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

Normal pregnant women with high myopia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

MeSH Terms

Interventions

Corneal Topography; Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Tomography; Investigative Techniques

Study Officials

• Suthasinee Sinawat, MD

  KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suthasinee S, MD

CONTACT

+66815454594; ssuthasinee@kku.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: February 26, 2021
• Study Start: July 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share