Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

NCT ID: NCT04773574

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2025-06-30

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.

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.

Conditions

High Myopia; Pregnancy Related

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Interventions

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.

1. st trimester : gestational age 8-12 weeks

2. nd trimester : gestational age 24-28 weeks

3. rd trimester : gestational age 34-38 weeks

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Suthasinee Sinawat

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suthasinee Sinawat, MD

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Suthasinee S, MD

Role: CONTACT

ssuthasinee@kku.ac.th

+66815454594

Other Identifiers

HE631583

Identifier Type: -

Identifier Source: org_study_id