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Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04773574
Enrollment
30
Registered
2021-02-26
Start date
2021-07-01
Completion date
2025-06-30
Last updated
2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Myopia, Pregnancy Related

Keywords

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

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.

Interventions

DEVICECorneal 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

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Choroidal thickness40 weeksChoroidal thickness was measured by optical coherence tomography

Secondary

MeasureTime frameDescription
Retinal vascular density40 weeksPercentage of retinal vascular density was measured by optical coherence tomography angiography
Retinal nerve fiber layer thickness40 weeksRetinal nerve fiber layer thickness was measured by optical coherence tomography
Corneal thickness40 weeksCorneal thickness was measured by corneal topography
Corneal curvature40 weeksCorneal curvature was measured by corneal topography

Contacts

Primary ContactSuthasinee S, MD
ssuthasinee@kku.ac.th+66815454594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026