Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

Conditions
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High Myopia, Pregnancy Related

Intervention / Treatment
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* Device: Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal pregnant women with high myopia<br>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)<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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choroidal thickness, retinal vascular density, retinal nerve fiber layer thickness, corneal curvature, high myopia, pregnancy