Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

Sponsor
Khon Kaen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04773574
Collaborator
(none)
30
1
48

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Physiologic Ocular Changes During Pregnancy in Women With High Myopia.
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Choroidal thickness [40 weeks]

    Choroidal thickness was measured by optical coherence tomography

Secondary Outcome Measures

  1. Retinal vascular density [40 weeks]

    Percentage of retinal vascular density was measured by optical coherence tomography angiography

  2. Retinal nerve fiber layer thickness [40 weeks]

    Retinal nerve fiber layer thickness was measured by optical coherence tomography

  3. Corneal thickness [40 weeks]

    Corneal thickness was measured by corneal topography

  4. Corneal curvature [40 weeks]

    Corneal curvature was measured by corneal topography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Khon Kaen University

Investigators

  • Principal Investigator: Suthasinee Sinawat, MD, KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suthasinee Sinawat, Associate Professor, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT04773574
Other Study ID Numbers:
  • HE631583
First Posted:
Feb 26, 2021
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Suthasinee Sinawat, Associate Professor, Khon Kaen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2021