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Physiologic Ocular Changes During Pregnancy in Women With High Myopia.

Primary Purpose

High Myopia, Pregnancy Related

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for High Myopia focused on measuring high myopia, pregnancy, choroidal thickness, retinal vascular density, retinal nerve fiber layer thickness, corneal curvature

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Normal pregnant women with high myopia

    Arm Description

    Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) were performed in each trimesters and at 6 weeks after childbirth.

    Outcomes

    Primary Outcome Measures

    Choroidal thickness
    Choroidal thickness was measured by optical coherence tomography

    Secondary Outcome Measures

    Retinal vascular density
    Percentage of retinal vascular density was measured by optical coherence tomography angiography
    Retinal nerve fiber layer thickness
    Retinal nerve fiber layer thickness was measured by optical coherence tomography
    Corneal thickness
    Corneal thickness was measured by corneal topography
    Corneal curvature
    Corneal curvature was measured by corneal topography

    Full Information

    First Posted
    February 25, 2021
    Last Updated
    June 29, 2021
    Sponsor
    Khon Kaen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04773574
    Brief Title
    Physiologic Ocular Changes During Pregnancy in Women With High Myopia.
    Official Title
    Physiologic Ocular Changes During Pregnancy in Women With High Myopia.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2021 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Khon Kaen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High Myopia, Pregnancy Related
    Keywords
    high myopia, pregnancy, choroidal thickness, retinal vascular density, retinal nerve fiber layer thickness, corneal curvature

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal pregnant women with high myopia
    Arm Type
    Experimental
    Arm Description
    Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) were performed in each trimesters and at 6 weeks after childbirth.
    Intervention Type
    Device
    Intervention Name(s)
    Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Choroidal thickness
    Description
    Choroidal thickness was measured by optical coherence tomography
    Time Frame
    40 weeks
    Secondary Outcome Measure Information:
    Title
    Retinal vascular density
    Description
    Percentage of retinal vascular density was measured by optical coherence tomography angiography
    Time Frame
    40 weeks
    Title
    Retinal nerve fiber layer thickness
    Description
    Retinal nerve fiber layer thickness was measured by optical coherence tomography
    Time Frame
    40 weeks
    Title
    Corneal thickness
    Description
    Corneal thickness was measured by corneal topography
    Time Frame
    40 weeks
    Title
    Corneal curvature
    Description
    Corneal curvature was measured by corneal topography
    Time Frame
    40 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suthasinee S, MD
    Phone
    +66815454594
    Email
    ssuthasinee@kku.ac.th
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suthasinee Sinawat, MD
    Organizational Affiliation
    KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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