High MyopiaNCT04773574
Physiologic Ocular Changes During Pregnancy in Women With High Myopia.
A study testing Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) in people with High Myopia and Pregnancy Related, run by Khon Kaen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- High Myopia, Pregnancy Related
- What is being tested?
- Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age > 18 years
- high myopia: spherical equivalent > 6 diopters and/or axial length > 26.5 mm
- singleton pregnancy
- clear ocular media
- written inform consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)
- Keywords
- high myopia, pregnancy, choroidal thickness, retinal vascular density, retinal nerve fiber layer thickness, corneal curvature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Normal pregnant women with high myopia | Experimental | Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) were performed in each trimesters and at 6 weeks after childbirth. Receives: Device: Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Choroidal thickness was measured by optical coherence tomography
Measured: 40 weeks
Secondary outcomes (4)
Retinal vascular density
Percentage of retinal vascular density was measured by optical coherence tomography angiography
Measured: 40 weeks
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness was measured by optical coherence tomography
Measured: 40 weeks
Corneal thickness
Corneal thickness was measured by corneal topography
Measured: 40 weeks
Corneal curvature
Corneal curvature was measured by corneal topography
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suthasinee Sinawat, Khon Kaen University
- Investigators
- Suthasinee Sinawat, MD, Principal investigator, KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773574
- Sponsor's protocol ID
- HE631583
- Status last verified
- Jun 2021
- First submitted
- 25 Feb 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Ocular Changes During Pregnancy in Women With High Myopia.
- ClinicalTrials.gov ID
- NCT04773574
- Acronym / sponsor ID
- HE631583
- Conditions
- High Myopia, Pregnancy Related
- Keywords
- high myopia, pregnancy, choroidal thickness, retinal vascular density, retinal nerve fiber layer thickness, corneal curvature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal pregnant women with high myopia | Experimental | Device: Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) were performed in each trimesters and at 6 weeks after childbirth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age > 18 years
- high myopia: spherical equivalent > 6 diopters and/or axial length > 26.5 mm
- singleton pregnancy
- clear ocular media
- written inform consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Normal pregnant women with high myopia |
Primary outcome
Choroidal thickness
Time frame: 40 weeks
Choroidal thickness was measured by optical coherence tomography
4 secondary outcomes
Retinal vascular density
Time frame: 40 weeks
Retinal nerve fiber layer thickness
Time frame: 40 weeks
Corneal thickness
Time frame: 40 weeks
Corneal curvature
Time frame: 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suthasinee Sinawat, MD principal investigator
KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
Questions about this trial
What is this clinical trial studying?
A study testing Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA) in people with High Myopia and Pregnancy Related, run by Khon Kaen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suthasinee S, MD (+66815454594, ssuthasinee@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal thickness (time frame: 40 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.