Retinal VascularNCT04731415
Physiologic Change of Posterior Ocular Segment During Pregnancy
A study testing Optical coherence tomography and optical coherence tomography angiography (Optovue®) in people with Retinal Vascular, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Women's physiology changes markedly during normal pregnancy. The most distinct alterations occur in the hormonal and cardiovascular systems. There is a dramatic increase in both estrogen and progesterone. Blood volume starts to increase in the first gestational period and reaches a peak in the third trimester. 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
- Retinal Vascular
- What is being tested?
- Optical coherence tomography and optical coherence tomography angiography (Optovue®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2021to 30 Jun 2026
- 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
- Healthy pregnant women
- Age > 18 years
- Gestational age < 12 weeks
- Written informed consent
Who cannot join
- High risk pregnancy such as multifetal pregnancy and preeclampsia
- History of vitreoretinal diseases such as retinal vasculitis
- History of intraocular laser treatments or intraocular surgeries
- History of systemic diseases such as diabetes mellitus and thyroid disease
- Refractive error; spherical equivalence > 4 diopters
- Clear ocular media
Show all 13Show fewer
- Could not be taken the images by non-dilated pupil
- Withdrawal Criteria:
- Preterm labor; gestational age < 34 weeks
- Multifetal pregnancy was demonstrated by ultrasound
- Severe labor and delivery complications such as
- Severe postpartum complications such as postpartum bleeding
- Taking hormone during the follow-up period
Trial locations and contacts
1 site in 1 country.
About this study
Women's physiology changes markedly during normal pregnancy. The most distinct alterations occur in the hormonal and cardiovascular systems. There is a dramatic increase in both estrogen and progesterone. Blood volume starts to increase in the first gestational period and reaches a peak in the third trimester.
The physiologic ocular changes during pregnancy are mainly the result of hormonal and blood volume increase, and then are usually marked in the third trimester.
Read the detailed description
Ocular anterior segment changes during pregnancy are the followings
- Melanogenesis of eyelid and facial skin -> melasma
- Cellular alteration of lacrimal and meibomian gland -> dry eye symptoms
- Increased corneal thickness and corneal curvature -> contact lens intolerance
- Increased lens thickness -> loss of accommodation
- Decreased intraocular pressure -> better glaucoma control There are few studies of posterior changes in pregnant women. Many limitations of previous publications includes lack of internal control and no data of postpartum contraception. However, choroidal thickness seems to be thicker in pregnant women than non-pregnant women. The other changes are non-inclusive.
- Conditions
- Retinal Vascular
- Being tested
- Optical coherence tomography and optical coherence tomography angiography (Optovue®)
- Keywords
- Retinal vascular density, Optical coherence tomography angiography, Choroidal thickness, Retinal nerve fiber layer thickness, Optic nerve head, Optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography and optical coherence tomography angiography (Optovue®)Device
Optical coherence tomography and optical coherence tomography angiography (Optovue®) 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 |
|---|---|---|
| Healthy pregnant women | Other | Optical coherence tomography and Optical coherence tomography angiography using Optovue® were performed in each trimester and at 6 weeks after childbirth. Receives: Device: Optical coherence tomography and optical coherence tomography angiography (Optovue®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal vascular density
% of retinal vascular density is measured by optical coherence tomography angiography
Measured: 40 weeks
Secondary outcomes (3)
Choroidal thickness
Choroidal thickness (um) is measured by optical coherence tomography
Measured: 40 weeks
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography
Measured: 40 weeks
Optic disc tomography
Cup area and disc area (mm3) are measured by optical coherence tomography
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 posted1 Feb 2021
- Study start1 Jul 2021 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal VascularStudies 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
- 69 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
- NCT04731415
- Sponsor's protocol ID
- HE631577
- Status last verified
- Jun 2021
- First submitted
- 24 Jan 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 Change of Posterior Ocular Segment During Pregnancy
- ClinicalTrials.gov ID
- NCT04731415
- Acronym / sponsor ID
- HE631577
- Conditions
- Retinal Vascular
- Keywords
- Retinal vascular density, Optical coherence tomography angiography, Choroidal thickness, Retinal nerve fiber layer thickness, Optic nerve head, Optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 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.
Women's physiology changes markedly during normal pregnancy. The most distinct alterations occur in the hormonal and cardiovascular systems. There is a dramatic increase in both estrogen and progesterone. Blood volume starts to increase in the first gestational period and reaches a peak in the third trimester.
The physiologic ocular changes during pregnancy are mainly the result of hormonal and blood volume increase, and then are usually marked in the third trimester.
Detailed description
Ocular anterior segment changes during pregnancy are the followings
- Melanogenesis of eyelid and facial skin -> melasma
- Cellular alteration of lacrimal and meibomian gland -> dry eye symptoms
- Increased corneal thickness and corneal curvature -> contact lens intolerance
- Increased lens thickness -> loss of accommodation
- Decreased intraocular pressure -> better glaucoma control There are few studies of posterior changes in pregnant women. Many limitations of previous publications includes lack of internal control and no data of postpartum contraception. However, choroidal thickness seems to be thicker in pregnant women than non-pregnant women. The other changes are non-inclusive.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women | Other | Device: Optical coherence tomography and optical coherence tomography angiography (Optovue®)Optical coherence tomography and Optical coherence tomography angiography using Optovue® were performed in each trimester 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 (4 listed)
- Healthy pregnant women
- Age > 18 years
- Gestational age < 12 weeks
- Written informed consent
Key exclusion criteria (13 listed)
- High risk pregnancy such as multifetal pregnancy and preeclampsia
- History of vitreoretinal diseases such as retinal vasculitis
- History of intraocular laser treatments or intraocular surgeries
- History of systemic diseases such as diabetes mellitus and thyroid disease
- Refractive error; spherical equivalence > 4 diopters
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 |
|---|---|---|
| Optical coherence tomography and optical coherence tomography angiography (Optovue®)Optical coherence tomography and optical coherence tomography angiography (Optovue®) 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 | Healthy pregnant women |
Primary outcome
Retinal vascular density
Time frame: 40 weeks
% of retinal vascular density is measured by optical coherence tomography angiography
3 secondary outcomes
Choroidal thickness
Time frame: 40 weeks
Retinal nerve fiber layer thickness
Time frame: 40 weeks
Optic disc tomography
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical coherence tomography and optical coherence tomography angiography (Optovue®) in people with Retinal Vascular, run by Khon Kaen University at 1 site in Thailand.
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 4 inclusion and 13 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.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Sinawat, MD (+66 81 5454594, ssuthasinee@kku.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal vascular density (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.