Retinal VascularNCT04731207
Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle
A study testing Optovue® in people with Retinal Vascular, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Changes of luteinizing hormone (LH), estrogen and progesterone during the menstrual cycle influence the ocular physiology in both anterior and posterior segments. From the literature review, there were no significant differentiation in tear physiology, anterior chamber dept, lens thickness and refractive status. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Retinal Vascular
- What is being tested?
- Optovue®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteThailand
- Study dates
- 3 Sep 2021to 30 Dec 2023
- 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 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female with age 25-40 yr
- Normal body mass index (18.5-24.9)
- Regular menstrual cycle (28-32 days)
- Written informed consent
Who cannot join
- Pregnant women
- Lactating women
- Having childbirth or miscarriage within 6 months
- Systemic diseases which need taking the regular medication
- History of ocular disease such as glaucoma, retinal vascular diseases and macular disease
- History of hormonal taking such as oral contraceptive pills within 6 months
Show all 12Show fewer
- History of intraocular laser and intraocular surgery
- Refractive error; spherical equivalent >4 diopters
- Can not taking the images by Optovue® such as spine diseases
- Withdrawal criteria
- Pregnancy detection during the study period
- Receiving sex hormone during the study period such as emergency contraceptive pills
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Khon Kaen University
Khon Kaen, 40000
Suthasinee Sinawat, MD, 0815454594, ssuthasinee@kku.ac.th
Suthasinee Sinawat, MD
About this study
Changes of luteinizing hormone (LH), estrogen and progesterone during the menstrual cycle influence the ocular physiology in both anterior and posterior segments. From the literature review, there were no significant differentiation in tear physiology, anterior chamber dept, lens thickness and refractive status. Some studies demonstrated then the central corneal thickness was thinner in the follicular phase, but this is non-conclusive. Advance in ophthalmic technologies provide few studies of posterior segment changes during the menstrual cycle, however, there were quite difference in methodology such as detection methods of ovulation.
Read the detailed description
There were 2 studies of posterior segment changes during the menstrual cycle. Akar et al showed significant decrease of neuroretinal rim area and increase of cupt area in late luteal phase. Ulas et al found that choroidal thickness was significant thicker in mid-luteal phase. However, the study of retinal vascular density by optical coherence tomography angiography (OCTA) during the menstrual cycle has never been published before.
- Conditions
- Retinal Vascular
- Being tested
- Optovue®
- Keywords
- retinal vascular density, choroidal thickness, optic nerve head, optical coherence tomography, optical coherence tomography angiography, menstrual cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optovue®Device
Optical coherence tomography and optical coherece tomography angiography
| Study group | Role | What they receive |
|---|---|---|
| Healthy pregnant women | Other | All participants will be investigated by Optovue® in follicular phase, ovulatory phase, luteal phase of menstrual cycle. The investigation will be done between 12 PM and 1 PM at each phase. Urine pregnancy testing was done at first and last visits. LH ovulation test was performed by the participants own. if the ovulation was detected by urine strip test, the participant have to underwent the Optovue® within 48 hours. Receives: Device: 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: 1 month
Secondary outcomes (3)
Choroidal thickness
Choroidal thickness (um) is measured by optical coherence tomography
Measured: 1 month
Retinal nerve fiber layer thickness
Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography
Measured: 1 month
Optic nerve head topography
Disc area and cup area (mm3) are measured by optical coherence tomography
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start3 Sep 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT04731207
- Sponsor's protocol ID
- HE631585
- Status last verified
- Oct 2023
- First submitted
- 23 Jan 2021
- Last updated
- 10 Oct 2023
- 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 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT04731207
- Acronym / sponsor ID
- HE631585
- Conditions
- Retinal Vascular
- Keywords
- retinal vascular density, choroidal thickness, optic nerve head, optical coherence tomography, optical coherence tomography angiography, menstrual cycle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 29 Jan 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.
Changes of luteinizing hormone (LH), estrogen and progesterone during the menstrual cycle influence the ocular physiology in both anterior and posterior segments. From the literature review, there were no significant differentiation in tear physiology, anterior chamber dept, lens thickness and refractive status. Some studies demonstrated then the central corneal thickness was thinner in the follicular phase, but this is non-conclusive. Advance in ophthalmic technologies provide few studies of posterior segment changes during the menstrual cycle, however, there were quite difference in methodology such as detection methods of ovulation.
Detailed description
There were 2 studies of posterior segment changes during the menstrual cycle. Akar et al showed significant decrease of neuroretinal rim area and increase of cupt area in late luteal phase. Ulas et al found that choroidal thickness was significant thicker in mid-luteal phase. However, the study of retinal vascular density by optical coherence tomography angiography (OCTA) during the menstrual cycle has never been published before.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnant women | Other | Device: Optovue®All participants will be investigated by Optovue® in follicular phase, ovulatory phase, luteal phase of menstrual cycle. The investigation will be done between 12 PM and 1 PM at each phase. Urine pregnancy testing was done at first and last visits. LH ovulation test was performed by the participants own. if the ovulation was detected by urine strip test, the participant have to underwent the Optovue® within 48 hours. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female with age 25-40 yr
- Normal body mass index (18.5-24.9)
- Regular menstrual cycle (28-32 days)
- Written informed consent
Key exclusion criteria (12 listed)
- Pregnant women
- Lactating women
- Having childbirth or miscarriage within 6 months
- Systemic diseases which need taking the regular medication
- History of ocular disease such as glaucoma, retinal vascular diseases and macular disease
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 |
|---|---|---|
| Optovue®Optical coherence tomography and optical coherece tomography angiography | Device | Healthy pregnant women |
Primary outcome
Retinal vascular density
Time frame: 1 month
% of retinal vascular density is measured by optical coherence tomography angiography
3 secondary outcomes
Choroidal thickness
Time frame: 1 month
Retinal nerve fiber layer thickness
Time frame: 1 month
Optic nerve head topography
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- 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 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 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 10 Oct 2023. 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: 1 month). 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 10 Oct 2023.