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Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04731207
Enrollment
39
Registered
2021-01-29
Start date
2021-09-03
Completion date
2023-12-30
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Vascular

Keywords

retinal vascular density, choroidal thickness, optic nerve head, optical coherence tomography, optical coherence tomography angiography, menstrual cycle

Brief 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. 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.

Interventions

DEVICEOptovue®

Optical coherence tomography and optical coherece tomography angiography

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Female with age 25-40 yr * Normal body mass index (18.5-24.9) * Regular menstrual cycle (28-32 days) * Written informed consent

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Retinal vascular density1 month% of retinal vascular density is measured by optical coherence tomography angiography

Secondary

MeasureTime frameDescription
Choroidal thickness1 monthChoroidal thickness (um) is measured by optical coherence tomography
Retinal nerve fiber layer thickness1 monthRetinal nerve fiber layer thickness (um) is measured by optical coherence tomography
Optic nerve head topography1 monthDisc area and cup area (mm3) are measured by optical coherence tomography

Countries

Thailand

Contacts

Primary ContactSuthasinee Sinawat, MD
ssuthasinee@kku.ac.th+66 81 5454594

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026