Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

Conditions
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Retinal Vascular

Intervention / Treatment
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* Device: Optovue®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy pregnant women<br>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. | Device: Optovue®<br>* Optical coherence tomography and optical coherece tomography angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal vascular density | % of retinal vascular density is measured by optical coherence tomography angiography | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal thickness | Choroidal thickness (um) is measured by optical coherence tomography | 1 month | 
| Retinal nerve fiber layer thickness | Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography | 1 month | 
| Optic nerve head topography | Disc area and cup area (mm3) are measured by optical coherence tomography | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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choroidal thickness, retinal vascular density, optic nerve head, optical coherence tomography, optical coherence tomography angiography, menstrual cycle