Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

Not Applicable

Recruiting

• Conditions: Retinal Vascular
• Interventions: Device: Optovue®

• Registration Number: NCT04731207
• Lead Sponsor: Khon Kaen University

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.

Study Timeline

• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-09-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-10
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy pregnant women	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.

Primary Outcome Measures

Name	Time	Method
Retinal vascular density	1 month	% of retinal vascular density is measured by optical coherence tomography angiography

Secondary Outcome Measures

Name	Time	Method
Choroidal thickness	1 month	Choroidal thickness (um) is measured by optical coherence tomography
Optic nerve head topography	1 month	Disc area and cup area (mm3) are measured by optical coherence tomography
Retinal nerve fiber layer thickness	1 month	Retinal nerve fiber layer thickness (um) is measured by optical coherence tomography

Trial Locations

Locations (1)

Khon Kaen University; 🇹🇭 Khon Kaen, Thailand