Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

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.

Study Overview

• Status: Recruiting
• Conditions: Retinal Vascular
• Intervention / Treatment: Device: Optovue®

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 Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suthasinee Sinawat, MD; Phone Number: +66 81 5454594; Email: ssuthasinee@kku.ac.th

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40000
    • Recruiting
    • Khon Kaen University
    • Contact: Suthasinee Sinawat, MD; Phone Number: 0815454594; Email: ssuthasinee@kku.ac.th
    • Principal Investigator: Suthasinee Sinawat, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Healthy pregnant women; 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®; Optical coherence tomography and optical coherece tomography angiography

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Principal Investigator: Suthasinee Sinawat, MD, KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2021
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: menstrual cycle; optical coherence tomography; optical coherence tomography angiography; choroidal thickness; retinal vascular density; optic nerve head
• Other Study ID Numbers: HE631585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No