Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

NCT04731207 | Unknown DMC

• 1 other identifier: HE631585
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vascular

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Retinal vascular density

  % of retinal vascular density is measured by optical coherence tomography angiography

  1 month

Secondary Outcomes (3)

• Choroidal thickness

  1 month

• Retinal nerve fiber layer thickness

  1 month

• Optic nerve head topography

  1 month

Study Arms (1)

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.

Device: Optovue®

Interventions

Optovue® DEVICE

Optical coherence tomography and optical coherece tomography angiography

Healthy pregnant women

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Khon Kaen, 40000, Thailand

RECRUITING

Study Officials

• Suthasinee Sinawat, MD

  KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suthasinee Sinawat, MD

CONTACT

+66 81 5454594; ssuthasinee@kku.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 29, 2021
• Study Start: September 3, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)