Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

NCT ID: NCT04731207

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2023-12-30

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.

Conditions

Retinal Vascular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Optovue®

Intervention Type: DEVICE

Optical coherence tomography and optical coherece tomography angiography

Interventions

Optovue®

Optical coherence tomography and optical coherece tomography angiography

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Suthasinee Sinawat

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suthasinee Sinawat, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Khon Kaen University

Khon Kaen, , Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Suthasinee Sinawat, MD

Role: CONTACT

ssuthasinee@kku.ac.th

+66 81 5454594

Facility Contacts

Suthasinee Sinawat, MD

Role: primary

ssuthasinee@kku.ac.th

0815454594

Other Identifiers

HE631585

Identifier Type: -

Identifier Source: org_study_id