Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

Sponsor

Khon Kaen University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04731207

Collaborator

(none)

Enrollment

Location

Arm

15.9

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vascular	Device: Optovue®	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle

Anticipated Study Start Date :

Sep 3, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Retinal vascular density [1 month]
% of retinal vascular density is measured by optical coherence tomography angiography

Secondary Outcome Measures

Choroidal thickness [1 month]
Choroidal thickness (um) is measured by optical coherence tomography
Retinal nerve fiber layer thickness [1 month]
Retinal nerve fiber layer 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Khon Kaen University	Khon Kaen		Thailand	40000

Sponsors and Collaborators

Khon Kaen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suthasinee Sinawat, Associate Professor, Khon Kaen University

ClinicalTrials.gov Identifier:

NCT04731207

Other Study ID Numbers:

HE631585

First Posted:

Jan 29, 2021

Last Update Posted:

Sep 5, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Suthasinee Sinawat, Associate Professor, Khon Kaen University

retinal vascular density

choroidal thickness

optic nerve head

optical coherence tomography

optical coherence tomography angiography

menstrual cycle

Study Results

No Results Posted as of Sep 5, 2021