Effects of the menstrual cycle on the eye's posterior segment
Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle
This study is testing how changes in hormones during the menstrual cycle affect the eyes, specifically looking at the blood vessels and thickness in the back part of the eye.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 25 Years to 40 Years |
| Sex | Female |
| Sponsor | Khon Kaen University Academic / other |
| Locations | 1 site (Khon Kaen) |
| Trial ID | NCT04731207 on ClinicalTrials.gov |
What this trial studies
This study investigates how hormonal fluctuations during the menstrual cycle affect the posterior ocular segment, particularly focusing on retinal vascular density and choroidal thickness using advanced optical coherence tomography techniques. It aims to fill the gap in existing literature regarding the impact of the menstrual cycle on ocular physiology, as previous studies have shown mixed results. By analyzing changes in the eye's structure throughout different phases of the menstrual cycle, the study seeks to provide a clearer understanding of these physiological changes. Participants will undergo imaging with the Optovue® system to assess these variations.
Who should consider this trial
Good fit: Ideal candidates are healthy females aged 25-40 with a normal body mass index and regular menstrual cycles.
Not a fit: Patients who are pregnant, lactating, or have a history of significant ocular or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of how hormonal changes affect eye health, potentially leading to better management of ocular conditions in women.
How similar studies have performed: While there have been studies on ocular changes during the menstrual cycle, this specific focus on retinal vascular density using OCTA is novel and has not been previously published.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Khon Kaen
- Khon Kaen University — Khon Kaen, Thailand (Recruiting)
Study contacts
- Principal investigator: Suthasinee Sinawat, MD — KKU Eye Center, Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
- Study coordinator: Suthasinee Sinawat, MD
- Email: ssuthasinee@kku.ac.th
- Phone: +66 81 5454594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.