Physiologic Changes of Posterior Ocular Segment During the Menstrual Cycle
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Retinal vascular density
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female with age 25-40 yr
- •Normal body mass index (18.5-24.9)
- •Regular menstrual cycle (28-32 days)
- •Written informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Optovue® (Device)
结局指标
主要结局
Retinal vascular density
时间窗: 1 month
% of retinal vascular density is measured by optical coherence tomography angiography
次要结局
- Optic nerve head topography(1 month)
- Choroidal thickness(1 month)
- Retinal nerve fiber layer thickness(1 month)
研究者
Suthasinee Sinawat
Associate Professor
Khon Kaen University