Difference of Tear Ferning Between Pre-and Post-menopausal Women and Between Post-menopausal Women with or Without Hormone Replacement Therapy (HRT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Schirmer's test
研究概览
简要总结
Application of tear ferning test for clinical dry eye diagnosis and menopause
详细描述
Analyzing the difference in tear ferning structure between women pre and post-menopause with and without hormone replacement therapy (HRT). Tear and blood samples were collected for a menopause-related Enzyme-linked immunosorbent assay. Tear volume, tear osmolarity, intraocular pressure, and tear break-up time were also measured for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 20 and 65 years
排除标准
- •No evident ocular diseases such as cornea, cataracts, vitreous degeneration, glaucoma, and retinopathy.
- •Belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
研究组 & 干预措施
Pre-manepausal women
Collect clinical information, tear and blood samples from women pre-menopause with dry eye syndrome.
Post-manepausal women
Collect clinical information, tear and blood samples from women post-menopause with dry eye syndrome.
干预措施: Pre-manepausal women (Other)
结局指标
主要结局
Schirmer's test
时间窗: 5 minutes
To assess tear secretion volume
Ocular surface status
时间窗: 3 minutes
To assess ocular surface health status with lissamine green stain, health or corneal abrasion.
Tear ferning
时间窗: 30 minutes
crystal structure formed from tear drops on a slide be scored.
Menopause related hormone Enzyme-linked immunosorbent assay (ELISA)
时间窗: 3 hours
To assess FSH/LH/E2/Progesterone/Mc5AC/Lactoferrin concentration between pre- and post-manopause women.
Tear film breakup time
时间窗: 20 seconds
To assess tear quality
次要结局
- Ocular surface disease index(20 minutes)
- Intraocular pressure(2 minutes)