Dry Eye Syndromes
Conditions
Keywords
Dry Eye diagnosis, Tear ferning, menopause
Brief summary
Application of tear ferning test for clinical dry eye diagnosis and menopause
Detailed description
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.
Interventions
OTHERPre-manepausal women
Compare tear ferning structure between pre-menopause and post-menopause women.
Sponsors
Chung Shan Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 20 and 65 years
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear film breakup time | 20 seconds | To assess tear quality |
| Tear ferning | 30 minutes | crystal structure formed from tear drops on a slide be scored. |
| Menopause related hormone Enzyme-linked immunosorbent assay (ELISA) | 3 hours | To assess FSH/LH/E2/Progesterone/Mc5AC/Lactoferrin concentration between pre- and post-manopause women. |
| Schirmer's test | 5 minutes | To assess tear secretion volume |
| Ocular surface status | 3 minutes | To assess ocular surface health status with lissamine green stain, health or corneal abrasion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure | 2 minutes | To determine the effects of intervention on intraocular pressure |
| Ocular surface disease index | 20 minutes | A questionnaire to assess the health status on ocular surface A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease. |
Countries
Taiwan
Contacts
Primary ContactDavid P Lin, PhD
Backup ContactYiting Tian, Master
Outcome results
None listed