Difference of Tear Ferning Between Women with and Without Menopausal.
1 other identifier
interventional
90
1 country
1
Brief Summary
Application of tear ferning test for clinical dry eye diagnosis and menopause
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 14, 2025
CompletedFirst Posted
Study publicly available on registry
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedFebruary 27, 2025
February 1, 2025
11 months
February 14, 2025
February 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Schirmer's test
To assess tear secretion volume
5 minutes
Tear film breakup time
To assess tear quality
20 seconds
Ocular surface status
To assess ocular surface health status with lissamine green stain, health or corneal abrasion.
3 minutes
Tear ferning
crystal structure formed from tear drops on a slide be scored.
30 minutes
Menopause related hormone Enzyme-linked immunosorbent assay (ELISA)
To assess FSH/LH/E2/Progesterone/Mc5AC/Lactoferrin concentration between pre- and post-manopause women.
3 hours
Secondary Outcomes (2)
Ocular surface disease index
20 minutes
Intraocular pressure
2 minutes
Study Arms (2)
Pre-manepausal women
NO INTERVENTIONCollect clinical information, tear and blood samples from women pre-menopause with dry eye syndrome.
Post-manepausal women
OTHERCollect clinical information, tear and blood samples from women post-menopause with dry eye syndrome.
Interventions
Compare tear ferning structure between pre-menopause and post-menopause women.
Eligibility Criteria
You may qualify if:
- Aged between 20 and 65 years
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jen-Ai Hospital
Taichung, Taiwan, 412, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2025
First Posted
February 27, 2025
Study Start
October 1, 2024
Primary Completion
September 1, 2025
Study Completion
October 1, 2025
Last Updated
February 27, 2025
Record last verified: 2025-02