Difference of Tear Ferning Between Women with and Without Menopausal.

Not Applicable

Recruiting

• Conditions: Dry Eye Syndromes

• Registration Number: NCT06848829
• Lead Sponsor: Chung Shan Medical University

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.

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-27
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-09-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tear ferning	30 minutes	crystal structure formed from tear drops on a slide be scored.
Ocular surface status	3 minutes	To assess ocular surface health status with lissamine green stain, health or corneal abrasion.
Schirmer's test	5 minutes	To assess tear secretion volume
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.
Tear film breakup time	20 seconds	To assess tear quality

Secondary Outcome Measures

Name	Time	Method
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.
Intraocular pressure	2 minutes	To determine the effects of intervention on intraocular pressure

Trial Locations

Locations (1)

Jen-Ai Hospital; 🇨🇳 Taichung, Taiwan