Difference of Tear Ferning Between Women with and Without Menopausal.

NCT ID: NCT06848829

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-01

Brief Summary

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Application of tear ferning test for clinical dry eye diagnosis and menopause

Detailed Description

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pre-manepausal women

Collect clinical information, tear and blood samples from women pre-menopause with dry eye syndrome.

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-manepausal women

Collect clinical information, tear and blood samples from women post-menopause with dry eye syndrome.

Group Type OTHER

Pre-manepausal women

Intervention Type OTHER

Compare tear ferning structure between pre-menopause and post-menopause women.

Interventions

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Pre-manepausal women

Compare tear ferning structure between pre-menopause and post-menopause women.

Intervention Type OTHER

Other Intervention Names

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Post-manepausal women

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jen-Ai Hospital

Taichung, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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David P Lin, PhD

Role: CONTACT

886-910-371286

Yiting Tian, Master

Role: CONTACT

Facility Contacts

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SHU-YAN PENG, Master

Role: primary

886-933-854862

Other Identifiers

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202400071B0

Identifier Type: -

Identifier Source: org_study_id

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