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NCT Number: NCT06848829

Difference of Tear Ferning Between Women with and Without Menopausal.

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jen-Ai Hospital

Taichung, Taiwan, 412

Location status: Recruiting

Location contact

SHU-YAN PENG, Master

CONTACT

886-933-854862

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pre-manepausal women

Other

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

Other names: Post-manepausal women

Primary outcomes

  1. Schirmer's test

    Time frame: 5 minutes

    To assess tear secretion volume

  2. Tear film breakup time

    Time frame: 20 seconds

    To assess tear quality

  3. Ocular surface status

    Time frame: 3 minutes

    To assess ocular surface health status with lissamine green stain, health or corneal abrasion.

  4. Tear ferning

    Time frame: 30 minutes

    crystal structure formed from tear drops on a slide be scored.

  5. Menopause related hormone Enzyme-linked immunosorbent assay (ELISA)

    Time frame: 3 hours

    To assess FSH/LH/E2/Progesterone/Mc5AC/Lactoferrin concentration between pre- and post-manopause women.

Secondary outcomes

  1. Ocular surface disease index

    Time frame: 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.

  2. Intraocular pressure

    Time frame: 2 minutes

    To determine the effects of intervention on intraocular pressure

Study contacts

Contact information is provided by the study sponsor or research team.

David P Lin, PhD

CONTACT

[email protected]

886-910-371286

Yiting Tian, Master

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

Difference of Tear Ferning Between Pre-and Post-menopausal Women and Between Post-menopausal Women with or Without Hormone Replacement Therapy (HRT)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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