Difference of Tear Ferning Between Women with and Without Menopausal.

February 21, 2025 updated by: Chung Shan Medical University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David P Lin, PhD
  • Phone Number: 886-910-371286
  • Email: pcl@csmu.edu.tw

Study Contact Backup

Study Locations

  • Taiwan
      • Taichung, Taiwan, 412
        • Recruiting
        • Jen-Ai Hospital
        • Contact:
          • SHU-YAN PENG, Master
          • Phone Number: 886-933-854862

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-manepausal women
Collect clinical information, tear and blood samples from women pre-menopause with dry eye syndrome.
Other: Post-manepausal women
Collect clinical information, tear and blood samples from women post-menopause with dry eye syndrome.
Other: Pre-manepausal women
Compare tear ferning structure between pre-menopause and post-menopause women.
Other Names:
  • Post-manepausal women

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 minutes
Intraocular pressure
Time Frame: 2 minutes
To determine the effects of intervention on intraocular pressure
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202400071B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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