Actively Recruiting

Phase Not Applicable
Age: 20Years - 65Years
FEMALE
Healthy Volunteers
ID06848829

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

Led by Chung Shan Medical University · Updated on 2025-02-27

90

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the differences in tear ferning patterns between women before and after menopause, including those using hormone replacement therapy (HRT). The study focuses on women with dry eye syndrome to better understand how menopause and HRT may affect tear structure and related eye health. The trial is interventional and sponsored by Chung Shan Medical University. Participants are divided into two groups: pre-menopausal women with dry eye syndrome and post-menopausal women with dry eye syndrome. The study collects clinical information along with tear and blood samples. Measurements include tear volume, tear osmolarity, intraocular pressure, and tear break-up time. Hormone levels related to menopause are assessed using an enzyme-linked immunosorbent assay (ELISA). During the study, participants undergo several tests, including Schirmer's test, tear film breakup time, ocular surface evaluation, and tear ferning analysis. Blood samples are collected for hormone analysis. The study also measures intraocular pressure and uses questionnaires to assess ocular surface disease symptoms. Participation involves multiple assessments lasting from minutes to hours, with no masking or randomization involved.

CONDITIONS

Brief Title

Difference of Tear Ferning Between Women with and Without Menopausal.

Who Can Participate

Age: 20Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 20 and 65 years
Not Eligible

You will not qualify if you...

  • No evident ocular diseases such as cornea, cataracts, vitreous degeneration, glaucoma, and retinopathy
  • Belong to vulnerable groups (pregnant women, prisoners, ethical minorities, economically or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminally ill individuals)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day assessment

Participants undergo measurements including tear ferning structure, tear volume, tear osmolarity, intraocular pressure, tear break-up time, and blood sampling for hormone analysis.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are observed for differences in tear ferning and ocular surface status related to menopausal status and hormone replacement therapy.

Follow-up visits may occur as part of monitoring

Trial Site Locations

Total: 1 location

1

Jen-Ai Hospital

Taichung, Taiwan, Taiwan, 412

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Research Team

D

David P Lin, PhD

Y

Yiting Tian, Master

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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