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Recruiting NCT06848829

Difference of Tear Ferning Between Women with and Without Menopausal.

No phase Interventional Dry Eye Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pre-manepausal women.
Who it may be relevant to
Registry conditions: Dry Eye Syndromes. Basic parameters: 20 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Pre-manepausal women
    Compare tear ferning structure between pre-menopause and post-menopause women.

Primary outcome measures

  • Schirmer's test [Time frame: 5 minutes]
  • Tear film breakup time [Time frame: 20 seconds]
  • Ocular surface status [Time frame: 3 minutes]
  • Tear ferning [Time frame: 30 minutes]
  • Menopause related hormone Enzyme-linked immunosorbent assay (ELISA) [Time frame: 3 hours]
Secondary outcome measures (2)
  • Ocular surface disease index [Time frame: 20 minutes]
  • Intraocular pressure [Time frame: 2 minutes]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Taiwan · 1 center
  • Jen-Ai Hospital — Taichung

Identifiers

NCT: NCT06848829 · 202400071B0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗