Difference of Tear Ferning Between Women with and Without Menopausal.
ConditionDry Eye Syndromes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-65
SponsorChung Shan Medical University
About this trial
Application of tear ferning test for clinical dry eye diagnosis and menopause
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 20 and 65 years
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Pre-manepausal women
Other interventionCompare tear ferning structure between pre-menopause and post-menopause women.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Pre-manepausal womenNo intervention 0 interventions
Group B: Post-manepausal womenOther 1 intervention
Trial outcomes
Primary outcomes
1
Schirmer's test
To assess tear secretion volume
Time frame
5 minutes2
Tear film breakup time
To assess tear quality
Time frame
20 seconds3
Ocular surface status
To assess ocular surface health status with lissamine green stain, health or corneal abrasion.
Time frame
3 minutes4
Tear ferning
crystal structure formed from tear drops on a slide be scored.
Time frame
30 minutesSecondary outcomes
1
Ocular surface disease index
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.
Time frame
20 minutes2
Intraocular pressure
To determine the effects of intervention on intraocular pressure
Time frame
2 minutesSponsors and contacts
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Source ClinicalTrials.gov