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NCT06364943 Clinical Trial

Tear Ferning Test for Dry Eye Diagnosis

Dry Eye Syndromes Clinical Trial

Official title:
Application of Tear Ferning Test for Clinical Dry Eye Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06364943
Other study ID # 202400020B0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 5, 2024
Est. completion date April 4, 2025

Study information
Verified date April 2024
Source Chung Shan Medical University
Contact David P Lin, PhD
Phone 886-910-371286
Email pcl@csmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Application of tear ferning test for clinical dry eye diagnosis

Description:

Comparing dry eye patients' tear ferning structure with non-dry eye patients' to develop a protocol for easy and costless diagnosis in ophthalmology.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date April 4, 2025
Est. primary completion date January 5, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Aged between 20 and 65 years - For dry eye disease group: - Schirmer's test results between 5 - 10 mm - Tear Film Break Up Time less than 10 seconds - Ocular Surface Disease Index of more than 25 Exclusion Criteria: - Those have diabetes, hypertension or other chronic diseases - No evident ocular diseases such as cornea disease, 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• with/without dry eye syndrome
compare tear ferning structure between dry eye and non-dry eye patients

Locations
Country Name City State
Taiwan Jen-Ai Hospital Taichung,

Sponsors (1)
Lead Sponsor Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Schirmer's test to assess tear secretion volume 5 minutes
Primary Tear film breakup time to assess tear quality 20 seconds
Primary Ocular surface health evaluate To assess the health status with Lissamine green stain 3 minutes
Secondary 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.		 20 minutes
Secondary Intraocular pressure to determine the effects of intervention on intraocular pressure 2 minutes
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