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
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

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