Tear Ferning Test for Dry Eye Diagnosis

Not Applicable

Completed

• Conditions: Dry Eye Syndromes

• Registration Number: NCT06364943
• Lead Sponsor: Chung Shan Medical University

Brief Summary

Application of tear ferning test for clinical dry eye diagnosis

Detailed Description

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

Study Timeline

• Study Start: 2024-04-05
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-12
• Study First Posted: 2024-04-15
• Primary Completion: 2024-05-22
• Study Completion: 2024-05-22
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-24
• Last Update Posted: 2025-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ocular surface health evaluate	3 minutes	To assess the health status with Lissamine green stain
Tear film breakup time	20 seconds	to assess tear quality
Schirmer's test	5 minutes	to assess tear secretion volume

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure	2 minutes	to determine the effects of intervention on intraocular pressure
Ocular surface disease index	20 minutes	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.

Trial Locations

Locations (1)

Jen-Ai Hospital; 🇨🇳 Taichung, Taiwan