Tear Ferning Test for Dry Eye Diagnosis

August 24, 2025 updated by: David Pei-Cheng Lin, Chung Shan Medical University

Application of Tear Ferning Test for Clinical Dry Eye Diagnosis

Application of tear ferning test for clinical dry eye diagnosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 412
        • Jen-Ai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Dry eye patients
Collect clinical information and tear samples from patients with dry eye syndrome.
Other: Non-Dry eye patients
Collect clinical information and tear samples from patients without dry eye syndrome.
Other: with/without dry eye syndrome
compare tear ferning structure between dry eye and non-dry eye patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular surface disease index
Time Frame: 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.
20 minutes
Intraocular pressure
Time Frame: 2 minutes
to determine the effects of intervention on intraocular pressure
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2024

Primary Completion (Actual)

May 22, 2024

Study Completion (Actual)

May 22, 2024

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 15, 2024

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 24, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202400020B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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