A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

February 6, 2026 updated by: Ruili Wei, Shanghai Changzheng Hospital
This study aims to see if the amount of iron in tears is linked to how severe dry eye disease is. We hope this can lead to a new way to help diagnose and understand dry eye. This is an observational study. We will compare tear samples from people with dry eye to samples from people with healthy eyes. We will measure the iron content in the tears and see if it correlates with standard dry eye test results and symptom scores.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

52

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

  • China
      • Shanghai, China
        • Recruiting
        • Changzheng hospital
        • Contact:

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

Sampling Method

Non-Probability Sample

Study Population

Based on your study protocol, here is the description for the "Study Population Description" field:

This single-center, cross-sectional study will recruit participants from the patient population and staff/community at the Ophthalmology Department of Shanghai Changzheng Hospital. The Dry Eye Disease (DED) group will consist of consecutive patients presenting to the clinic who are diagnosed with DED according to the 2024 Chinese Expert Consensus criteria. The healthy control group will be recruited through hospital staff volunteers and community advertisements. All participants will be enrolled during the specified study period from the single site.

Description

Inclusion Criteria:

  • Aged between 18 and 70 years, inclusive.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • History or clinical suspicion of significant systemic conditions: hematologic diseases, severe systemic infections, malignancies (treated or untreated), or chronic hepatic/renal insufficiency.
  • Use of artificial tears or any topical eye drops within 2 hours prior to examination.
  • Active ocular allergy, infection, or severe blepharitis within the past 1 month.
  • Systemic or topical use of antibiotics, corticosteroids, NSAIDs, or immunosuppressants within the past 1 month.
  • History of contact lens wear within the past 1 month.
  • History of blood transfusion, ocular surgery, or significant ocular trauma within the past 6 months.
  • Women who are pregnant, breastfeeding, or postmenopausal women undergoing hormone replacement therapy.
  • Known hypersensitivity to fluorescein sodium.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CON
Procedure: Diagnostic tear fluid collection and ocular surface evaluation

This is an observational study; no therapeutic intervention is administered. All participants undergo a single, standardized study visit that includes:

Tear Fluid Collection: Tear samples are collected using sterile Schirmer test strips (without anesthesia) placed in the lower conjunctival sac for 5 minutes.

Comprehensive Ocular Surface Evaluation:

Symptom Assessment: Completion of the Ocular Surface Disease Index (OSDI) questionnaire.

Clinical Tests: Measurement of fluorescein tear film breakup time (FBUT), corneal fluorescein staining (CFS) scoring, and Schirmer I test.

The collected tear samples are subsequently analyzed for iron concentration. All procedures are diagnostic and evaluative in nature.
DED
Procedure: Diagnostic tear fluid collection and ocular surface evaluation

This is an observational study; no therapeutic intervention is administered. All participants undergo a single, standardized study visit that includes:

Tear Fluid Collection: Tear samples are collected using sterile Schirmer test strips (without anesthesia) placed in the lower conjunctival sac for 5 minutes.

Comprehensive Ocular Surface Evaluation:

Symptom Assessment: Completion of the Ocular Surface Disease Index (OSDI) questionnaire.

Clinical Tests: Measurement of fluorescein tear film breakup time (FBUT), corneal fluorescein staining (CFS) scoring, and Schirmer I test.

The collected tear samples are subsequently analyzed for iron concentration. All procedures are diagnostic and evaluative in nature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between tear fluid iron concentration and dry eye symptom severity
Time Frame: baseline
The strength of association between the concentration of iron (in μg/mL) in tear fluid collected via Schirmer strips and the total score on the Ocular Surface Disease Index (OSDI) questionnaire.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between tear fluid iron concentration and tear film stability
Time Frame: baseline
The correlation between tear iron concentration and fluorescein tear film breakup time (FBUT) measured in seconds.
baseline
Correlation between tear fluid iron concentration and tear secretion volume
Time Frame: baseline
The correlation between tear iron concentration and the result of the Schirmer I test (without anesthesia) measured in millimeters of wetting over 5 minutes.
baseline
Correlation between tear fluid iron concentration and corneal epithelial damage
Time Frame: baseline
The correlation between tear iron concentration and the Corneal Fluorescein Staining (CFS) score, a standardized clinical grading of epithelial damage.
baseline

Collaborators and Investigators

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

Sponsor

Shanghai Changzheng Hospital

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)

February 6, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DED-A

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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