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

NCT07363824 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2026-02-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Shanghai Changzheng Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2029-05-31
Completion
2029-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363824 on ClinicalTrials.gov