NCT07363824

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 52 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

• Dry Eye Disease
• Iron

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-06
• Primary completion: 2029-05-01
• Completion: 2029-05-01
• First posted: 2026-01-23
• Last updated: 2026-02-10

Locations

1 site across 1 country: China