RecruitingNCT07363824

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

Sponsor

Shanghai Changzheng Hospital

Enrollment

52 participants

Start Date

Feb 6, 2026

Study Type

OBSERVATIONAL

Conditions

Iron Dry-Eye Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

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

Exclusion Criteria8

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.

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Interventions

PROCEDUREDiagnostic 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.