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Recruiting NCT07363824

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

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Trial Parameters

Condition Dry Eye Disease
Sponsor Shanghai Changzheng Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 52
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2026-02-06
Completion 2029-05
Interventions
Diagnostic tear fluid collection and ocular surface evaluation

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Brief 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 Criteria

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.

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