RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged between 18 and 70 years, inclusive. - Willing and able to provide written willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Changzheng Hospital

Shanghai, China