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

Naval Military Medical University (Second Military Medical University)

Status: Not yet enrolling

Conditions: Iron; Dry Eye Disease

Treatments: Procedure: Diagnostic tear fluid collection and ocular surface evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT07363824

DED-A

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

52 participants in 2 patient groups

CON

Treatment:

Procedure: Diagnostic tear fluid collection and ocular surface evaluation

DED

Treatment:

Procedure: Diagnostic tear fluid collection and ocular surface evaluation