What is this study trying to find out about dry eye disease?

This study is exploring if the amount of iron in tears is linked to how severe dry eye disease is. Researchers compare tear samples from people with dry eye and those with healthy eyes to see if iron levels relate to symptoms and standard eye tests. The study is sponsored by Shanghai Changzheng Hospital.

Who may be eligible for this dry eye disease clinical trial?

Adults between 18 and 70 years old with or without dry eye disease may be eligible. People must be able to provide informed consent and not have recent eye infections, surgeries, or certain medical conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this dry eye disease clinical trial?

Study-related care, including tear sample collection and eye evaluations, is provided at no cost. Personal travel or other expenses are not guaranteed to be covered and may vary.

Actively Recruiting

Age: 18Years - 70Years

All Genders

Healthy Volunteers

ID07363824

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

Led by Shanghai Changzheng Hospital · Updated on 2026-02-10

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating whether the amount of iron in tears is connected to the severity of dry eye disease. This observational study compares tear samples from people with dry eye to those from individuals with healthy eyes. The goal is to find new ways to diagnose and understand dry eye by analyzing tear iron levels alongside standard dry eye test results and symptom scores. Participants will have a single study visit involving tear fluid collection using sterile Schirmer test strips without anesthesia, placed in the lower conjunctival sac for 5 minutes. They will also undergo a detailed eye surface evaluation, including the Ocular Surface Disease Index questionnaire and clinical tests such as fluorescein tear film breakup time, corneal fluorescein staining scoring, and Schirmer I test. The tear samples will be analyzed for iron concentration. During the study visit, researchers will assess symptoms and conduct clinical tests to measure tear film stability, tear secretion volume, and corneal epithelial damage. The main measure is the correlation between tear iron levels and dry eye symptom severity. This single diagnostic visit includes no treatment, and participants usual eye care remains unchanged. The study is expected to continue until May 2029.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

History or suspicion of major systemic diseases such as blood disorders, severe infections, cancer, or chronic liver/kidney failure
Use of artificial tears or any topical eye drops within 2 hours before examination
Active eye allergy, infection, or severe eyelid inflammation within the past month
Use of antibiotics, corticosteroids, NSAIDs, or immunosuppressants systemically or topically within the past month
Contact lens use within the past month
Blood transfusion, eye surgery, or significant eye injury within the past 6 months
Women who are pregnant, breastfeeding, or postmenopausal and using hormone replacement therapy
Known allergy to fluorescein sodium dye

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