Actively Recruiting
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
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants attend a single study visit where tear fluid is collected and a comprehensive ocular surface evaluation is performed, including symptom assessment and clinical tests.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Changzheng Hospital
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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