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

NCT07363824 | Recruiting

• 1 other identifier: DED-A
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease; Iron

Keywords

DED; iron

Outcome Measures

Primary Outcomes (1)

• Correlation between tear fluid iron concentration and dry eye symptom severity

  The strength of association between the concentration of iron (in μg/mL) in tear fluid collected via Schirmer strips and the total score on the Ocular Surface Disease Index (OSDI) questionnaire.

  baseline

Secondary Outcomes (3)

• Correlation between tear fluid iron concentration and tear film stability

  baseline

• Correlation between tear fluid iron concentration and tear secretion volume

  baseline

• Correlation between tear fluid iron concentration and corneal epithelial damage

  baseline

Study Arms (2)

CON

Procedure: Diagnostic tear fluid collection and ocular surface evaluation

DED

Procedure: Diagnostic tear fluid collection and ocular surface evaluation

Interventions

Diagnostic tear fluid collection and ocular surface evaluation PROCEDURE

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.

CON; DED

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Based on your study protocol, here is the description for the "Study Population Description" field: This single-center, cross-sectional study will recruit participants from the patient population and staff/community at the Ophthalmology Department of Shanghai Changzheng Hospital. The Dry Eye Disease (DED) group will consist of consecutive patients presenting to the clinic who are diagnosed with DED according to the 2024 Chinese Expert Consensus criteria. The healthy control group will be recruited through hospital staff volunteers and community advertisements. All participants will be enrolled during the specified study period from the single site.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Changzheng Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Ophthalmology

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 23, 2026
• Study Start: February 6, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)