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

NCT07363824 — Recruiting, 52 participants, Shanghai Changzheng Hospital

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Registry	NCT07363824
Status	Recruiting
Study type	Observational
Enrollment	52 (Estimated)
Sponsor	Shanghai Changzheng Hospital (Other)
Conditions	Dry Eye Disease, Iron
Interventions	Diagnostic tear fluid collection and ocular surface evaluation (Procedure)
Dates	start 2026-02-06, primary completion 2029-05-01 (estimated), completion 2029-05-01 (estimated), first posted 2026-01-23, last updated 2026-02-10
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
CON		Procedure: Diagnostic tear fluid collection and ocular surface evaluation
DED		Procedure: Diagnostic tear fluid collection and ocular surface evaluation

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.

+Outcome measures

Primary outcomes

Correlation between tear fluid iron concentration and dry eye symptom severity [baseline]: 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.

Secondary outcomes

Correlation between tear fluid iron concentration and tear film stability [baseline]: The correlation between tear iron concentration and fluorescein tear film breakup time (FBUT) measured in seconds.
Correlation between tear fluid iron concentration and tear secretion volume [baseline]: The correlation between tear iron concentration and the result of the Schirmer I test (without anesthesia) measured in millimeters of wetting over 5 minutes.
Correlation between tear fluid iron concentration and corneal epithelial damage [baseline]: The correlation between tear iron concentration and the Corneal Fluorescein Staining (CFS) score, a standardized clinical grading of epithelial damage.

+Eligibility

Sex: All, ages: 18 Years to 70 Years, 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.

+Locations (1)

Facility	City	Country	Status
Changzheng Hospital	Shanghai	China	Recruiting