An observational study in Dry Eye Disease and Iron, sponsored by Shanghai Changzheng Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Shanghai Changzheng Hospital · Observational
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 52 is below the median of 90 across 171 observational studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Shanghai Changzheng Hospital is the lead sponsor of 125 studies on the registry; 60 are open to participants now.
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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.
Exclusion Criteria:
Procedure: Diagnostic tear fluid collection and ocular surface evaluation
Procedure: Diagnostic tear fluid collection and ocular surface evaluation
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.
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.
Time frame: baseline
Correlation between tear fluid iron concentration and tear film stability
The correlation between tear iron concentration and fluorescein tear film breakup time (FBUT) measured in seconds.
Time frame: baseline
Correlation between tear fluid iron concentration and tear secretion volume
The correlation between tear iron concentration and the result of the Schirmer I test (without anesthesia) measured in millimeters of wetting over 5 minutes.
Time frame: baseline
Correlation between tear fluid iron concentration and corneal epithelial damage
The correlation between tear iron concentration and the Corneal Fluorescein Staining (CFS) score, a standardized clinical grading of epithelial damage.
Time frame: baseline
Plan to share: No
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Shanghai Changzheng Hospital