A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorShanghai Changzheng Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 18 and 70 years, inclusive.
Willing and able to provide written informed consent.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Diagnostic tear fluid collection and ocular surface evaluation
Procedure/SurgeryThis 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.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: CON1 intervention
Group B: DED1 intervention
Trial outcomes
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.
Time frame
baselineSecondary outcomes
1
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
baseline2
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
baseline3
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
baselineSponsors and contacts
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Source ClinicalTrials.gov