A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic tear fluid collection and ocular surface evaluation.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease, Iron. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 bre
Primary outcome measures
- Correlation between tear fluid iron concentration and dry eye symptom severity [Time frame: baseline]
Secondary outcome measures (3)
- Correlation between tear fluid iron concentration and tear film stability [Time frame: baseline]
- Correlation between tear fluid iron concentration and tear secretion volume [Time frame: baseline]
- Correlation between tear fluid iron concentration and corneal epithelial damage [Time frame: baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
China · 1 center
- Changzheng Hospital — Shanghai
Identifiers
NCT: NCT07363824 · DED-A