Tear iron levels and dry eye severity
A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.
This project will see if the amount of iron in tears is linked to how severe someone's dry eye is by comparing people with dry eye to healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Changzheng Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07363824 on ClinicalTrials.gov |
What this trial studies
This is an observational comparison of tear samples and ocular surface tests between adults with dry eye and healthy controls. Participants will undergo tear fluid collection and standard ocular surface evaluations, and tear iron content will be measured in the laboratory. Researchers will correlate tear iron levels with clinical dry eye test results and symptom scores to look for meaningful relationships. Eligible participants are adults aged 18–70 without major systemic disease or recent ocular interventions or topical/systemic medication use that could affect results.
Who should consider this trial
Good fit: Adults aged 18–70 with dry eye or healthy volunteers who can give written informed consent and meet the study's exclusion criteria are ideal candidates.
Not a fit: People with significant systemic illness, recent ocular surgery or trauma, recent contact lens wear, active ocular infection or allergy, recent topical/systemic anti-inflammatory or antibiotic use, pregnant or breastfeeding women, or those outside the 18–70 age range are unlikely to benefit.
Why it matters
Potential benefit: If successful, measuring iron in tears could become a simple biomarker to help diagnose or gauge the severity of dry eye.
How similar studies have performed: This approach is relatively novel for tear iron specifically, with limited prior data, although other tear biomarkers have been studied in dry eye.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Changzheng Hospital — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.