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Research on multi-dimensional biomarkers of tears in Dry Eye, Healthy Population and other Ocular surface diseases

Research on multi-dimensional biomarkers of tears in Dry Eye, Healthy Population and other Ocular surface diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122808
Enrollment
Unknown
Registered
2026-04-17
Start date
2026-04-19
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye disease(DED)

Interventions

Non-dry eye disease control group:None
Healthy Control Group:None

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18-70 years old, gender not limited, able to understand and sign informed consent forms; 2.Dry Eye group (DED) : according to TFOS Dews III (2025) diagnostic criteria: (symptom positivity: Osdi-6 score =4 points (or OSDI =13 points) ; and with at least one of the following signs of loss of homeostasis: non-invasive tear film rupture time (NIBUT) 8 mOsm/L) or positive ocular surface staining (corneal fluorescein staining > 5 points or conjunctival risperidone green staining > 9 points or palpebral margin staining length =2 mm and width =25%) ; 3.Healthy control group (Control): no eye discomfort symptoms (OSDI-6 <4 points or OSDI <13 points); normal eye surface steady-state indicators (NIBUT = 10 seconds, no eye surface staining, normal tear osmotic pressure); no eye disease history and surgical history; 4.Non-dry eye ocular surface disease control group (Other): Non-dry eye ocular surface disease clinically diagnosed by slit lamp microscopy. For patients with "co-disease" who may also have dry eye signs (e.g. NIBUT < 10s), clinical judgment of the investigator must be made at the time of enrollment to confirm that the main driving factor of their ocular complaints and signs is the above "other ocular surface disease".

Exclusion criteria

Exclusion criteria: 1.High-risk infectious eye disease: in the acute phase of bacterial, viral (such as adenovirus conjunctivitis) , fungal keratitis or conjunctivitis patients; 2.Severe ocular surface damage: corneal fluorescein staining (CFS) score> 3, or presence of corneal ulcers, perforations and other lesions that may seriously interfere with tear components; 3.History of eye surgery (e.g. cataract, refractive surgery) or eye trauma in recent 3 months; 4.Have worn contact lenses (contact lenses) within the last 1 month; 5.Within the past month, the following drugs have been used in the eyes and throughout the body: antibiotics, glucocorticoid drugs, immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, eye soaps and acaricides. 6.Artificial tears were used on the day of the examination; 7.Have a systemic disorder that severely affects tear production (such as uncontrolled diabetes, Sjögren's syndrome) ; 8.Pregnant or lactating women; 9.Insufficient tear samples (< 10 ?L) for follow-up testing; 10.The investigator considers that the sample does not meet the test requirements and the investigator considers that it is not suitable to participate in the investigator;

Design outcomes

Primary

MeasureTime frame
Tear Metabolites;Tear Functional Proteins;Tear Inflammatory Factors;

Secondary

MeasureTime frame
OSDI Score;CFS Grade;NIBUT;Schirmer I Test Value;

Countries

China

Contacts

Public ContactQi Dai

Eye Hospital, Wenzhou Medical University

dq@mail.eye.ac.cn+86 571 88185666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026