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Effectiveness evaluation of Matrix Metalloproteinase 9 detection kit (colloidal gold method)

Effectiveness evaluation of Matrix Metalloproteinase 9 detection kit (colloidal gold method) in the diagnosis of dry eye disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070715
Enrollment
Unknown
Registered
2023-04-20
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Dry eye disease

Interventions

Gold Standard:Patients who met the following two criteria a) Patients with complaint of dryness, foreign body sensation, burning, eyestrain, redness and impaired vision, OSDI=13, FBUT=5s or Schrimer I
Index test:Matrix Metalloproteinase 9 detection kit (colloidal gold method)

Sponsors

Xiangyang No.1 People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Subject gender, age were not limited, and clinical background information was complete (including patient ID number, medical record number, gender, age, disease history, clinical diagnosis background information, etc.); (2) Voluntarily participated in the study and signed an informed consent form, or signed an informed consent form by a legally authorized representative; (3) Patients, suspected population in the onset phase of dry eye disease; (4) The patient complained of ocular dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness of the eye, fluctuation of vision and other subjective symptoms. Note: articles (1) and (2) must be satisfied and then any one of (3) to (4) can be enrolled.

Exclusion criteria

Exclusion criteria: (1) Unable to cooperate with the investigator for severe mental disorder or language disorder sampled subjects; (2) Patients who have been enrolled in this clinical trial; (3) Subjects voluntarily dropped out or could not complete for various reasons; (4) The clinical diagnoses were active allergic conjunctivitis, having undergone inner and outer eye surgery in January, having suffered from trauma to the eye in January, having a history of contact lens wearing in January, pregnancy status, or the presence of any ocular infectious disease. (5) Patients for whom the investigator considered it inappropriate to participate in this clinical trial for various other reasons.

Design outcomes

Primary

MeasureTime frame
MMP-9 in the human ocular surface rinsing fluid ;

Secondary

MeasureTime frame
Sensitivity;Specificity;Positive predictive value;Negative predictive value;Total consistent rate;

Countries

China

Contacts

Public ContactYang Jinbo

Xiangyang No.1 People's Hospital

yangwhu2000@sina.com+86 13487179541

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026