Dry Eye Disease
Conditions
Interventions
iTEAR Treatment Group:iTEAR Muqin® Therapy Device Treatment
Press Needle Treatment Group:Press Needle Embedding Therapy
iTEAR + Press Needle Group:iTEAR Muqin® Therapy Device Combined with Press Needle Embedding Therapy
Sponsors
Shanghai Fengxian District Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the diagnostic criteria for mild to moderate dry eye disease according to the 2024 Chinese Expert Consensus on Clinical Diagnosis and Management of Dry Eye, with corneal damage involving no more than 2 quadrants, corneal fluorescein staining points < 30, tear film breakup time (TBUT) = 10 seconds, and Schirmer I test result (without topical anesthesia) = 10 mm/5 minutes. 2.Aged 18 to 60 years. 3.Voluntary participation in this study and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have received systemic corticosteroid or immunosuppressive therapy within the past 3 months; 2. Pregnant or lactating patients; menopausal patients undergoing hormone therapy; 3. Patients with severe primary diseases affecting the cardiovascular, cerebrovascular, hepatic, renal, or hematological systems, or those with mental or psychological disorders who are on long-term medication for such conditions, or patients with cognitive impairment; 4. Patients who have undergone ocular surgery within the last 3 months; 5. Patients with ocular complications such as inflammation, infection, or trauma; 6. Patients who have used topical treatments other than artificial tears within the past 3 months, including topical cyclosporine or steroid eye drops.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schirmer I Test (without topical anesthesia); | — |
Secondary
| Measure | Time frame |
|---|---|
| tear film breakup time;Standardized Symptom Score Scale; | — |
Countries
China
Contacts
Public ContactXinlu Zheng
Shanghai Fengxian District Central Hospital
Outcome results
None listed