Severe dry eye disease
Conditions
Interventions
Cyclosporine group:Sodium hyaluronate eye drops qid + Cyclosporine eye drops bid
Experimental group:Sodium hyaluronate eye drops qid + exosome nebulization therapy bid
Sponsors
Wenzhou Medical University Affiliated Eye and Vision Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 60 years old (inclusive of the boundaries), gender not restricted. 2. Meet the diagnostic criteria for severe dry eye (Chinese Clinical Diagnosis and Treatment Expert Consensus (2024)), slit lamp microscopy examination, corneal damage area of 2 quadrants or more, and/or corneal fluorescein staining point count >= 30, TBUT < 2 seconds. Corneal fluorescein staining points fuse into coarse dots, patches, or are accompanied by filamentous substances. 3. Voluntary participants and those who have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those who planned to undergo ocular surgery within 6 months before the screening period or during the study. 2. Pregnant women or lactating women. 3. Individuals with existing fungal, viral, bacterial keratitis or other active inflammatory conditions of the ocular surface. 4. Those wearing contact lenses. 5. Those who had a history of active ocular surface inflammation within 30 days before the screening. 6. Other conditions deemed unsuitable for participation in the trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal Staining Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| OSDI-6;Tear inflammatory factors.;Meibomian Gland Score;Visual acuity;Tear film break-up time;Tear river height;Conjunctival Hyperemia Score;Tear secretion test; | — |
Countries
China
Contacts
Public ContactJinyang Li
Wenzhou Medical University Affiliated Eye and Vision Hospital
Outcome results
None listed