Refractive Surgery-Related Dry Eye
Conditions
Interventions
Stimulation Group:Stimulate the extranasal nerve using tear stimulation device iTEAR
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Individuals who voluntarily participate and sign the informed consent form, willing to comply with the treatment schedule specified in the trial protocol, and willing to attend follow-up visits on time. 2. Aged 18 years or older, any gender. 3. Have a history of refractive surgery prior to the screening visit (V0 visit). 4. Have a history of bilateral dry eye disease prior to the screening visit (V0 visit) (with at least one subjective symptom such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, or fluctuating vision). 5. Meet the diagnostic criteria for dry eye according to the Chinese expert consensus on dry eye at the screening visit (V0 visit). 6. Have discontinued the use of artificial tears at least 72 hours prior to the screening period and are willing to stop using artificial tears during the trial..
Exclusion criteria
Exclusion criteria: 1. Currently have an active eye infection or inflammation; 2. Currently have lacrimal gland dysfunction, such as congenital absence of lacrimal glands, lacrimal duct obstruction, or dacryocystitis, or other conditions affecting ocular surface stability; 3. History of wearing corneal contact lenses or eye surgery within the past three months; 4. Currently have uncontrolled severe systemic diseases; 5. Use of medications affecting tear secretion within 72 hours; 6. Participation in other clinical studies within the past 30 days; 7. Allergic to diagnostic dyes; 8. Deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal Fluorescein Staining (CFS) Score;Tear breaking up time; | — |
Secondary
| Measure | Time frame |
|---|---|
| OSDI Score;Tear secretion;Percentage of Blinks;Tear Meniscus Height;Lipid Layer Thickness; | — |
Countries
China
Contacts
Public ContactShaozhen Zhao
Tianjin Medical University Eye Hospital
Outcome results
None listed