Actively Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye
Led by Beijing Tongren Hospital · Updated on 2024-11-20
256
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease. Methods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, Schirmer I, CFS, SF36, DEQ5, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.
CONDITIONS
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Dry eye disease symptoms for 6 months or longer at screening
- Ocular Surface Disease Index (OSDI) score of 25 or higher
- Tear film breakup time (TFBUT) of 5 seconds or less
- Schirmer I test without anesthesia of 5 mm or more at 5 minutes
- Corneal fluorescein staining (tCFS) score of 4 or higher
You will not qualify if you...
- History of systemic autoimmune diseases or ocular/periocular malignancy
- Clinically relevant slitlamp findings or abnormal eyelid anatomy
- Active ocular allergies or active eye infections
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China Beijing TongRen Hospital, Capital Medical University Beijing, China
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
D
Dong Wu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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