Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye
ConditionDry Eye Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tongren Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age >=18 and Age <=65.
complaint of DED 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.
Disqualifiers
History systemic autoimmune diseases and ocular/periocular malignancy.
Clinically relevant slitlamp findings or abnormal lid anatomy.
Active ocular allergies and active infection.
Pregnant or lactating women.
Trial design
Treatments tested in this trial
- Transcutaneous Auricular Vagus Nerve Stimulation
- 0.1% sodium hyaluronate eye drop
Treatment groups
256 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov