A Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for Treating Dry Eye Disease in Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the effects of transcutaneous auricular vagus nerve stimulation taVNS in patients with dry eye disease. This study enrolled 256 patients who experienced dry eye symptoms for six months or more and assessed various measures including symptoms, tear film stability, ocular surface health, and psychological status over six months. The research aims to understand if taVNS can improve these aspects in dry eye disease. Participants receive stimulation using a taVNS device that delivers electrical current through electrodes placed on specific parts of the ear. The device applies a 1 mA current at 20 Hz with 1 ms square-wave pulses. One group receives stimulation targeting the ear regions rich in vagus nerve branches, while a control group receives sham stimulation at areas with fewer vagus nerve branches. All patients also use 0.1% sodium hyaluronate eye drops. Throughout the study, participants complete questionnaires and undergo tests at baseline, 1 month, 3 months, and 6 months to evaluate dry eye symptoms and eye health. Measures include the Ocular Surface Disease Index OSDI, tear film breakup time, Schirmer test, corneal fluorescein staining, dry eye questionnaire, psychological assessment, and quality of life survey. Data collection continues up to 12 months for some assessments to monitor long-term effects and safety.

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye