Evaluating Transcutaneous Auricular Vagus Nerve Stimulation With Hyaluronic Acid Eye Drops for Adults With Dry Eye Disease

What this Trial Is About

Researchers are evaluating the effect of transcutaneous auricular vagus nerve stimulation taVNS on patients with dry eye disease caused by meibomian gland dysfunction. This phase 2 randomized clinical trial aims to assess the impact of taVNS combined with hyaluronic acid eye drops on symptoms and signs of dry eye disease over several months. The study is conducted by Beijing Tongren Hospital and monitors both eye-related measures and psychological status. The study involves two groups one receiving taVNS with electrodes placed on areas rich in vagus nerve branches around the ear, and a control group receiving sham stimulation on areas with fewer vagus nerve branches. Both groups use hyaluronic acid eye drops three times daily. The taVNS device delivers electrical pulses of 1 mA current at 20 Hz frequency with brief pulses of 1 ms. Stimulation sessions and parameters are consistent between groups. Participants complete questionnaires and undergo clinical assessments at baseline, 1 month, 3 months, and 6 months, with psychological status also evaluated at 12 months. Outcome measures include Ocular Surface Disease Index OSDI scores, tear break-up time TBUT, Schirmer I test, corneal fluorescein staining tCFS, meibomian gland dysfunction scores, and psychological evaluations. The study carefully monitors response to treatment and safety over this period.

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease