Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye: a Randomized Clinical 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.

Inclusion Criteria:

1. Age >=18 and Age <=65.
2. complaint of DED symptoms for 6 months or longer at screening.
3. ocular surface disease index (OSDI) score of 25 or higher.
4. tear film breakup time (TFBUT) of 5 seconds or less.
5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes.
6. tCFS score of 4 or higher.

Exclusion Criteria:

1. History systemic autoimmune diseases and ocular/periocular malignancy.
2. Clinically relevant slitlamp findings or abnormal lid anatomy.
3. Active ocular allergies and active infection.
4. Pregnant or lactating women.