Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease With Meibomian Gland Dysfunction

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

October 1, 2024

Study Completion Date

October 1, 2024

Conditions
Dry Eye
Interventions
DEVICE

taVNS

"taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water.~The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Patients in control group were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution."

DRUG

Hyaluronic acid eye drops

Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.

Trial Locations (1)

100730

RECRUITING

China Beijing TongRen Hospital, Capital Medical University Beijing, China, Beijing

All Listed Sponsors
lead

Beijing Tongren Hospital

OTHER