Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease

Phase 2RecruitingNCT04673643

Beijing Tongren Hospital128 enrolled

Overview

Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease with meibomian gland dysfunction. Methods: We enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.OSDI score, TBUT, Schirmer I, tCFS, MGD score, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

128

Conditions

Dry Eye Disease

Interventions

Transcutaneous Auricular Vagus Nerve StimulationDEVICE

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.

Hyaluronic acid eye dropsDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>=18 and Age \<=75. 2. Clinical diagnosis of dry eye disease. Exclusion Criteria: 1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. History of phthalmology surgery. 3. Pregnant or lactating women.

Locations (2)

Beijing Tongren Hospital

Beijing, China

RECRUITING

Wu Dong

Beijing, China

COMPLETED

Outcomes

Primary Outcomes

OSDI

Ocular Surface Disease Index (OSDI) questionnaire: The OSDI questionnaire is designed to assess the severity of symptoms and the impact of ocular surface diseases, such as dry eye disease, on a patient's quality of life.