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RECRUITINGPhase 2INTERVENTIONAL

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease: A Randomized Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age \>=18 and Age \<=75. 2. Clinical diagnosis of dry eye disease. Who Should NOT Join This Trial: 1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. History of phthalmology surgery. 3. Pregnant or lactating women. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation

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.

Locations (2)

Beijing Tongren Hospital
Beijing, China
Wu Dong
Beijing, China