Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease: A Randomized Clinical Trial
Beijing Tongren Hospital
128 participants
Jul 1, 2021
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria2
- Age >=18 and Age <=75.
- Clinical diagnosis of dry eye disease.
Exclusion Criteria3
- History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
- History of phthalmology surgery.
- Pregnant or lactating women.
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT04673643