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RecruitingNot ApplicableNCT06696625

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye

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

Sponsor

Beijing Tongren Hospital

Enrollment

256 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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

Exclusion Criteria4

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

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Interventions

DEVICETranscutaneous 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.

DRUG0.1% sodium hyaluronate eye drop

Participants received 0.1% sodium hyaluronate eye drop (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany).

Locations(1)

China Beijing TongRen Hospital, Capital Medical University Beijing, China

Beijing, Beijing Municipality, China

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NCT06696625