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Recruiting NCT06544447

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

Phase I / Phase II Interventional Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: taVNS, Hyaluronic acid eye drops.
Who it may be relevant to
Registry conditions: Dry Eye. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease With Meibomian Gland Dysfunction, A Randomized Clinical Trial

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 270 patients at Beijing Tongren Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, OPAS, NPSI-eye, and Schirmer I expressibility and secretion score to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

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 affe
  • 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.

Primary outcome measures

  • OSDI [Time frame: Baseline, month 1, 3, and 6]
Secondary outcome measures (4)
  • OPAS [Time frame: Baseline, month 1, 3, and 6]
  • NPSI-eye [Time frame: Baseline, month 1, 3, and 6]
  • TBUT [Time frame: Baseline, month 1, 3, and 6]
  • SchirmerI [Time frame: Baseline, month 1, 3, and 6]

Eligibility criteria

Inclusion criteria

  • Age >=18 and Age <=65.
  • Clinical diagnosis of dry eye disease with meibomian gland dysfunction.

Exclusion criteria

  • History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
  • History of Otorhinolaryngology surgery.
  • Pregnant or lactating women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • China Beijing TongRen Hospital, Capital Medical University Beijing, China — Beijing

Identifiers

NCT: NCT06544447 · taVNS-DE-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗