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NCT Number: NCT06544447

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

China Beijing TongRen Hospital, Capital Medical University Beijing, China

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Dong Wu, Doctor

CONTACT

[email protected]

8613810988682

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

taVNS

Device

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 drops

Drug

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 outcomes

  1. OSDI

    Time frame: Baseline, month 1, 3, and 6

    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.

Secondary outcomes

  1. OPAS

    Time frame: Baseline, month 1, 3, and 6

    Ocular Surface Disease Index-Personalized Assessment Score (OPAS): The OPAS is a tailored version of the traditional Ocular Surface Disease Index (OSDI). It is designed to offer a more personalized assessment of ocular surface diseases by adapting the standard questionnaire to reflect individual patient experiences and symptoms more accurately. The personalized nature of OPAS aims to offer a more precise measure of how the disease impacts the patient's quality of life and daily functioning.

  2. NPSI-eye

    Time frame: Baseline, month 1, 3, and 6

    Neuropathic Pain Symptom Inventory - Eye (NPSI-eye): The NPSI-eye is a specialized tool designed to assess neuropathic pain symptoms specifically in the context of eye conditions. It helps in identifying and quantifying symptoms associated with neuropathic pain in the ocular region. Higher scores indicate more severe or frequent neuropathic pain symptoms.

  3. TBUT

    Time frame: Baseline, month 1, 3, and 6

    Tear Breakup Time (TBUT): TBUT is a diagnostic test used to evaluate the stability of the tear film and diagnose dry eye disease. It measures the time it takes for dry spots to appear on the corneal surface after blinking while using a fluorescent dye. A shorter TBUT indicates less stable tear film, which is often associated with dry eye disease.

  4. SchirmerI

    Time frame: Baseline, month 1, 3, and 6

    The Schirmer I test assesses tear production to diagnose dry eye syndrome. The length of the wetting is measured in millimeters. A lower measurement indicates reduced tear production, suggesting dry eye disease.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Wu, Doctor

CONTACT

[email protected]

8613810988682

Haihong Lian, Doctor

CONTACT

[email protected]

8618811612190

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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