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NCT Number: NCT04673643

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Tongren Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >=18 and Age <=75.
  • Clinical diagnosis of dry eye disease.

Exclusion criteria

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

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

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. 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.

  2. Schirmerl

    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.

  3. Corneal fluorescein staining (tCFS)

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

    tCFS used to assess the damage to the corneal epithelium, particularly in cases of dry eye disease, ocular surface disorders, or trauma.

  4. Meibomian Gland Dysfunction Score

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

    MGD score used to assess the function of the Meibomian glands and the overall health of the eyelid margins.

  5. Psychological status

    Time frame: Baseline, month 3, 6 and 12

    9-item Patient Health Questionnaire and Symptom Checklist-90 for anxiety are used to assess the psychological status.

Study contacts

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

Dong Wu

CONTACT

[email protected]

8615810333520

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2020
Registry last updated
Sep 19, 2024

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

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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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