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NCT Number: NCT06696625

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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.
  • 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 criteria

  • 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.

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.

0.1% sodium hyaluronate eye drop

Drug

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

Primary outcomes

  1. OSDI

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

    The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eye (33-100).

Secondary outcomes

  1. TBUT

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

    Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT,

    fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed

    under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between

    the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps' photos over time. A TBUT under 10 seconds is considered abnormal.

  2. Schirmer

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

    The Schirmer test is objectively used to measure tear secretion without anesthetized. A healthy eye should wet more than 10 mm of the standard filter strip in 5 minutes. The travel rate along the test strip is proportional to the tear production rate.

  3. CFS

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

    Corneal Fluorescein Staining (CFS) was measured using the National Eye Institute (NEI) scale, which ranges from 0 (no staining) to 3 (heavy staining) for each of the 5 areas of the cornea (inferior, superior, central, nasal, and temporal).

    The total score ranging from 0 to 15 is the sum of the 5 regions, with higher scores indicating greater symptom severity.

  4. DEQ-5

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

    The 5-Item Dry Eye Questionnaire (DEQ-5) contains five questions regarding the frequency and intensity of eye discomfort, eye dryness and watery eyes in the past month. The score ranges from 0 to 22, a score > 6 suggests dry eye, with higher scores indicating greater symptom severity.

  5. PHQ-9

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

    Depression was assessed with the 9-item Patient Health Questionnaire (PHQ). Patients were classified as having no depression (PHQ score: 0-4), mild (PHQ, score: 5-9), and moderate to severe depression (PHQ score: 10-27). Scores range from 0 to 27, with higher scores indicating greater symptom severity.

  6. SF-36

    Time frame: Baseline, month 3, 6 and 12

    36-Item Short Form Health Survey (SF36) measures quality of life on the basis of eight dimensions or concepts

    that are frequently used in health studies. These eight dimensions are estimated from eight subscales that examine

    physical functioning (SF36-PF), role functioning-physical (SF36-RP), bodily pain (SF36-BP), general health (SF36-

    GH), vitality (SF36-VT), social functioning (SF36-SF), role functioning-emotional (SF36-RE), mental health (SF36-MH)

    and reported health transition (SF36-HT). Item responses were ranging from 0 (best) to 100 (worst), with higher scores are equivalent to greater severity of better quality of life.

Study contacts

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

Dong Wu, Doctor

CONTACT

[email protected]

8613810988682

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2024
Registry last updated
Nov 20, 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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