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

Last updated: August 6, 2024
Sponsor: Beijing Tongren Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Sjogren's Syndrome

Eyelid Inflammation

Blepharitis

Treatment

Hyaluronic acid eye drops

taVNS

Clinical Study ID

NCT06544447
taVNS-DE-2024
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >=18 and Age <=65.

  2. Clinical diagnosis of dry eye disease with meibomian gland dysfunction.

Exclusion

Exclusion Criteria:

  1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.

  2. History of Otorhinolaryngology surgery.

  3. Pregnant or lactating women.

Study Design

Total Participants: 135
Treatment Group(s): 2
Primary Treatment: Hyaluronic acid eye drops
Phase: 1/2
Study Start date:
June 01, 2021
Estimated Completion Date:
October 01, 2024

Connect with a study center

  • China Beijing TongRen Hospital, Capital Medical University Beijing, China

    Beijing, Beijing 100730
    China

    Active - Recruiting

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