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

Capital Medical University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Dry Eye

Treatments: Drug: Hyaluronic acid eye drops; Device: taVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT06544447

taVNS-DE-2024

Details and patient eligibility

About

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.

Enrollment: 135 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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135 participants in 2 patient groups

taVNS group

Experimental group

Treatment:

Device: taVNS

Drug: Hyaluronic acid eye drops

Control Group

Sham Comparator group

Treatment:

Device: taVNS

Drug: Hyaluronic acid eye drops