Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease With Meibomian Gland Dysfunction, A Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- OSDI
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age >=18 and Age <=
- •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.
Arms & Interventions
taVNS group
Intervention: taVNS (Device)
taVNS group
Intervention: Hyaluronic acid eye drops (Drug)
Control Group
Intervention: taVNS (Device)
Control Group
Intervention: Hyaluronic acid eye drops (Drug)
Outcomes
Primary Outcomes
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
- OPAS(Baseline, month 1, 3, and 6)
- NPSI-eye(Baseline, month 1, 3, and 6)
- SchirmerI(Baseline, month 1, 3, and 6)
- TBUT(Baseline, month 1, 3, and 6)