Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Auricular Vagus Nerve Stimulation, Hyaluronic acid eye drops.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease: A Randomized Clinical Trial
Overview
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.
Interventions
- Device Transcutaneous Auricular Vagus Nerve Stimulation
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 affe - Drug Hyaluronic acid eye drops
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 outcome measures
- OSDI [Time frame: Baseline, month 1, 3, and 6]
Secondary outcome measures (5)
- TBUT [Time frame: Baseline, month 1, 3, and 6]
- Schirmerl [Time frame: Baseline, month 1, 3, and 6]
- Corneal fluorescein staining (tCFS) [Time frame: Baseline, month 1, 3, and 6]
- Meibomian Gland Dysfunction Score [Time frame: Baseline, month 1, 3, and 6]
- Psychological status [Time frame: Baseline, month 3, 6 and 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Beijing Tongren Hospital — Beijing
- Wu Dong — Beijing
Identifiers
NCT: NCT04673643 · taVNS-DED-2020