Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye
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, 0.1% sodium hyaluronate eye drop.
- 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: a Randomized Clinical Trial
Overview
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.
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 0.1% sodium hyaluronate eye drop
Participants received 0.1% sodium hyaluronate eye drop (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany).
Primary outcome measures
- OSDI [Time frame: Baseline, month 1, 3, and 6]
Secondary outcome measures (6)
- TBUT [Time frame: Baseline, month 1, 3, and 6]
- Schirmer [Time frame: Baseline, month 1, 3, and 6]
- CFS [Time frame: Baseline, month 1, 3, and 6]
- DEQ-5 [Time frame: Baseline, month 1, 3, and 6]
- PHQ-9 [Time frame: Baseline, month 1, 3, and 6]
- SF-36 [Time frame: Baseline, month 3, 6 and 12]
Eligibility criteria
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.
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 · 1 center
- China Beijing TongRen Hospital, Capital Medical University Beijing, China — Beijing
Identifiers
NCT: NCT06696625 · DED_taVNS_2024