Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 256
- 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.
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.
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 <=
- •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.
Arms & Interventions
taVNS group
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 affected ear, which is the region of rich vagus nerve branch distribution.
Intervention: Transcutaneous Auricular Vagus Nerve Stimulation (Device)
taVNS group
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 affected ear, which is the region of rich vagus nerve branch distribution.
Intervention: 0.1% sodium hyaluronate eye drop (Drug)
Control Group
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 affected ear, which is the region of rich vagus nerve branch distribution. Patients in control group were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution.
Intervention: Transcutaneous Auricular Vagus Nerve Stimulation (Device)
Control Group
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 affected ear, which is the region of rich vagus nerve branch distribution. Patients in control group were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution.
Intervention: 0.1% sodium hyaluronate eye drop (Drug)
Outcomes
Primary Outcomes
OSDI
Time Frame: Baseline, month 1, 3, and 6
The Ocular Surface Disease Index (OSDI) includes 12 questions grouped by poor symptoms and visual disturbance (light sensitivity, eyes feel gritty, painful or sore eyes, blurred vision or poor vision); visual function/tasks (problems when reading, driving at night, working on a computer or watching TV); and environmental questions (problems in windy conditions, places/areas with low humidity or areas that are air conditioned). The scores range from 0 to 100. On the basis of the score, the patient's symptoms can be categorized as normal (0-12), mild dry eye (13-22), moderate dry eye (23-32), or severe dry eye (33-100).
Secondary Outcomes
- TBUT(Baseline, month 1, 3, and 6)
- Schirmer(Baseline, month 1, 3, and 6)
- CFS(Baseline, month 1, 3, and 6)
- DEQ-5(Baseline, month 1, 3, and 6)
- PHQ-9(Baseline, month 1, 3, and 6)
- SF-36(Baseline, month 3, 6 and 12)