Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease
ConditionDry Eye Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tongren Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >=18 and Age <=75.
Clinical diagnosis of dry eye disease.
Disqualifiers
History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
History of phthalmology surgery.
Pregnant or lactating women.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Auricular Vagus Nerve Stimulation
DevicetaVNS 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.
Hyaluronic acid eye drops
DrugParticipants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: taVNS groupExperimental treatment 2 interventions
Group B: Control GroupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
OSDI
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.
Time frame
Baseline, month 1, 3, and 6Secondary outcomes
1
TBUT
Tear Breakup Time (TBUT): TBUT is a diagnostic test used to evaluate the stability of the tear film and diagnose dry eye disease. It measures the time it takes for dry spots to appear on the corneal surface after blinking while using a fluorescent dye. A shorter TBUT indicates less stable tear film, which is often associated with dry eye disease.
Time frame
Baseline, month 1, 3, and 62
Schirmerl
The Schirmer I test assesses tear production to diagnose dry eye syndrome. The length of the wetting is measured in millimeters. A lower measurement indicates reduced tear production, suggesting dry eye disease.
Time frame
Baseline, month 1, 3, and 63
Corneal fluorescein staining (tCFS)
tCFS used to assess the damage to the corneal epithelium, particularly in cases of dry eye disease, ocular surface disorders, or trauma.
Time frame
Baseline, month 1, 3, and 64
Meibomian Gland Dysfunction Score
MGD score used to assess the function of the Meibomian glands and the overall health of the eyelid margins.
Time frame
Baseline, month 1, 3, and 6Sponsors and contacts
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Source ClinicalTrials.gov