Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye
ConditionDry Eye Disease
Trial statusRecruiting
Trial phaseNot applicable
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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
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.
0.1% sodium hyaluronate eye drop
DrugParticipants received 0.1% sodium hyaluronate eye drop (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany).
Treatment groups
256 Participants
are divided into 2 treatment groupsGroup A: taVNS groupExperimental treatment 2 interventions
Group B: Control GroupSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
OSDI
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).
Time frame
Baseline, month 1, 3, and 6Secondary outcomes
1
TBUT
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps' photos over time. A TBUT under 10 seconds is considered abnormal.
Time frame
Baseline, month 1, 3, and 62
Schirmer
The Schirmer test is objectively used to measure tear secretion without anesthetized. A healthy eye should wet more than 10 mm of the standard filter strip in 5 minutes. The travel rate along the test strip is proportional to the tear production rate.
Time frame
Baseline, month 1, 3, and 63
CFS
Corneal Fluorescein Staining (CFS) was measured using the National Eye Institute (NEI) scale, which ranges from 0 (no staining) to 3 (heavy staining) for each of the 5 areas of the cornea (inferior, superior, central, nasal, and temporal). The total score ranging from 0 to 15 is the sum of the 5 regions, with higher scores indicating greater symptom severity.
Time frame
Baseline, month 1, 3, and 64
DEQ-5
The 5-Item Dry Eye Questionnaire (DEQ-5) contains five questions regarding the frequency and intensity of eye discomfort, eye dryness and watery eyes in the past month. The score ranges from 0 to 22, a score \> 6 suggests dry eye, with higher scores indicating greater symptom severity.
Time frame
Baseline, month 1, 3, and 6Sponsors and contacts
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Source ClinicalTrials.gov