Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye

Recruiting now · Not applicable

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT06696625

Run by

Beijing Tongren Hospital

People needed

256

Starts

2021-07-01

Expected to finish

2025-12-01

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• China Beijing TongRen Hospital, Capital Medical University Beijing, China — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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