Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye

Launched by BEIJING TONGREN HOSPITAL · Nov 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcutaneous auricular vagus nerve stimulation (taVNS) to see if it can help people with dry eye disease. The trial is currently looking for participants at Beijing Tongren Hospital and aims to include 256 patients. To be eligible, you need to be between 18 and 65 years old, have been experiencing dry eye symptoms for at least six months, and have specific scores on tests that measure your eye health.

If you decide to participate, you will complete several questionnaires and eye tests at the beginning of the study, and then again at one, three, and six months later to track your progress. This trial is open to all genders, and it’s important to note that individuals with certain health issues, like autoimmune diseases or active eye infections, cannot participate. This study aims to find out if taVNS can improve symptoms for those suffering from dry eye disease, potentially offering a new option for relief.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>=18 and Age \<=65.
• • 2. complaint of DED symptoms for 6 months or longer at screening.
• • 3. ocular surface disease index (OSDI) score of 25 or higher.
• • 4. tear film breakup time (TFBUT) of 5 seconds or less.
• • 5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes.
• • 6. tCFS score of 4 or higher.
• Exclusion Criteria:
• • 1. History systemic autoimmune diseases and ocular/periocular malignancy.
• • 2. Clinically relevant slitlamp findings or abnormal lid anatomy.
• • 3. Active ocular allergies and active infection.
• • 4. Pregnant or lactating women.