Dysautonomia International

A Study of Ear Nerve Stimulation to Treat Eye Inflammation

Purpose

The purpose of this study to find out whether a device that delivers mild electrical stimulation to the ear (transcutaneous auricular vagus nerve stimulation, or taVNS) can reduce inflammation in the eye in people with ocular inflammatory conditions. The device is called the Cymbathera One System.

Conditions

Ocular Inflammation
Crystalline Lens; Chalcosis
Intraocular Lens Complication

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Age ≥18 years - Ocular inflammatory condition-specifically, at least 1 eye with intra/subretinal fluid or both eyes with an inflammatory ocular surface condition - Able to attend all study visits at approximately the same time of day (within a 3-h window) For participants in the intra/subretinal fluid group: - The presence of a natural crystalline lens or intraocular lens - Pupils that can dilate to at least 3 mm in the study eye(s) - The absence of opaque natural crystalline lenses or the presence of any ocular disease that prevents the view of the retina for imaging

Exclusion Criteria

Having or exhibiting any of the following: - Evidence of active infection - Chronically implanted electronic medical device, including pacemakers, defibrillators, cochlear implants, spinal stimulators, and vagus nerve stimulators - Evidence of any skin condition at the stimulation site - Untreated or poorly controlled psychiatric illness - Evidence of significant neurological conditions, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, seizure, stroke, and dementia - Low blood pressure, bradycardia, or hypoglycemia - History of bleeding disorders, including sickle cell anemia, anemia syndromes, monocytosis, and thrombocytopenia - History of vagotomy - History of partial or complete splenectomy - History of HIV infection or AIDS - History of recurrent vasovagal syncope episodes - Receipt of any of the following medications within 1 week of the first visit: - Anticholinergic (Benadryl) - Antihypertensive (α-methyldopa) - Epinephrine-related drugs, norepinephrine-related drugs, and drugs that stimulate release of epinephrine and/or norepinephrine (Micronefrin, Asthmanefrin) - Alpha and/or beta adrenoceptor blocking agents - Antiseizure medications - Other medications, supplements, etc. that may interfere with the study results - Substance abuse (alcoholism or other) problem - Consumption of alcohol within 1 day of a study visit - Currently using or have used recreational drugs, tobacco, and/or nicotine products within 1 week of the first visit

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Diagnostic
Masking: None (Open Label)