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NCT07831876PHASE1Recruiting

A Study of Ear Nerve Stimulation to Treat Eye Inflammation

Memorial Sloan Kettering Cancer Center

Start Date

9/9/2026

Completion Date

9/9/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Cymbathera One System

Interested in This Trial?

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Conditions

Ocular InflammationCrystalline Lens; ChalcosisIntraocular Lens Complication

Locations

Memorial Sloan Kettering at Basking Ridge (Consent Only)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York 10065

United States

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York 11553

United States