Ocular InflammationPhase 1NCT07831876
A Study of Ear Nerve Stimulation to Treat Eye Inflammation
A Phase 1 study testing Cymbathera One System in people with Ocular Inflammation and Crystalline Lens; Chalcosis, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Inflammation, Crystalline Lens; Chalcosis, Intraocular Lens Complication
- What is being tested?
- Cymbathera One System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Sep 2026to 9 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, 11725
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Jasmine Francis, MD, 212-639-7266
- Recruiting
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, 11553
Jasmine Francis, MD, 212-639-7266
About this study
Official title: Assessment of Transcutaneous Auricular Vagus Nerve Stimulation for Ocular Inflammatory Conditions
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.
- Being tested
- Cymbathera One System
- Keywords
- Ocular Inflammation, Ocular inflammatory condition, intraretinal fluid, subretinal fluid, natural crystalline lens, intraocular lens, Cymbathera One System, Memorial Sloan Kettering Cancer Center, 26-317
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cymbathera One SystemDevice
Cymbathera One System provides transcutaneous electrical stimulation to the auricular branch of the vagus nerve
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Ocular Surface Group | Experimental | Participants will use the Cymbathera One System transcutaneous electrical stimulation Receives: Device: Cymbathera One System |
| Intra/subretinal fluid group | Experimental | Participants will use the Cymbathera One System transcutaneous electrical stimulation Receives: Device: Cymbathera One System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.
The primary objective is to estimate changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.
Measured: 1 year
Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with intra/subretinal fluid
The primary objective is to estimate changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with intra/subretinal fluid.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start9 Sep 2026
- Primary completion9 Sep 2028 (estimated)
- Study completion9 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular InflammationStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasmine Francis, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831876
- Sponsor's protocol ID
- 26-317
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Transcutaneous Auricular Vagus Nerve Stimulation for Ocular Inflammatory Conditions
- ClinicalTrials.gov ID
- NCT07831876
- Acronym / sponsor ID
- 26-317
- Keywords
- Ocular Inflammation, Ocular inflammatory condition, intraretinal fluid, subretinal fluid, natural crystalline lens, intraocular lens, Cymbathera One System, Memorial Sloan Kettering Cancer Center
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 9 Sep 2028 (estimated)
- Study completion
- 9 Sep 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Ocular Surface Group | Experimental | Device: Cymbathera One SystemParticipants will use the Cymbathera One System transcutaneous electrical stimulation |
| Intra/subretinal fluid group | Experimental | Device: Cymbathera One SystemParticipants will use the Cymbathera One System transcutaneous electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- The presence of a natural crystalline lens or intraocular lens
- Pupils that can dilate to at least 3 mm in the study eye(s)
Key exclusion criteria (22 listed)
- Having or exhibiting any of the following:
- Receipt of any of the following medications within 1 week of the first visit:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cymbathera One SystemCymbathera One System provides transcutaneous electrical stimulation to the auricular branch of the vagus nerve | Device | Inflammatory Ocular Surface Group, Intra/subretinal fluid group |
Primary outcome
Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.
Time frame: 1 year
The primary objective is to estimate changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease.
Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with intra/subretinal fluid
Time frame: 1 year
The primary objective is to estimate changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with intra/subretinal fluid.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jasmine Francis, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cymbathera One System in people with Ocular Inflammation and Crystalline Lens; Chalcosis, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasmine Francis, MD (212-639-7266, francij1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in clinical findings attributable to transcutaneous auricular vagus nerve stimulation (taVNS) in participants with inflammatory ocular surface disease. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.