GlaucomaNCT06685211
Electrical Stimulation for Vision Neuroenhancement in Glaucoma
A study testing Eyetronic rtACS in people with Glaucoma and Glaucoma Open-Angle, run by Stanford University at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma Open-Angle
- What is being tested?
- Eyetronic rtACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to Jun 2028
- Phase
- Interventional
- 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
- Participant must be at least 18.
- Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
- Participant's clinical diagnosis must be consistent with primary open angle glaucoma (including but not limited to normal tension, low tension or general open angle) characterized by the following features: Mean deviation (MD) worse than -6 but better than -20 on reliable Humphrey Visual Field 24-2 testing
- Participant's eye pressure must be clinically stable, with IOP < 18.
- If a participant has two eyes meeting study criteria, the worse eye as determined by visual field index (VFI) or patient preference, will be deemed includable. If both eyes qualify and have the same VFI, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study.
- Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
Who cannot join
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has a history of ocular herpes zoster.
- Participant has a requirement of acyclovir and/or related products during study duration. To be eligible for this study, the participant must discontinue use of these products prior to enrollment and must not continue with the products until after they have completed the study.
- Participant has evidence of corneal opacification or lack of optical clarity.
- Participant has uveitis or other ocular inflammatory disease.
- Participant is receiving systemic steroids or other immunosuppressive medications.
Show all 16Show fewer
- Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
- Participant is pregnant or lactating.
- Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
- Patients with opened skull, after trepanation or with heart and brain pacemaker.
- Patients with implanted intracranial metals such as clippings, coilings, ventriculo-peritoneal shunts, endoprosthesis etc.
- Patients with any skin damage in the area of electrode placement.
- Children and comatose patients.
- Patients with recent history of epileptic seizure.
- Patients with uncontrolled high levels of blood pressure (<160 mmHg) or uncontrolled high levels of intraocular pressure (<27 mmHg).
- Patients abusing drugs or alcohol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
Study Team, 6504975942, zacwenn@stanford.edu
Jeffrey Goldberg, MD PhD
About this study
Official title: A Randomized, Sham Controlled, Masked Study to Evaluate the Efficacy of Alternating Current Stimulation Using the Eyetronic System for the Treatment of Glaucoma
The purpose of the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma.
- Conditions
- Glaucoma, Glaucoma Open-Angle
- Being tested
- Eyetronic rtACS, Sham rtACS
- Keywords
- glaucoma, open-angle glaucoma
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyetronic rtACSDevice
The repetitive, transorbital alternating current stimulation (rtACS) is a device for non-invasive Interventional Neurophysiology. The electrical charge and current density applied during rtACS safe and able to modulate existing neuronal elements in the eye and brain.
Sham rtACSDevice
Participants will wear the Eyetronic system but there will be no active stimulations applied.
| Study group | Role | What they receive |
|---|---|---|
| rtACS treatment | Experimental | Participants will receive 10 days of rtACS treatment in office. Receives: Device: Eyetronic rtACS |
| Sham | Placebo comparator | Participants will be wearing device but no stimulation will occur for 10 treatments in office. Receives: Device: Sham rtACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Field Index (VFI)
Measuring the change in the Visual Field Index (VFI) from baseline to month 3.
Measured: 3 Months
Mean Deviation (MD)
Measuring the change in Mean Deviation on Visual Field from Baseline to Month 3.
Measured: 3 Months
Pointwise Linear Regression (PLR)
Measuring the PLR of the visual field points from baseline to Month 3.
Measured: 3 Months
Secondary outcomes (7)
Ganglion Cell Layer
The change in ganglion cell layer as measured by optical coherence tomography (OCT) through 3 months
Measured: 3 Months
Retinal Nerve Fiber Layer
The change in nerve fiber layer thickness as measured by OCT through 3 months
Measured: 3 Months
Best Corrected Visual Acuity
The change in best corrected visual acuity (BCVA) through 3 months
Measured: 3 Months
Stead-State Visually Evoked Potential
The change in visual evoked potential (VEP) through 3 months
Measured: 3 Months
OCT-Angiography
The change in OCT angiography (OCT-A) through 3 months
Measured: 3 Months
Retinal Metabolic Analysis
The change in retinal metabolic analysis (RMA)/OcuMet imaging through 3 months
Measured: 3 Months
Visual Field indicies in Non-Study Eye
Change in visual field indices in non-study eye through 3 months.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start14 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- EYETRONIC, Inc
- Responsible party
- Principal investigator, Jeffrey L Goldberg, Stanford University
- Investigators
- Jeffrey L Goldberg, MD PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685211
- Sponsor's protocol ID
- 76900
- Status last verified
- Oct 2026
- First submitted
- 9 Nov 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham Controlled, Masked Study to Evaluate the Efficacy of Alternating Current Stimulation Using the Eyetronic System for the Treatment of Glaucoma
- ClinicalTrials.gov ID
- NCT06685211
- Acronym / sponsor ID
- 76900
- Conditions
- Glaucoma, Glaucoma Open-Angle
- Keywords
- glaucoma, open-angle glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- EYETRONIC, Inc
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Nov 2024 (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 the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rtACS treatment | Experimental | Device: Eyetronic rtACSParticipants will receive 10 days of rtACS treatment in office. |
| Sham | Placebo comparator | Device: Sham rtACSParticipants will be wearing device but no stimulation will occur for 10 treatments in office. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be at least 18.
- Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
- Participant's clinical diagnosis must be consistent with primary open angle glaucoma (including but not limited to normal tension, low tension or general open angle) characterized by the following features: Mean deviation (MD) worse than -6 but better than -20 on reliable Humphrey Visual Field 24-2 testing
- Participant's eye pressure must be clinically stable, with IOP < 18.
- If a participant has two eyes meeting study criteria, the worse eye as determined by visual field index (VFI) or patient preference, will be deemed includable. If both eyes qualify and have the same VFI, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study.
Key exclusion criteria (16 listed)
- Participant is unable to comply with study procedures or follow-up visits.
- Participant has a history of ocular herpes zoster.
- Participant has a requirement of acyclovir and/or related products during study duration. To be eligible for this study, the participant must discontinue use of these products prior to enrollment and must not continue with the products until after they have completed the study.
- Participant has evidence of corneal opacification or lack of optical clarity.
- Participant has uveitis or other ocular inflammatory disease.
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 |
|---|---|---|
| Eyetronic rtACSThe repetitive, transorbital alternating current stimulation (rtACS) is a device for non-invasive Interventional Neurophysiology. The electrical charge and current density applied during rtACS safe and able to modulate existing neuronal elements in the eye and brain. | Device | rtACS treatment |
| Sham rtACSParticipants will wear the Eyetronic system but there will be no active stimulations applied. | Device | Sham |
Primary outcome
Visual Field Index (VFI)
Time frame: 3 Months
Measuring the change in the Visual Field Index (VFI) from baseline to month 3.
Mean Deviation (MD)
Time frame: 3 Months
Measuring the change in Mean Deviation on Visual Field from Baseline to Month 3.
Pointwise Linear Regression (PLR)
Time frame: 3 Months
Measuring the PLR of the visual field points from baseline to Month 3.
7 secondary outcomes
Ganglion Cell Layer
Time frame: 3 Months
Retinal Nerve Fiber Layer
Time frame: 3 Months
Best Corrected Visual Acuity
Time frame: 3 Months
Stead-State Visually Evoked Potential
Time frame: 3 Months
OCT-Angiography
Time frame: 3 Months
Retinal Metabolic Analysis
Time frame: 3 Months
Visual Field indicies in Non-Study Eye
Time frame: 3 Months
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 9 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
Jeffrey L Goldberg, MD PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyetronic rtACS in people with Glaucoma and Glaucoma Open-Angle, run by Stanford University at 1 site 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 6 inclusion and 16 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Study Team (650-497-5942, glaucomatrials@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Field Index (VFI) (time frame: 3 Months). The study lists 3 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 9 Oct 2026.