NCT06685211 · Stanford University
Electrical Stimulation for Vision Neuroenhancement in Glaucoma
What this study is about
The purpose of the study is to evaluate the effectiveness, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma.
View original scientific description
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.
Interventions
DEVICE
Eyetronic rtACS
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.
DEVICE
Sham rtACS
Participants will wear the Eyetronic system but there will be no active stimulations applied.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Where
- Palo Alto, California
Collaborators
EYETRONIC, Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 4, 2025 · Source of record for eligibility and locations