Recruiting

rtACS

Sponsor:

Stanford University

Code:

NCT06685211

Conditions

Glaucoma

Glaucoma Open-Angle

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eyetronic rtACS

Sham rtACS

Study Details

Brief 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.

Conditions

Glaucoma

Glaucoma Open-Angle

Study ID

NCT06685211

Start date

Jul 14, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rtACS treatment

Participants will receive 10 days of rtACS treatment in office.

placebo comparator: Sham

Participants will be wearing device but no stimulation will occur for 10 treatments in office.

Interventions

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.

Sham rtACS

Participants will wear the Eyetronic system but there will be no active stimulations applied.

Primary outcome measure

  • Visual Field Index (VFI) [ Time Frame: 3 Months ]
  • Mean Deviation (MD) [ Time Frame: 3 Months ]
  • Pointwise Linear Regression (PLR) [ Time Frame: 3 Months ]

Central Contacts and Locations

Central contacts

Study Team

650-497-5942glaucomatrials@stanford.edu

Locations

Byers Eye Institute at Stanford University

Recruiting

Palo Alto, California, United States, 94303

Contacts

Study Team

650-497-5942zacwenn@stanford.edu

Principal Investigator:

Jeffrey Goldberg, MD PhD

More Information

Sponsor

Stanford University

Last update posted

Nov 4, 2025

Last verified

Nov, 2025

Keywords

  • glaucoma
  • open-angle glaucoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-11-04.