Electrical Stimulation for Vision Neuroenhancement in Glaucoma

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma; Glaucoma Open-Angle
• Intervention / Treatment: Device: Eyetronic rtACS; Device: Sham rtACS

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Team; Phone Number: 650-497-5942; Email: glaucomatrials@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Recruiting
      • Byers Eye Institute at Stanford University
      • Contact: Study Team; Phone Number: 650-497-5942; Email: zacwenn@stanford.edu
      • Principal Investigator: Jeffrey Goldberg, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rtACS treatment; Participants will receive 10 days of rtACS treatment in office.	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.
Placebo Comparator: Sham; Participants will be wearing device but no stimulation will occur for 10 treatments in office.	Device: Sham rtACS; Participants will wear the Eyetronic system but there will be no active stimulations applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Field Index (VFI)	Measuring the change in the Visual Field Index (VFI) from baseline to month 3.	3 Months
Mean Deviation (MD)	Measuring the change in Mean Deviation on Visual Field from Baseline to Month 3.	3 Months
Pointwise Linear Regression (PLR)	Measuring the PLR of the visual field points from baseline to Month 3.	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ganglion Cell Layer	The change in ganglion cell layer as measured by optical coherence tomography (OCT) through 3 months	3 Months
Retinal Nerve Fiber Layer	The change in nerve fiber layer thickness as measured by OCT through 3 months	3 Months
Best Corrected Visual Acuity	The change in best corrected visual acuity (BCVA) through 3 months	3 Months
Stead-State Visually Evoked Potential	The change in visual evoked potential (VEP) through 3 months	3 Months
OCT-Angiography	The change in OCT angiography (OCT-A) through 3 months	3 Months
Retinal Metabolic Analysis	The change in retinal metabolic analysis (RMA)/OcuMet imaging through 3 months	3 Months
Visual Field indicies in Non-Study Eye	Change in visual field indices in non-study eye through 3 months.	3 Months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: EYETRONIC, Inc
• Investigators: Principal Investigator: Jeffrey L Goldberg, MD PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 9, 2024
• First Submitted That Met QC Criteria: November 9, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: open-angle glaucoma; glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 76900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No