Electrical Stimulation for Vision Neuroenhancement in Glaucoma

NCT06685211 | Recruiting FDA Device

• 1 other identifier: 76900
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

glaucoma; open-angle glaucoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Ganglion Cell Layer

  3 Months

• Retinal Nerve Fiber Layer

  3 Months

• Best Corrected Visual Acuity

  3 Months

• Stead-State Visually Evoked Potential

  3 Months

• OCT-Angiography

  3 Months

Study Arms (2)

rtACS treatment

EXPERIMENTAL

Participants will receive 10 days of rtACS treatment in office.

Device: Eyetronic rtACS

Sham

PLACEBO COMPARATOR

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

Device: Sham rtACS

Interventions

Eyetronic rtACS DEVICE

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.

rtACS treatment

Sham rtACS DEVICE

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

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Stanford University: lead
• EYETRONIC, Inc: collaborator

Study Sites (1)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Jeffrey L Goldberg, MD PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Team

CONTACT

650-497-5942; glaucomatrials@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Ophthalmology

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: July 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

US (1)