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NCT Number: NCT06685211

Electrical Stimulation for Vision Neuroenhancement in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location status: Recruiting

Location contact

Jeffrey Goldberg, MD PhD

PRINCIPAL_INVESTIGATOR

Study Team

CONTACT

[email protected]

650-497-5942

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sham rtACS

Device

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

Primary outcomes

  1. Visual Field Index (VFI)

    Time frame: 3 Months

    Measuring the change in the Visual Field Index (VFI) from baseline to month 3.

  2. Mean Deviation (MD)

    Time frame: 3 Months

    Measuring the change in Mean Deviation on Visual Field from Baseline to Month 3.

  3. Pointwise Linear Regression (PLR)

    Time frame: 3 Months

    Measuring the PLR of the visual field points from baseline to Month 3.

Secondary outcomes

  1. Ganglion Cell Layer

    Time frame: 3 Months

    The change in ganglion cell layer as measured by optical coherence tomography (OCT) through 3 months

  2. Retinal Nerve Fiber Layer

    Time frame: 3 Months

    The change in nerve fiber layer thickness as measured by OCT through 3 months

  3. Best Corrected Visual Acuity

    Time frame: 3 Months

    The change in best corrected visual acuity (BCVA) through 3 months

  4. Stead-State Visually Evoked Potential

    Time frame: 3 Months

    The change in visual evoked potential (VEP) through 3 months

  5. OCT-Angiography

    Time frame: 3 Months

    The change in OCT angiography (OCT-A) through 3 months

  6. Retinal Metabolic Analysis

    Time frame: 3 Months

    The change in retinal metabolic analysis (RMA)/OcuMet imaging through 3 months

  7. Visual Field indicies in Non-Study Eye

    Time frame: 3 Months

    Change in visual field indices in non-study eye through 3 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Team

CONTACT

[email protected]

650-497-5942

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • EYETRONIC, Inc

Registry information

Official study title

A Randomized, Sham Controlled, Masked Study to Evaluate the Efficacy of Alternating Current Stimulation Using the Eyetronic System for the Treatment of Glaucoma

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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