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

Stanford University1 site in 1 country30 target enrollmentJuly 14, 2025

ConditionsGlaucoma Glaucoma Open-Angle

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glaucoma
Sponsor: Stanford University
Enrollment: 30
Locations: 1
Primary Endpoint: Visual Field Index (VFI)
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 14, 2025

End Date

December 31, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Jeffrey L Goldberg

Professor and Chair of Ophthalmology

Stanford University

Eligibility Criteria

Inclusion Criteria

•Participant must be at least
•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 \<
•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.