Electrical stimulation to improve vision 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

This trial will test whether a noninvasive transorbital alternating current stimulation device (EYETRONIC rtACS) can improve vision in adults with moderate open-angle glaucoma.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Stanford University (other)
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT06685211 on ClinicalTrials.gov

What this trial studies

This interventional study gives adults with moderate open-angle glaucoma sessions of transorbital alternating current stimulation delivered by the EYETRONIC device or a sham procedure. Eligible participants have a Humphrey Visual Field 24-2 mean deviation between -6 and -20 and clinically stable intraocular pressure under 18 mmHg, and one qualifying eye is selected for treatment. Participants receive scheduled stimulation visits and follow-up assessments to monitor visual function and safety. All treatments and assessments are performed at the Byers Eye Institute at Stanford University.

Who should consider this trial

Good fit: Adults (18+) with primary open-angle glaucoma, stable IOP below 18 mmHg, and a Humphrey 24-2 mean deviation between -6 and -20 who can attend study visits are ideal candidates.

Not a fit: People with very advanced visual field loss (MD worse than -20), uncontrolled eye pressure, or other significant ocular comorbidities are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, the device could improve visual function or slow vision loss for people with moderate open-angle glaucoma.

How similar studies have performed: Small pilot studies of transorbital or alternating current visual stimulation have reported occasional visual improvements, but overall evidence is limited and not yet definitive.

Eligibility criteria

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.

Where this trial is running

Palo Alto, California

• Byers Eye Institute at Stanford University — Palo Alto, California, United States (RECRUITING)

Study contacts

• Principal investigator: Jeffrey L Goldberg, MD PhD — Stanford University
• Study coordinator: Study Team

Conditions: Glaucoma, Glaucoma Open-Angle, glaucoma, open-angle glaucoma