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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether electrical stimulation around the eyes using the EYETRONIC device helps treat glaucoma, a disease that damages the eye’s main nerve. It is for adults with primary open-angle glaucoma, a certain amount of vision loss, and stable eye pressure.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You can follow study instructions and attend all required visits.
  • You have primary open-angle glaucoma, including normal- or low-pressure glaucoma.
  • Your Humphrey 24-2 vision test has a mean deviation score worse than -6 but better than -20. This score measures vision loss.
  • Your eye pressure is stable and below 18.
  • Only one eye will enter the study. If both qualify, the study uses vision scores, your choice, or a chance-based assignment to select one.
  • You understand and sign the consent form. It can be read aloud if you cannot read it because of vision loss.

Who can't join

  • You cannot follow study steps or attend follow-up visits, are in a coma, or have a physical or mental condition the study doctor believes makes participation unsafe or affects study results.
  • You have had shingles in the eye, have clouding that blocks light through the eye, or have eye inflammation.
  • You need acyclovir or related medicines during the study, or take steroids that affect the whole body or medicines that weaken the immune system.
  • You are in, or were in within the past 3 months, another drug trial involving the study eye or a drug that affects the whole body.
  • You are pregnant or breastfeeding.
  • You have an opening in your skull or have had surgery to open it, have a heart or brain pacemaker, or have metal or other listed devices implanted inside your skull.
  • You have damaged skin where the electrodes would go, or have had a recent epileptic seizure.
  • You have uncontrolled high blood pressure or eye pressure, or misuse drugs or alcohol.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CA