Electrical Stimulation for Glaucoma

Overseen By Study Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Acyclovir, Systemic steroids

Disqualifiers: Ocular herpes zoster, Uveitis, Pregnancy, Epileptic seizure, others

Compensation: Varies

Number of Visits: 10

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Eyetronic rtACS, a device for electrical stimulation, to determine its effectiveness for glaucoma, a condition that damages the optic nerve and can lead to vision loss. Participants will receive either real electrical stimulation or a placebo (a non-active treatment) to compare effects. The goal is to discover if the Eyetronic device can improve vision outcomes for those with primary open-angle glaucoma. Individuals with this type of glaucoma and stable eye pressure might be suitable for the trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for glaucoma.

Will I have to stop taking my current medications?

The trial requires that you stop taking acyclovir and related products before joining and during the study. You also cannot be on systemic steroids or other immunosuppressive medications.

What prior data suggests that this device is safe for treating glaucoma?

Research has shown that electrical stimulation treatments, such as the Eyetronic rtACS, are generally safe for people with glaucoma. Studies have found that this treatment can improve vision problems caused by glaucoma. The device uses a mild electrical charge, which the eye and brain usually tolerate well. No serious side effects have been reported in studies, suggesting the treatment is safe for most people. However, discussing any concerns with a doctor remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for glaucoma, which typically include eye drops, laser treatments, or surgery to reduce eye pressure, the Eyetronic rtACS offers a unique approach by using electrical stimulation. This method involves delivering mild electrical currents to the eye area, which researchers believe might help improve blood flow and potentially protect the optic nerve. Researchers are excited about this treatment because it could offer a non-invasive, drug-free option that might work in tandem with existing therapies to preserve vision and slow the progression of glaucoma.

What evidence suggests that the Eyetronic rtACS is effective for glaucoma?

Research has shown that the Eyetronic rtACS device, which participants in this trial may receive, can help people with glaucoma by stimulating the optic nerve. Studies suggest that this treatment might stop vision loss and, in some cases, even restore some lost vision. In Europe, authorities have approved the Eyetronic device to slow down vision loss for at least a year. Previous studies using similar electrical stimulation treatments improved vision problems in patients with primary open-angle glaucoma. These findings offer hope for those considering this treatment. ^{1 2 3 4 6}

Who Is on the Research Team?

Jeffrey L Goldberg, MD PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with open-angle glaucoma, a common eye condition that can lead to vision loss. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

Participant's eye pressure must be clinically stable, with IOP < 18.

If a participant has two eyes meeting study criteria, the worse eye will be deemed includable.

Participant must understand and sign the informed consent.

Exclusion Criteria

Participant has a history of ocular herpes zoster.

Participant is currently participating in or has recently participated in another clinical trial.

Participant is pregnant or lactating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 days of rtACS treatment in office

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Eyetronic rtACS

Trial Overview The trial is testing the effectiveness of a treatment called transorbital alternating current stimulation (rtACS) using a device named EYETRONIC. It's compared against a sham rtACS, which is like a placebo where no actual stimulation is given.

How Is the Trial Designed?

Group I: rtACS treatment Experimental Treatment 1 Intervention

Participants will receive 10 days of rtACS treatment in office.

Group II: Sham Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Neuromodtronic, GmbH

Collaborator

Trials

1

Recruited

30+

EYETRONIC, Inc

Collaborator

Published Research Related to This Trial

In a study involving 78 eyes from 46 patients with open-angle glaucoma, transpalpebral electrical stimulation significantly reduced intraocular pressure (IOP) from a baseline of approximately 19.25 mmHg to 14.41 mmHg after four months of treatment (P < 0.0001).

The treatment was effective for both patients already on maximum tolerated medical treatment and treatment-naïve patients, demonstrating a significant reduction in IOP for both groups, indicating its potential as a non-invasive therapeutic option for managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpalpebral Electrical Stimulation as a Novel Therapeutic Approach to Decrease Intraocular Pressure for Open-Angle Glaucoma: A Pilot Study. Gil-Carrasco, F., Ochoa-Contreras, D., Torres, MA., et al.[2022]

Noninvasive repetitive transorbital alternating current stimulation (rtACS) significantly improved detection ability in the visual field of patients with optic nerve damage, with a 41.1% increase compared to only 13.6% in the sham group, indicating its efficacy in vision restoration.

Patients receiving rtACS also reported greater improvements in vision-related quality of life, particularly in the 'general vision' subscale of the NEI-VFQ, suggesting that while visual field changes are important, other factors also influence overall quality of life related to vision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive transorbital alternating current stimulation improves subjective visual functioning and vision-related quality of life in optic neuropathy. Gall, C., Sgorzaly, S., Schmidt, S., et al.[2022]

In a study of 54 patients with severe dry eye syndrome, the SmartPlug showed significant long-term efficacy, with 60.4% of patients reporting decreased use of lubricant eye drops and 75.8% experiencing symptom improvement after an average follow-up of 13 months.

While the SmartPlug is effective, there are potential complications, including canaliculitis in 6.6% of cases, highlighting the need for long-term monitoring of patients after insertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SmartPlug in the management of severe dry eye syndrome. Chen, SX., Lee, GA.[2018]

Transcorneal electrical stimulation was evaluated in 5 eyes of 4 male subjects with primary open-angle glaucoma, showing a significant positive relationship between the number of treatments and improvements in visual field defects, suggesting potential efficacy.

Despite no significant changes in intraocular pressure, the treatment may help improve glaucomatous visual field defects, indicating a need for larger studies to confirm these promising preliminary results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Transcorneal Electrical Stimulation for the Treatment of Primary Open-angle Glaucoma: A Pilot Study. Ota, Y., Ozeki, N., Yuki, K., et al.[2018]

Citations

1. glaucoma.org glaucoma.org/articles/new-non-invasive-glaucoma-treatment-offered-for-first-time-in-u-s

New Non-Invasive Glaucoma Treatment Offered For First ... Optic nerve stimulation with the Eyetronic device has been shown to halt vision loss and in some cases even reverse damage so that some vision ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8969331/

Electrical neurostimulation in glaucoma with progressive ... It was concluded that electrical stimulation treatment may improve glaucomatous visual field defects in POAG. All three studies applied active ...

3. ophthalmologytimes.com ophthalmologytimes.com/view/first-us-patient-receives-eyetronic-glaucoma-treatment-at-glaucoma-center-of-san-francisco

First US patient receives Eyetronic glaucoma treatment at ... Optic nerve stimulation with the Eyetronic device has been shown to halt vision loss and, in some cases, even reverse damage so that some vision ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06693882

Electrical Stimulation of the Optic Nerve in Patients With ... Eyetronic is approved in Europe for the treatment of glaucoma to possibly delay progression of visual field (VF) loss for at least 12 months. The indication for ...

5. clinicaltrial.be clinicaltrial.be/en/details/458351?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Electrical Stimulation for Vision Neuroenhancement in Gla... The purpose of the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients ...

6. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/e/NCT05626491.html

Electrical Stimulation for the Treatment of Glaucoma The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of ...