Electrical Stimulation for Glaucoma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Glaucoma Center of San Francisco

Disqualifiers: Migraine, Epilepsy, Brain tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Eyetronic Nextwave System, a device delivering gentle electrical pulses to the optic nerve, can slow vision loss in people with glaucoma. The main goal is to determine if this treatment can prevent the disease from worsening. Individuals diagnosed with glaucoma who have experienced some vision changes, but not complete vision loss, may find this trial suitable. Participants will attend several visits over a year to receive treatment and monitor any changes in their vision. 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 protocol does not specify if you need to stop taking your current medications. However, if you started any eye pressure-lowering medication less than six months before joining, you may not be eligible.

What prior data suggests that the Eyetronic Nextwave System device is safe for treating glaucoma?

Studies have shown that the EYETRONIC Nextwave System is generally safe for people with glaucoma. Over 1,000 patients in Europe have used this treatment without any serious side effects reported. This suggests that the system's method of stimulating the optic nerve is well-tolerated. The treatment's approval in Europe for glaucoma further supports its safety. While the device aims to slow vision loss in glaucoma, its widespread use without major issues is encouraging for new participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The EYETRONIC Nextwave System is unique because it uses electrical stimulation of the optic nerve to address glaucoma. Most current treatments for glaucoma, like eye drops, laser therapy, or surgery, focus on reducing intraocular pressure to prevent further damage. However, this treatment takes a different approach by directly stimulating the optic nerve, potentially enhancing nerve function and slowing the progression of the disease. Researchers are excited because this could offer a novel way to preserve vision without relying solely on pressure reduction methods.

What evidence suggests that the Eyetronic Nextwave System is effective for glaucoma?

Research has shown that the Eyetronic Nextwave System, which uses electrical signals on the optic nerve, may help with glaucoma. Some studies found that it might stop or even reverse vision loss. In Europe, it has already been approved to possibly delay vision loss for at least a year. Early results suggest it could improve vision problems in people with glaucoma. In this trial, all participants will undergo electrical stimulation of the optic nerve using the Eyetronic Nextwave System. This treatment offers a new way to address vision issues by stimulating the optic nerve externally. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with glaucoma who are interested in a non-drug treatment option. Participants will need to attend multiple study visits over the course of a year.

Inclusion Criteria

Humphrey visual field MD values between -6 dB and -20 dB

I am 18 or older with glaucoma.

Exclusion Criteria

I have recently experienced bleeding in my eye.

Metallic artifacts in the head (except dentures)

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo electrical stimulation of the optic nerve with the Eyetronic Nextwave System device

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Approximately 4-8 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• EYETRONIC Nextwave System

Trial Overview The Eyetronic Nextwave System, which electrically stimulates the optic nerve through the facial skin, is being tested to see if it can slow down vision loss in glaucoma patients.

How Is the Trial Designed?

Group I: Patients with glaucoma undergoing electrical stimulation of the optic nerve Experimental Treatment 1 Intervention

Single arm study of patients with glaucoma undergoing electrical stimulation of the optic nerve

Who Is Running the Clinical Trial?

Glaucoma Center of San Francisco

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

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]

The iTEAR device, a portable sonic neuromodulation tool, significantly improved tear production and symptoms in patients with dry eye disease, with a notable increase in the Schirmer index and a reduction in Ocular Surface Disease Index scores after 30 days of use.

The study involved 101 participants and demonstrated both safety and efficacy, with only two mild adverse events reported, indicating that iTEAR could be a viable treatment option for dry eye disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Extranasal Tear Stimulation: Pivotal Study Results. Ji, MH., Moshfeghi, DM., Periman, L., et al.[2022]

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]

Citations

1. 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 ...

2. 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 ...

3. 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 ...

4. 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 ... Eyetronic therapy offers a novel approach by electrically stimulating the optic nerve, potentially reversing vision loss in patients with ...

5. withpower.com withpower.com/trial/phase-glaucoma-2025-d776b

Electrical Stimulation for Glaucoma · Info for Participants Research suggests that transcorneal electrical stimulation, similar to the EYETRONIC Nextwave System, may improve visual field defects in glaucoma patients, as ...

6. biospace.com biospace.com/eyetronic-therapy-new-study-proves-long-term-effect

Eyetronic Therapy: New Study Proves Long-Term Effect The treatment with the Eyetronic system resulted in a stop of the progression of glaucoma in approximately 75% of patients one year after the therapy.