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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment EYETRONIC Nextwave System for glaucoma?

Research suggests that transcorneal electrical stimulation, similar to the EYETRONIC Nextwave System, may improve visual field defects in glaucoma patients, as shown by a significant positive relationship between treatment frequency and visual field improvement. However, larger studies are needed to confirm these findings. ^{1 2 3 4 5}

Is electrical stimulation generally safe for humans?

In studies involving electrical stimulation for eye conditions like glaucoma and macular degeneration, no significant safety issues were reported. These treatments have been used in clinical settings under FDA guidance, suggesting they are generally safe for human use. ^{1 2 5 6 7}

How does the EYETRONIC Nextwave System treatment for glaucoma differ from other treatments?

The EYETRONIC Nextwave System uses electrical stimulation, which is unique because it involves applying electric currents to the eye to potentially improve visual field defects in glaucoma patients. Unlike traditional treatments that focus on lowering eye pressure, this method aims to enhance visual function through neurostimulation. ^{1 2 5 8 9}

What is the purpose of this trial?

The goal of this observational study is to evaluate electrical stimulation of the optic nerve with the Eyetronic Nextwave System device as a possible treatment for glaucoma. The main question it aims to answer is: Could this therapy be an option to counteract the loss of visual field seen in glaucoma and thus delay the progression of the disease? Participants will have approximately 14-18 study visits during 12 months including 10 visits for the electrical stimulation treatment. The treatment involves electrically stimulating the optic nerve by an external approach via the facial skin.

Eligibility Criteria

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

Implanted electronic devices

Metallic artifacts in the head (except dentures)

I have high blood pressure that is not being treated.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

The Efficacy of Transcorneal Electrical Stimulation for the Treatment of Primary Open-angle Glaucoma: A Pilot Study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Electrical neurostimulation in glaucoma with progressive vision loss. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Electrical devices for visual restoration. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Novel Extranasal Tear Stimulation: Pivotal Study Results. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Transpalpebral Electrical Stimulation as a Novel Therapeutic Approach to Decrease Intraocular Pressure for Open-Angle Glaucoma: A Pilot Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Electrotherapeutic device/protocol design considerations for visual disease applications. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

SmartPlug in the management of severe dry eye syndrome. [2018]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Effect of ciliary muscle electrical stimulation on ocular hydrodynamics and visual function in patients with glaucoma]. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

neuroBi: A Highly Configurable Neurostimulator for a Retinal Prosthesis and Other Applications. [2020]