Electrical Stimulation for Glaucoma

Overseen By Study Team

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Eyetronic rtACS for glaucoma?

Research suggests that electrical stimulation treatments, like transcorneal electrical stimulation, may improve visual field defects in glaucoma patients. Additionally, similar treatments, such as transorbital alternating current stimulation, have shown improvements in visual functioning and quality of life in patients with optic nerve damage. ^{1 2 3 4 5}

Is electrical stimulation safe for treating glaucoma?

In a study with glaucoma patients, electrical stimulation was generally well-tolerated with no serious side effects reported. One minor issue was an increase in eye pressure in some patients, but it wasn't considered clinically significant. ^{2 4 5 6 7}

How does the Eyetronic rtACS treatment for glaucoma differ from other treatments?

Eyetronic rtACS is unique because it uses electrical stimulation to potentially improve visual field defects in glaucoma patients, unlike traditional treatments that primarily focus on lowering eye pressure. This approach involves applying electrical currents to the eye, which may enhance retinal cell function and survival. ^{1 2 4 8 9}

Research Team

Jeffrey L Goldberg, MD PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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. 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]

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

Noninvasive transorbital alternating current stimulation improves subjective visual functioning and vision-related quality of life in optic neuropathy. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Transcorneal electrical stimulation in primary open angle glaucoma]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Electrical neurostimulation in glaucoma with progressive vision loss. [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. United States pubmed.ncbi.nlm.nih.gov

Transcorneal Electrical Stimulation Inhibits Retinal Microglial Activation and Enhances Retinal Ganglion Cell Survival After Acute Ocular Hypertensive Injury. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Visual sensations produced by optic nerve stimulation using an implanted self-sizing spiral cuff electrode. [2019]