What side effects are associated with this type of intervention?

Common treatments for glaucoma include medications, laser therapy, and surgery. Medications, such as prostaglandin analogs, beta-blockers, and carbonic anhydrase inhibitors, can cause side effects like eye redness, stinging, blurred vision, and systemic effects like fatigue or shortness of breath. Laser therapies, such as trabeculoplasty, may lead to temporary eye irritation or increased intraocular pressure. Surgical options, like trabeculectomy, carry risks of infection, bleeding, and vision changes. For treatments similar to the home-stimulation device, such as electrical stimulation, specific side effects are not well-documented, but general risks may include discomfort, tingling, or irritation at the site of stimulation.

What prior FDA approvals exist?

The FDA has approved various treatments for glaucoma, primarily focusing on reducing intraocular pressure to slow the progression of the disease. These include medications such as prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors. While the home-stimulation device for electrical stimulation to promote nerve health or slow degeneration is still under study, it represents a novel approach that differs from traditional pharmacologic treatments. Currently, there are no FDA-approved electrical stimulation devices specifically for glaucoma, but ongoing research aims to explore their potential benefits.

What other types of research exist?

Promising, novel alternatives to home-stimulation devices for glaucoma patients considering treatment in 2024 include: 1) Percutaneous electrical nerve stimulation (PENS), which involves inserting needles into soft tissue and applying electrical stimulation, and 2) High-frequency spinal cord stimulation (SCS), which has shown efficacy in other neuropathic conditions and could be adapted for ocular nerve health. Both methods offer advanced electrical stimulation techniques that may provide benefits similar to home-stimulation devices.

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Device

Electrical Stimulation for Glaucoma (rtACS Trial)

N/A

Recruiting

Led By Jeffrey L Goldberg, MD PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through month 6

Awards & highlights

Summary

This trial is testing if using a home device that sends small electrical pulses to the eye can help treat open-angle glaucoma. It focuses on patients who are safe for this treatment but don't fit other trial criteria. The electrical pulses might help protect the eye nerves.

Who is the study for?

Adults with open-angle glaucoma, stable eye pressure, and specific visual field loss can join this trial. They must be able to follow the study plan and give informed consent. Excluded are those with certain eye conditions, seizures in the last 10 years, electronic implants like pacemakers, skin damage or acute diseases, pregnant or lactating women, recent vision study participants, uncontrolled hypertension or diabetes.

What is being tested?

The trial is testing a home device that provides long-term electrical stimulation (rtACS) to see if it's effective and safe for treating optic nerve damage caused by open-angle glaucoma.

What are the potential side effects?

Potential side effects of rtACS may include discomfort at the stimulation site or temporary visual disturbances. Since it involves electrical currents near the eyes, there might also be a risk of inducing seizures in susceptible individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in OCT angiography

Change from baseline in adaptive optics retinal imaging.

Change from baseline in laser speckle flowgraphy

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Active SASmExperimental Treatment1 Intervention

Patients will receive active treatment with the device every other day over 8 weeks.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent optic nerve damage. These include medications like prostaglandin analogs, which increase the outflow of aqueous humor, and beta-blockers, which reduce aqueous humor production. Electrical stimulation, as studied in the home-stimulation device trial, aims to promote nerve health or slow degeneration by potentially enhancing blood flow and neurotrophic support to the optic nerve. This is crucial for glaucoma patients as it offers a non-invasive method to protect the optic nerve, potentially preserving vision and slowing disease progression.

Find a Location

Who is running the clinical trial?

Otto-von-Guericke University MagdeburgOTHER

9 Previous Clinical Trials

2,684 Total Patients Enrolled

2 Trials studying Glaucoma

85 Patients Enrolled for Glaucoma

Stanford UniversityLead Sponsor

2,448 Previous Clinical Trials

17,492,374 Total Patients Enrolled

12 Trials studying Glaucoma

583 Patients Enrolled for Glaucoma

NYU Langone HealthOTHER

1,397 Previous Clinical Trials

861,822 Total Patients Enrolled

7 Trials studying Glaucoma

5,357 Patients Enrolled for Glaucoma

Media Library

Repetitive, Transorbital Alternating Current Stimulation (rtACS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05626426 — N/A

Glaucoma Research Study Groups: Active SASm

Glaucoma Clinical Trial 2023: Repetitive, Transorbital Alternating Current Stimulation (rtACS) Highlights & Side Effects. Trial Name: NCT05626426 — N/A

Repetitive, Transorbital Alternating Current Stimulation (rtACS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05626426 — N/A

~2 spots leftby Dec 2024

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