What side effects are associated with this type of intervention?

Common treatments for Open-Angle Glaucoma include medications, laser therapy, and surgical procedures. 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 inflammation or increased eye 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, side effects are generally mild and may include sensations like warmth, tingling, or muscle spasms, with no serious adverse events reported.

What prior FDA approvals exist?

FDA-approved treatments for Open-Angle Glaucoma primarily include medications such as prostaglandin analogs, beta-blockers, alpha agonists, carbonic anhydrase inhibitors, and Rho kinase inhibitors, which aim to reduce intraocular pressure. Surgical options like trabeculectomy and laser therapies are also approved. While the context mentions ongoing research into long-term electrical stimulation for nerve health in Open-Angle Glaucoma, there are no specific FDA approvals for such devices yet. This area remains under investigation to determine its efficacy and safety.

What other types of research exist?

Promising novel alternatives to home-stimulation devices for open-angle glaucoma patients include optogenetic transducer devices and ultrasonic retinal neuromodulation. These technologies offer potential for non-invasive neural modulation and vision restoration.

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Electrical Stimulation

Electrical Stimulation for Glaucoma (rtACS Trial)

N/A

Recruiting

Led By Joel Schuman, MD

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

Summary

This trial is testing if using a home device that sends small electrical pulses to the eyes can help treat open-angle glaucoma. This condition causes eye nerves to die off quickly, and the study aims to see if this new method is safe and effective.

Who is the study for?

Adults with open-angle glaucoma, stable eye pressure, and certain visual field measures can join. They must be able to follow the study plan and give informed consent. Excluded are those with significant retinopathy, unclear corneas, autoimmune diseases, recent participation in other drug trials for the eyes or systemically, pregnancy or lactation, mental conditions affecting study compliance or safety concerns like implanted non-MRI-compatible metals.

What is being tested?

The trial is testing a home device that provides electrical stimulation to the eye (rtACS) against a sham treatment to see if it's effective and safe for treating open-angle glaucoma over the long term. Participants will randomly receive either real rtACS or a fake version without actual stimulation.

What are the potential side effects?

Potential side effects may include discomfort at the site of stimulation, headache, dizziness or temporary vision changes due to electrical current application. The risk of more serious side effects is not specified but would be monitored throughout the trial.

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 visual acuity as assessed by the Snellen visual acuity test.

Change from baseline in visual field assessed by Pelli-Robson Contrast Sensitivity.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active SAVIR Alpha Synch Mobile device (SASm)Experimental Treatment1 Intervention

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

Group II: Sham SAVIR Alpha Synch Mobile device (SASm)Placebo Group1 Intervention

Patients will receive sham treatment (no active stimulation) 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

The most common treatments for Open-Angle Glaucoma aim to reduce intraocular pressure (IOP) to prevent further optic nerve damage. Medications such as prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors work by either decreasing the production of aqueous humor or increasing its outflow. Surgical options, including trabeculectomy and laser therapy, also focus on enhancing fluid drainage from the eye. Electrical stimulation, as studied in the Home-Stimulation Device trial, offers a novel approach by potentially promoting nerve health and slowing degeneration, which is crucial for preserving vision in glaucoma patients. This method may complement traditional treatments by directly targeting the optic nerve's resilience against damage.