Active not recruitingNAINTERVENTIONAL

Electrical Stimulation for the Treatment of Glaucoma

This research study is investigating a new way to treat open-angle glaucoma, a common eye condition where the nerve connecting your eye to your brain (called the optic nerve) gets damaged, often leading to vision loss. Even if your eye pressure is normal, these nerves can still deteriorate faster than they should. In this study, we're using a small device that delivers gentle electrical stimulation to the eye. We want to find out if using this device at home over a longer period can help improve or stabilize vision, and importantly, if it is safe for people with open-angle glaucoma. This could potentially offer a new treatment option in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

Stanford University

Enrolment target

Start

28 Feb 2023

Estimated completion

01 Dec 2026

Glaucoma Glaucoma, Open-Angle

What is this study about?

You're reading about a research study looking into a condition called open-angle glaucoma. This is a common eye problem where the nerve that sends messages from your eye to your brain starts to die off. This can happen even if the pressure inside your eye is normal. Over time, this damage can lead to problems with your eyesight. Think of it like a cable that carries important information; if parts of the cable are damaged, the messages don't get through as well.

Doctors are exploring a new approach using a small device that gives out very mild electrical pulses to the area around your eye. This is called 'transorbital alternating current stimulation' or 'rtACS' for short. The main aim of this study is to see if using this device at home for a longer period of time can help people with open-angle glaucoma. They want to find out if it's both safe to use and if it actually helps to protect or improve vision.

Another important part of this study is that some people will receive the real electrical stimulation, while others will receive a 'sham' treatment. The sham treatment is like a dummy treatment that feels similar but doesn't deliver the actual electrical pulses. This is a common way to test new treatments, as it helps researchers figure out if any improvements are due to the device itself or simply other factors. By doing this, they can get a clearer picture of whether the electrical stimulation genuinely works.

Key takeaways

The study tests a new home electrical device for open-angle glaucoma.
It aims to find out if the device is safe and effective for long-term use.
Some participants will get real stimulation, others a dummy (sham) treatment.
You must have diagnosed open-angle glaucoma with stable eye pressure.
Certain other eye conditions or implanted electronic devices exclude participation.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and able to follow all the study instructions and attend appointments. You must have a clear diagnosis of glaucoma, specifically open-angle glaucoma, where certain tests show your vision has been affected. Your current eye pressure needs to be stable and well-managed, according to your doctor. Importantly, your vision should be within a specific range, and if you have two eyes that meet the criteria, the research team will decide which eye will be part of the study.

There are also some reasons why you might not be able to join. For example, if you have certain other eye conditions like a history of shingles in your eye, specific types of eye inflammation, or other serious eye diseases like diabetic retinopathy. If you have any electrical or electronic devices implanted in your body, like a pacemaker, you also won't be able to take part due to the electrical stimulation involved. Additionally, if you're currently in another drug trial or have been very recently, you might not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Do you have a confirmed diagnosis of open-angle glaucoma?
Do you have stable eye pressure, as confirmed by your doctor?
Do you NOT have an implanted electrical device (like a pacemaker)?
Have you NOT had shingles in your eye or other certain severe eye inflammations?
Can you attend regular clinic visits and use a home device as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in the study for a period of time, though the exact total duration isn't specified here. During this time, you'll need to use a special electrical stimulation device at home. You'll also have a number of visits to the study clinic for check-ups and to complete various assessments. These assessments will likely include detailed eye examinations, vision tests, and possibly other tests to monitor the health of your eyes and track any changes in your glaucoma. You won't be given any new medication for glaucoma as part of this study, as it's focused on the electrical stimulation device. You'll continue to see your regular doctors for your usual glaucoma care. You will be fully informed about the schedule of these visits and what each will involve before you agree to participate.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is that the electrical stimulation *might* help to slow down the progression of your glaucoma or even improve some aspects of your vision, though this is not guaranteed as it's still being investigated. The main risks could include mild discomfort or irritation from the device, and there's also the chance it might not be effective for you. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Byers Eye Institute
Verified postcode
Palo Alto, United States
NYU- Langone
Verified postcode
New York, United States
Wills Eye Hospital
Verified postcode
Philadelphia, United States
Otto-von-Guericke University
Verified postcode
Magdeburg, Germany

Common questions

What is open-angle glaucoma?

It's an eye condition where the nerve connecting your eye to your brain gets damaged, often leading to vision loss, even if your eye pressure is normal.

What is the 'electrical stimulation'?

It's a gentle electrical pulse delivered to the area around your eye using a special device, which researchers are testing to see if it helps glaucoma.

Will I know if I'm getting the real treatment?

No, you won't know because some people get the active treatment and others get a 'sham' (dummy) treatment. This helps researchers fairly assess the device's effects.

Do I need to stop my current glaucoma medicine?

No, this study doesn't involve stopping your current glaucoma medication. You will continue with your usual prescribed treatments.

How long will I be in the study?

The information provided doesn't state the exact total duration, but you'll be using a home device long-term and attending regular clinic visits.