GlaucomartACSNCT05626491

Electrical Stimulation for the Treatment of Glaucoma

A study testing Repetitive, Transorbital Alternating Current Stimulation (rtACS) in people with Glaucoma and Glaucoma, Open-Angle, run by Stanford University at 4 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The overall aim of this study is to see whether long-term electrical stimulation with a home-stimulation device works well and is safe for the treatment of open-angle glaucoma. Open-Angle Glaucoma is a disease where the nerves in the back of your eye die off faster than expected regardless of your eye pressure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Glaucoma, Open-Angle
What is being tested?: Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 4 sitesin 2 countries
Study dates: 28 Feb 2023to Jun 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant must be at least 18.
Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
Participant's clinical diagnosis must be consistent with glaucoma characterized by the following features: Mean deviation (MD) worse than -3 on Humphrey Visual Field 24-2 testing. Reliable visual field measures, fixation losses do not exceed 20% and false positives do not exceed 20%.
Visual Field Index between 10 and 90%
Corrected visual acuity ≥ 1.00 (logMAR), 20/200 (Snellen), 0.10 (decimal)
In the opinion of the investigator the participant's eye pressure must be clinically stable.
If a participant has two eyes meeting study criteria, the worse eye as determined by mean deviation. If both eyes qualify and have the same MD, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study.
Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.

Who cannot join

Participant is unable to comply with study procedures or follow-up visits.
Participant has a history of ocular herpes zoster.
Participant has pathological nystagmus
Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa.
Participant has evidence of corneal opacification or lack of optical clarity.
Participant has uveitis or other ocular inflammatory disease.

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Participant has any electric or electronic implants such as a pacemaker.
Participant has acute conjunctivitis.
Participant has acute autoimmune disease.
Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
Participant is pregnant or lactating.
Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments. Including but not limited to all forms of dementia.
Unresected brain tumors
Implanted intracranial magnetic metals (metallic implants in the head / skull such as clamps, coils, ventriculo-peritoneal shunts, endoprostheses, etc.), which are not MRI-compatible. Note: metallic dental implants and titanium screws or plates are acceptable
Patients with any skin damage.
Children and comatose patients.
Patients with history of epileptic seizure within the last 10 years.
Patients with uncontrolled systemic hypertension or uncontrolled diabetes.
Self-reported alcohol or illicit drug addictions within the last 12 months.
Participant is not able to travel, to comply with the requirements of the study or not willing to complete the schedule of events (SOE) and/or unable to confirm follow-up participation
Prior participation in a vision training/stimulation study in the last 12 months

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States3 sites

NYU- Langone
New York, New York, 10017
Byers Eye Institute
Palo Alto, California, 94303
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107

Other trials in United States

Germany1 site

Otto-von-Guericke University
Magdeburg

Other trials in Germany

About this study

Official title: Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Glaucoma

Conditions: Glaucoma, Glaucoma, Open-Angle
Being tested: Repetitive, Transorbital Alternating Current Stimulation (rtACS), Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Medical subject headings: Glaucoma, Glaucoma, Open-Angle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Repetitive, Transorbital Alternating Current Stimulation (rtACS)Device
Also called Electrical Stimulation
Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina
Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)Device
Patients receive sham treatment (no active stimulation) every other day via a headband.

Study groups in NCT05626491
Study group	Role	What they receive
Active SAVIR Alpha Synch Mobile device (SASm)	Experimental	Patients will receive active treatment with the device every other day over 8 weeks. Receives: Device: Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Sham SAVIR Alpha Synch Mobile device (SASm)	Sham comparator	Patients will receive sham treatment (no active stimulation) with the device every other day over 8 weeks. Receives: Device: Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).
Measured: Baseline through 6 months

Secondary outcomes (3)

Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).
Measured: Baseline through 6 months
Change from baseline in visual field assessed by Pelli-Robson Contrast Sensitivity.
Pelli-Robson is a standard for measuring contrast sensitivity. It is measured on a 0-16 scale. Normal contrast sensitivity is between 12 and 14 with 0 being worst and 16 being best.
Measured: Baseline through 6 months
Change from baseline in visual acuity as assessed by the Snellen visual acuity test.
The Snellen test is a standard eye chart test used to test eyesight.
Measured: Baseline through Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 2023Jun 2027

First posted23 Nov 2022
Study start28 Feb 2023
Primary completionDec 2026 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 45 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05626491
Sponsor's protocol ID: 58329
Acronym: rtACS
Status last verified: Oct 2026
First submitted: 15 Nov 2022
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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