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.
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
- Are there results?
- Not yet: the study is under way
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.
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
About this study
Official title: Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Glaucoma
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health, Otto-von-Guericke University Magdeburg, Wills Eye
- Responsible party
- Principal investigator, Jeffrey L Goldberg, Stanford University
- Investigators
- Jeffrey L Goldberg, MD PhD, Principal investigator, Stanford UniversityBernhard Sable, PhD, Principal investigator, Otto-von-Guericke University MagdeburgJoeseph F Panarelli, MD, Principal investigator, NYU- LangoneJoel Schuman, MD,FACS, Principal investigator, Wills Eye
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Glaucoma
- ClinicalTrials.gov ID
- NCT05626491
- Acronym / sponsor ID
- rtACS / 58329
- Conditions
- Glaucoma, Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- NYU Langone Health, Otto-von-Guericke University Magdeburg, Wills Eye
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active SAVIR Alpha Synch Mobile device (SASm) | Experimental | Device: Repetitive, Transorbital Alternating Current Stimulation (rtACS)Patients will receive active treatment with the device every other day over 8 weeks. |
| Sham SAVIR Alpha Synch Mobile device (SASm) | Sham comparator | Device: Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)Patients will receive sham treatment (no active stimulation) with the device every other day over 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive, Transorbital Alternating Current Stimulation (rtACS)Also: Electrical StimulationPatients receive treatment every other day via a headband that delivers electrical stimulation to the retina | Device | Active SAVIR Alpha Synch Mobile device (SASm) |
| Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)Patients receive sham treatment (no active stimulation) every other day via a headband. | Device | Sham SAVIR Alpha Synch Mobile device (SASm) |
Primary outcome
Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).
Time frame: Baseline through 6 months
3 secondary outcomes
Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).
Time frame: Baseline through 6 months
Change from baseline in visual field assessed by Pelli-Robson Contrast Sensitivity.
Time frame: Baseline through 6 months
Change from baseline in visual acuity as assessed by the Snellen visual acuity test.
Time frame: Baseline through Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey L Goldberg, MD PhD principal investigator
Stanford University
Bernhard Sable, PhD principal investigator
Otto-von-Guericke University Magdeburg
Joeseph F Panarelli, MD principal investigator
NYU- Langone
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI). (time frame: Baseline through 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.