NCT05626491

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Feb 2023Dec 2026

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

November 15, 2022

Last Update Submit

April 22, 2026

Conditions

GlaucomaGlaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI).

    Baseline through 6 months

Secondary Outcomes (3)

  • Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).

    Baseline through 6 months

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

    Baseline through 6 months

  • Change from baseline in visual acuity as assessed by the Snellen visual acuity test.

    Baseline through Month 6

Study Arms (2)

Active SAVIR Alpha Synch Mobile device (SASm)

EXPERIMENTAL

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

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.

Device: Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)

Interventions

Repetitive, Transorbital Alternating Current Stimulation (rtACS)DEVICE

Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina

Also known as: Electrical Stimulation
Active SAVIR Alpha Synch Mobile device (SASm)
Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)DEVICE

Patients receive sham treatment (no active stimulation) every other day via a headband.

Sham SAVIR Alpha Synch Mobile device (SASm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Byers Eye Institute

Palo Alto, California, 94303, United States

Location

NYU- Langone

New York, New York, 10017, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Otto-von-Guericke University

Magdeburg, Germany

Location

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Jeffrey L Goldberg, MD PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Bernhard Sable, PhD

    Otto-von-Guericke University Magdeburg

    PRINCIPAL INVESTIGATOR

  • Joeseph F Panarelli, MD

    NYU- Langone

    PRINCIPAL INVESTIGATOR

  • Joel Schuman, MD,FACS

    Wills Eye

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

February 28, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)DE(1)