Electrical Stimulation for the Treatment of Glaucoma (rtACS)

January 31, 2024 updated by: Jeffrey L Goldberg, Stanford University

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Magdeburg, Germany
    • California
      • Palo Alto, California, United States, 94303
        • Recruiting
        • Byers Eye Institute
        • Contact:
    • New York
      • New York, New York, United States, 10017
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Wills Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant must be at least 18.
  2. Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
  3. 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%.
  4. Visual Field Index between 10 and 90%
  5. Corrected visual acuity ≥ 1.00 (logMAR), 20/200 (Snellen), 0.10 (decimal)
  6. In the opinion of the investigator the participant's eye pressure must be clinically stable.
  7. 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.
  8. 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.

Exclusion Criteria:

  1. Participant is unable to comply with study procedures or follow-up visits.
  2. Participant has a history of ocular herpes zoster.
  3. Participant has pathological nystagmus
  4. Participant has evidence of visually significant retinopathy including but not limited to Diabetic retinopathy or retinitis pigmentosa.
  5. Participant has evidence of corneal opacification or lack of optical clarity.
  6. Participant has uveitis or other ocular inflammatory disease.
  7. Participant has any electric or electronic implants such as a pacemaker.
  8. Participant has acute conjunctivitis.
  9. Participant has acute autoimmune disease.
  10. 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.
  11. Participant is pregnant or lactating.
  12. 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.
  13. Unresected brain tumors
  14. 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
  15. Patients with any skin damage.
  16. Children and comatose patients.
  17. Patients with history of epileptic seizure within the last 10 years.
  18. Patients with uncontrolled systemic hypertension or uncontrolled diabetes.
  19. Self-reported alcohol or illicit drug addictions within the last 12 months.
  20. 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
  21. Prior participation in a vision training/stimulation study in the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active SAVIR Alpha Synch Mobile device (SASm)
Patients will receive active treatment with the device every other day over 8 weeks.
Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina
Other Names:
  • Electrical Stimulation
Sham Comparator: Sham SAVIR Alpha Synch Mobile device (SASm)
Patients will receive sham treatment (no active stimulation) with the device every other day over 8 weeks.
Patients receive sham treatment (no active stimulation) every other day via a headband.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in visual field assessed by Humphrey Mean Deviation (MD).
Time Frame: Baseline through 6 months
Baseline through 6 months
Change from baseline in visual acuity as assessed by the Snellen visual acuity test.
Time Frame: Baseline through Month 6
The Snellen test is a standard eye chart test used to test eyesight.
Baseline through Month 6
Change from baseline in visual field assessed by Pelli-Robson Contrast Sensitivity.
Time Frame: Baseline through 6 months
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.
Baseline through 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 15, 2022

First Posted (Actual)

November 23, 2022

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 58329

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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