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Electrical Stimulation for the Treatment of Glaucoma (rtACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05626491
Recruitment Status : Recruiting
First Posted : November 23, 2022
Last Update Posted : February 2, 2024
Sponsor:
Collaborators:
NYU Langone Health
Otto-von-Guericke University Magdeburg
Wills Eye
Information provided by (Responsible Party):
Jeffrey L Goldberg, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glaucoma Glaucoma, Open-Angle Device: Repetitive, Transorbital Alternating Current Stimulation (rtACS) Device: Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluate the Safety and Efficacy of Repetitive, Transorbital Alternating Current Stimulation (rtACS) for the Treatment of Glaucoma
Actual Study Start Date : February 28, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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.
 Device: Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina
Other Name: 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.
 Device: Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Patients receive sham treatment (no active stimulation) every other day via a headband.


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

Secondary Outcome Measures :
  1. Change from baseline in visual field assessed by Humphrey Mean Deviation (MD). [ Time Frame: Baseline through 6 months ]
  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05626491


Locations
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United States, California
Byers Eye Institute Recruiting
Palo Alto, California, United States, 94303
Contact: Study Team    650-497-5942    zacwenn@stanford.edu   
United States, New York
NYU- Langone Recruiting
New York, New York, United States, 10017
Contact: Study Team    917-257-9091    angeles.ramos@nyulangone.org   
United States, Pennsylvania
Wills Eye Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Study Team    215-928-3163    tharwood@willseye.org   
Germany
Otto-von-Guericke University Recruiting
Magdeburg, Germany
Contact: Study Team    +49-391-672-1800    bernhard.sabel@med.ovgu.de   
Sponsors and Collaborators
Stanford University
NYU Langone Health
Otto-von-Guericke University Magdeburg
Wills Eye
Investigators
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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
More Information
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Responsible Party: Jeffrey L Goldberg, Professor of Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT05626491    
Other Study ID Numbers: 58329
First Posted: November 23, 2022    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases