- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05626491
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
Status
Recruiting
Conditions
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
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-
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Magdeburg, Germany
- Recruiting
- Otto-von-Guericke University
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Contact:
- Study Team
- Phone Number: +49-391-672-1800
- Email: bernhard.sabel@med.ovgu.de
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-
-
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California
-
Palo Alto, California, United States, 94303
- Recruiting
- Byers Eye Institute
-
Contact:
- Study Team
- Phone Number: 650-497-5942
- Email: zacwenn@stanford.edu
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-
New York
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New York, New York, United States, 10017
- Recruiting
- NYU- Langone
-
Contact:
- Study Team
- Phone Number: 917-257-9091
- Email: angeles.ramos@nyulangone.org
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Wills Eye Hospital
-
Contact:
- Study Team
- Phone Number: 215-928-3163
- Email: tharwood@willseye.org
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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:
- 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.
Exclusion Criteria:
- 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.
- 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
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.
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Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina
Other Names:
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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.
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Patients receive sham treatment (no active stimulation) every other day via a headband.
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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
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Baseline through 6 months
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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
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Baseline through 6 months
|
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Change from baseline in visual acuity as assessed by the Snellen visual acuity test.
Time Frame: Baseline through Month 6
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The Snellen test is a standard eye chart test used to test eyesight.
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Baseline through Month 6
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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.
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Baseline through 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
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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