Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2023-02-28
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active SAVIR Alpha Synch Mobile device (SASm)
Patients will receive active treatment with the device every other day over 8 weeks.
Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina
Sham SAVIR Alpha Synch Mobile device (SASm)
Patients will receive sham treatment (no active stimulation) with the device every other day over 8 weeks.
Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Patients receive sham treatment (no active stimulation) every other day via a headband.
Interventions
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Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina
Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS)
Patients receive sham treatment (no active stimulation) every other day via a headband.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Otto-von-Guericke University Magdeburg
OTHER
Wills Eye
OTHER
Stanford University
OTHER
Responsible Party
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Jeffrey L Goldberg
Professor of Ophthalmology
Principal Investigators
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Jeffrey L Goldberg, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Bernhard Sable, PhD
Role: PRINCIPAL_INVESTIGATOR
Otto-von-Guericke University Magdeburg
Joeseph F Panarelli, MD
Role: PRINCIPAL_INVESTIGATOR
NYU- Langone
Joel Schuman, MD,FACS
Role: PRINCIPAL_INVESTIGATOR
Wills Eye
Locations
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Byers Eye Institute
Palo Alto, California, United States
NYU- Langone
New York, New York, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Otto-von-Guericke University
Magdeburg, , Germany
Countries
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Facility Contacts
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Other Identifiers
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58329
Identifier Type: -
Identifier Source: org_study_id