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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
| Otto-von-Guericke University Magdeburg | OTHER |
| Wills Eye | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active SAVIR Alpha Synch Mobile device (SASm) | Experimental | Patients will receive active treatment with the device every other day over 8 weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive, Transorbital Alternating Current Stimulation (rtACS) | Device | Patients receive treatment every other day via a headband that delivers electrical stimulation to the retina |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in visual field assessed by Humphrey Visual Field Index (VFI). | Baseline through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute | Palo Alto | California | 94303 | United States | ||
| NYU- Langone |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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| Sham Repetitive, Transorbital Alternating Current Stimulation (rtACS) | Device | Patients receive sham treatment (no active stimulation) every other day via a headband. |
|
| Baseline through 6 months |
| Change from baseline in visual acuity as assessed by the Snellen visual acuity test. | The Snellen test is a standard eye chart test used to test eyesight. | Baseline through Month 6 |
| New York |
| New York |
| 10017 |
| United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Otto-von-Guericke University | Magdeburg | Germany |