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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.
This is a concurrent open-label study for patients who are deemed safe to participate in the electrical stimulation trial but do not fit the exact criteria for the randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active SASm | Experimental | Patients will receive active treatment 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 | |
| Change from baseline in visual field assessed by Humphrey Mean Deviation (MD). | Baseline through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ganglion cell layer as measured by optical coherence tomography (OCT, visible light and/or infrared). | Baseline through 6 months | |
| Change from baseline in nerve fiber layer thickness as measured by optical coherence tomography (OCT, visible light and/or infrared). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Goldberg, MD PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute | Recruiting | Palo Alto | California | 94303 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D009901 | Optic Nerve Diseases |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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|
| 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 |
| Change from baseline in visual evoked potential. | Baseline through Month 6 |
| Change from baseline in retinal metabolic analysis(RMA)/OcuMet imaging. | There are two index measures of retinal metabolism and a normative database; change from baseline with a statistically significant difference from test-retest variability will be the exploratory endpoint measured here. | Baseline through Month 6 |
| Change from baseline in adaptive optics retinal imaging. | There are no index measures for adaptive optics retinal imaging in this disease; change from baseline will be the exploratory endpoint measured here. | Baseline through Month 6 |
| Change from baseline in laser speckle flowgraphy | There is one index measure of retinal blood flow response to light stimulation; change from baseline with a statistically significant difference from test-retest variability will be the exploratory endpoint measured here. | Baseline through Month 6 |
| Change from baseline in OCT angiography | There are 3 index measures of retinal blood flow in OCT-A; change from baseline with a statistically significant difference from test-retest variability will be the exploratory endpoint measured here. | Baseline through Month 6 |