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| Name | Class |
|---|---|
| EYETRONIC, Inc | UNKNOWN |
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The purpose of the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rtACS treatment | Experimental | Participants will receive 10 days of rtACS treatment in office. |
|
| Sham | Placebo Comparator | Participants will be wearing device but no stimulation will occur for 10 treatments in office. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eyetronic rtACS | Device | The repetitive, transorbital alternating current stimulation (rtACS) is a device for non-invasive Interventional Neurophysiology. The electrical charge and current density applied during rtACS safe and able to modulate existing neuronal elements in the eye and brain. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Field Index (VFI) | Measuring the change in the Visual Field Index (VFI) from baseline to month 3. | 3 Months |
| Mean Deviation (MD) | Measuring the change in Mean Deviation on Visual Field from Baseline to Month 3. | 3 Months |
| Pointwise Linear Regression (PLR) | Measuring the PLR of the visual field points from baseline to Month 3. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Ganglion Cell Layer | The change in ganglion cell layer as measured by optical coherence tomography (OCT) through 3 months | 3 Months |
| Retinal Nerve Fiber Layer | The change in nerve fiber layer thickness as measured by OCT through 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Contact | 650-497-5942 | glaucomatrials@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Goldberg, MD PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Recruiting | Palo Alto | California | 94303 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Sham rtACS | Device | Participants will wear the Eyetronic system but there will be no active stimulations applied. |
|
| 3 Months |
| Best Corrected Visual Acuity | The change in best corrected visual acuity (BCVA) through 3 months | 3 Months |
| Stead-State Visually Evoked Potential | The change in visual evoked potential (VEP) through 3 months | 3 Months |
| OCT-Angiography | The change in OCT angiography (OCT-A) through 3 months | 3 Months |
| Retinal Metabolic Analysis | The change in retinal metabolic analysis (RMA)/OcuMet imaging through 3 months | 3 Months |
| Visual Field indicies in Non-Study Eye | Change in visual field indices in non-study eye through 3 months. | 3 Months |