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The goal of this observational study is to evaluate electrical stimulation of the optic nerve with the Eyetronic Nextwave System device as a possible treatment for glaucoma.
The main question it aims to answer is:
Could this therapy be an option to counteract the loss of visual field seen in glaucoma and thus delay the progression of the disease?
Participants will have approximately 14-18 study visits during 12 months including 10 visits for the electrical stimulation treatment. The treatment involves electrically stimulating the optic nerve by an external approach via the facial skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with glaucoma undergoing electrical stimulation of the optic nerve | Other | Single arm study of patients with glaucoma undergoing electrical stimulation of the optic nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EYETRONIC Nextwave System | Device | Eyetronic Nextwave is a neurostimulation device that stimulates the optic nerve non-invasively using transcranial alternating current stimulation delivered through goggles in patients presenting with glaucoma. Eyetronic is approved in Europe for the treatment of glaucoma to possibly delay progression of visual field (VF) loss for at least 12 months. The indication for use in Europe includes all patients suffering from neuropathies of the optic nerve resulting in loss of VF. Two studies conducted in Europe have demonstrated improvement in visual fields following 10-days of optic nerve stimulation treatment with this device. In the current study, the Eyetronic system will be used to treat only those individuals who have visual field loss from glaucoma. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual field mean deviation (MD) from baseline to post-treatment | Visual field testing will be performed with the Humphrey field analyzer (Carl Zeiss Meditec) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in retinal nerve fiber layer (RNFL) thickness from baseline to post-treatment | Optical coherence tomography (OCT) will be performed with the Cirrus OCT device (Carl Zeiss Meditec) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaucoma Center of San Francisco | San Francisco | California | 94105 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Prospective analysis
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