Glaucoma
Conditions
Brief summary
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.
Detailed description
1. During the study visits participants will have: general eye examination (visual acuity check, examination of the front and back of the eye, eye pressure measurement, pupil dilation), Visual field (VF) testing, Imaging the optic nerve with Optical Coherence Tomography (OCT), Optic nerve photos. 2. The treatment will include ten sessions during 2 weeks on an outpatient basis in a quiet and dimly lit room with the patient comfortably seated or lying down in a reclining chair. Each treatment session will last approximately 60 minutes including the time to determine the treatment settings.
Interventions
DEVICEEYETRONIC Nextwave System
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.
Sponsors
Glaucoma Center of San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective analysis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 18 years or older who have glaucoma * Humphrey visual field mean deviation (MD) values between - 6 dB and -20 dB
Exclusion criteria
* Age \< 18 years * Implanted electronic devices * Metallic artifacts in the head (except dentures) * Migraine * Epilepsy * Brain tumor * Pregnancy * Breastfeeding patients * Uncontrolled intraocular pressure (IOP) * IOP lowering medication started less than six months before enrollment * Any intraocular surgery less than 6 months before enrollment * Arterial hypertension without appropriate treatment * Acute retinal hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual field mean deviation (MD) from baseline to post-treatment | 12 months | Visual field testing will be performed with the Humphrey field analyzer (Carl Zeiss Meditec) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in retinal nerve fiber layer (RNFL) thickness from baseline to post-treatment | 12 months | Optical coherence tomography (OCT) will be performed with the Cirrus OCT device (Carl Zeiss Meditec) |
Countries
United States
Outcome results
None listed