Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.

N/AEnrolling By InvitationNCT06693882

Glaucoma Center of San Francisco50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma

Interventions

EYETRONIC Nextwave SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 12 months

Secondary Outcomes

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)