Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.

NCT ID: NCT06693882

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with glaucoma undergoing electrical stimulation of the optic nerve

Single arm study of patients with glaucoma undergoing electrical stimulation of the optic nerve

Group Type: OTHER

EYETRONIC Nextwave System

Intervention Type: 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.

Interventions

EYETRONIC 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaucoma Center of San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Glaucoma Center of San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

Pro00080468

Identifier Type: -

Identifier Source: org_study_id