Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.

Glaucoma Center of San Francisco

Status: Invitation-only

Conditions: Glaucoma

Treatments: Device: EYETRONIC Nextwave System

Study type: Interventional

Funder types: Other

Identifiers

NCT06693882

Pro00080468

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Patients with glaucoma undergoing electrical stimulation of the optic nerve

Other group

Description:

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

Treatment:

Device: EYETRONIC Nextwave System