Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.

Electrical Stimulation of the Optic Nerve in Patients With Glaucoma : Prospective Analysis of Perimetric Data up to 12 Months After Neuromodulatory Treatment.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Glaucoma
• Intervention / Treatment: Device: EYETRONIC Nextwave System

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94105
      • Glaucoma Center of San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patients with glaucoma undergoing electrical stimulation of the optic nerve; Single arm study of patients with glaucoma undergoing electrical stimulation of the optic nerve

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Glaucoma Center of San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: Pro00080468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No