Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.

NCT06693882 | Enrolling By Invitation

• 1 other identifier: Pro00080468
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in retinal nerve fiber layer (RNFL) thickness from baseline to post-treatment

  12 months

Study Arms (1)

Patients with glaucoma undergoing electrical stimulation of the optic nerve

OTHER

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

Device: EYETRONIC Nextwave System

Interventions

EYETRONIC Nextwave System 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.

Patients with glaucoma undergoing electrical stimulation of the optic nerve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 years or older who have glaucoma
• Humphrey visual field mean deviation (MD) values between - 6 dB and -20 dB

You may not qualify if:

• 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

Sponsors & Collaborators

• Glaucoma Center of San Francisco: lead

Study Sites (1)

Glaucoma Center of San Francisco

San Francisco, California, 94105, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective analysis

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)