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Enrolling by Invitation

NCT Number: NCT06693882

Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.

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.

Enrolling by Invitation

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glaucoma Center of San Francisco

San Francisco, California, 94105, United States

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in visual field mean deviation (MD) from baseline to post-treatment

    Time frame: 12 months

    Visual field testing will be performed with the Humphrey field analyzer (Carl Zeiss Meditec)

Secondary outcomes

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

    Time frame: 12 months

    Optical coherence tomography (OCT) will be performed with the Cirrus OCT device (Carl Zeiss Meditec)

Sponsors and collaborators

Lead sponsor

Glaucoma Center of San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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