Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.

Not Applicable

• Conditions: Glaucoma

• Registration Number: NCT06693882
• Lead Sponsor: Glaucoma Center of San Francisco

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-18
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Study Start: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in visual field mean deviation (MD) from baseline to post-treatment	12 months	Visual field testing will be performed with the Humphrey field analyzer (Carl Zeiss Meditec)

Secondary Outcome Measures

Name	Time	Method
Change in retinal nerve fiber layer (RNFL) thickness from baseline to post-treatment	12 months	Optical coherence tomography (OCT) will be performed with the Cirrus OCT device (Carl Zeiss Meditec)

Trial Locations

Locations (1)

Glaucoma Center of San Francisco; 🇺🇸 San Francisco, California, United States