NCT06693882

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.

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Glaucoma Center of San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-11-18
• Last updated: 2024-11-20

Locations

1 site across 1 country: United States