Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.

Part of paid clinical trials in San Francisco, California.

Sponsor
Glaucoma Center of San Francisco
Study ID
NCT06693882
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change in visual field mean deviation (MD) from baseline to post-treatment [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Glaucoma Center of San FranciscoSan FranciscoCalifornia94105-

Find similar trials in San Francisco, CA

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Glaucoma Center of San Francisco· San Francisco, CA

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