Electrical Stimulation of the Optic Nerve in Patients With Glaucoma.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EYETRONIC Nextwave System.
- Who it may be relevant to
- Registry conditions: Glaucoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Electrical Stimulation of the Optic Nerve in Patients With Glaucoma : Prospective Analysis of Perimetric Data up to 12 Months After Neuromodulatory Treatment.
Overview
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.
Interventions
- 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 conducte
Primary outcome measures
- Change in visual field mean deviation (MD) from baseline to post-treatment [Time frame: 12 months]
Secondary outcome measures (1)
- Change in retinal nerve fiber layer (RNFL) thickness from baseline to post-treatment [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Glaucoma Center of San Francisco — San Francisco
Identifiers
NCT: NCT06693882 · Pro00080468