[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06693882":3,"trial-entities:NCT06693882":82,"trial-summary:NCT06693882":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":44,"minimum_age":45,"maximum_age":46,"healthy_volunteers":15,"eligibility_criteria":47,"std_ages":66,"locations":69,"central_contacts":78,"overall_officials":79,"references":80,"see_also_links":81},"NCT06693882","Pro00080468","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.","ENROLLING_BY_INVITATION","2025-12-31","2024-11","2024-11-20","2025-01-01","Glaucoma Center of San Francisco","OTHER",false,"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.\n\nThe main question it aims to answer is:\n\nCould this therapy be an option to counteract the loss of visual field seen in glaucoma and thus delay the progression of the disease?\n\nParticipants 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.","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.\n2. 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.",[19],"Glaucoma",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},50,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.\n\nEyetronic 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.",[34],"Patients with glaucoma undergoing electrical stimulation of the optic nerve",[36],{"measure":37,"description":38,"timeFrame":39},"Change in visual field mean deviation (MD) from baseline to post-treatment","Visual field testing will be performed with the Humphrey field analyzer (Carl Zeiss Meditec)","12 months",[41],{"measure":42,"description":43,"timeFrame":39},"Change in retinal nerve fiber layer (RNFL) thickness from baseline to post-treatment","Optical coherence tomography (OCT) will be performed with the Cirrus OCT device (Carl Zeiss Meditec)","ALL","18 Years",null,{"inclusion":48,"exclusion":51,"raw_text":65},[49,50],"Subjects 18 years or older who have glaucoma","Humphrey visual field mean deviation (MD) values between - 6 dB and -20 dB",[52,53,54,55,56,57,58,59,60,61,62,63,64],"Age \\\u003C 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","Inclusion Criteria:\n\n* Subjects 18 years or older who have glaucoma\n* Humphrey visual field mean deviation (MD) values between - 6 dB and -20 dB\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Implanted electronic devices\n* Metallic artifacts in the head (except dentures)\n* Migraine\n* Epilepsy\n* Brain tumor\n* Pregnancy\n* Breastfeeding patients\n* Uncontrolled intraocular pressure (IOP)\n* IOP lowering medication started less than six months before enrollment\n* Any intraocular surgery less than 6 months before enrollment\n* Arterial hypertension without appropriate treatment\n* Acute retinal hemorrhage",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":13,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"San Francisco","California","94105","United States",{"lat":76,"lon":77},37.77493,-122.41942,[],[],[],[],{"nct_id":4,"conditions":83,"biomarkers":84},[19],[],{"nct_id":4,"found":15,"summary":46,"prompt_version":46}]