[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633841":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":33,"centralContacts":38,"locations":45,"responsibleParty":108,"collaborators":110,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":134,"sex":140,"minAge":141,"maxAge":29,"enrollmentInfo":142,"targetDuration":29,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":61,"whyStopped":29,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Okuvision GmbH","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"TES-treatment with a rectangular stimulus","EXPERIMENTAL","A ramp is applied in the beginning of the stimulation to avoid that the patient is startled by the onset of stimulation: 0µA to therapy amplitude, ramping up in 30 seconds. The therapy amplitude is then maintained for 30 minutes. The stimulation parameters are: symmetric biphasic rectangular pulse (anodic at first) with a frequency of 20 Hz and a pulse duration of 10ms (5ms each phase). Stimulation will be performed once per week, for 30 minutes, for 12 months.",[13],"Device: Transcorneal electrical stimulation (TES) with the OkuStim 2 System",{"label":15,"type":10,"description":16,"interventionNames":17},"TES-treatment with a repetitive ramp stimulus","A ramp is applied in the beginning of the stimulation to avoid that the patient is startled by the onset of stimulation: 0µA to therapy amplitude, ramping up in 30 seconds. The therapy amplitude is then maintained for 30 minutes. The stimulation parameters are: ramp-down sawtooth current pulses (anodic first) with a frequency of 20 Hz. Stimulation will be performed once per week, for 30 minutes, for 12 months.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Sham group","SHAM_COMPARATOR","The stimulation in the sham-group will be carried out with 0µA. Sham-stimulation will be performed once per week, for 30 minutes, for 12 months",[13],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Transcorneal electrical stimulation (TES) with the OkuStim 2 System","In TES therapy with the OkuStim 2 System, retinal stimulation is achieved through transcorneal current application: using a thread electrode, the OkuEl M, a weak current (≤ 1mA) is introduced onto the surface of the eye, which spreads through the eye towards the retina.",[9,15],null,{"type":25,"name":26,"description":31,"armGroupLabels":32,"otherNames":29},"Sham-stimulation will be performed once per week, for 30 minutes, for 12 months without effective stimulation",[19],[34],{"name":35,"affiliation":36,"role":37},"Florian Gekeler, Prof. Dr.","Department of Ophthalmology, Klinikum Stuttgart, Germany","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Ruth Schippert, PhD","CONTACT","+49 7121 15935","55","studies@okuvision.de",[46,59,74,85,94],{"facility":47,"status":48,"city":49,"state":29,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":29},"Department of Ophthalmology, University Medical Center Hamburg-Eppendorf","NOT_YET_RECRUITING","Hamburg","20246","Germany","DE",{"type":54,"coordinates":55},"Point",[56,57],9.99302,53.55073,{"lat":57,"lon":56},{"facility":60,"status":61,"city":62,"state":29,"zip":63,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Department of Ophthalmology, Ludwig-Maximilians-University Munich","RECRUITING","München","80336",{"type":54,"coordinates":65},[66,67],13.31243,51.60698,{"lat":67,"lon":66},[70,72],{"name":29,"role":41,"phone":29,"phoneExt":29,"email":71},"augenklinik.studien@med.uni-muenchen.de",{"name":73,"role":37,"phone":29,"phoneExt":29,"email":29},"Claudia S. Priglinger, Prof. Dr.",{"facility":75,"status":61,"city":76,"state":29,"zip":77,"country":51,"countryCode":52,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Department of Ophthalmology, Klinikum Stuttgart","Stuttgart","70174",{"type":54,"coordinates":79},[80,81],9.17702,48.78232,{"lat":81,"lon":80},[84],{"name":35,"role":37,"phone":29,"phoneExt":29,"email":29},{"facility":86,"status":61,"city":87,"state":29,"zip":88,"country":51,"countryCode":52,"cosmosGeoPoint":89,"geoPoint":93,"contacts":29},"Centre for Ophthalmology, University Hospital Tuebingen","Tübingen","72076",{"type":54,"coordinates":90},[91,92],9.05222,48.52266,{"lat":92,"lon":91},{"facility":95,"status":48,"city":96,"state":29,"zip":97,"country":51,"countryCode":52,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Department of Ophthalmology, University Hospital Ulm","Ulm","89075",{"type":54,"coordinates":99},[100,101],9.99155,48.39841,{"lat":101,"lon":100},[104,106],{"name":29,"role":41,"phone":29,"phoneExt":29,"email":105},"studienzentrale.augenklinik@uniklinik-ulm.de",{"name":107,"role":37,"phone":29,"phoneExt":29,"email":29},"Armin Wolf, Prof. Dr.",{"type":109,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[111,114,116,118,120,121,123,126,128,130],{"name":112,"class":113},"CONVIDIA clinical research GmbH","UNKNOWN",{"name":115,"class":113},"Nubilaria Srl",{"name":117,"class":113},"TentaConsult Pharma & Med GmbH",{"name":119,"class":113},"Department of Ophthalmology, University Hospital Ulm, Germany",{"name":36,"class":113},{"name":122,"class":113},"Centre for Ophthalmology, University Hospital Tuebingen, Germany",{"name":124,"class":125},"Universitätsklinikum Hamburg-Eppendorf","OTHER",{"name":127,"class":113},"Department of Ophthalmology, Ludwig-Maximilians-University Munich, Germany",{"name":129,"class":113},"Steinbeis-Forschungszentrum, GRADE Reading Center",{"name":131,"class":113},"Clinical Study Core Unit SZB, Studienzentrum Bonn, University Hospital Bonn, Germany","100633841","safety-and-clinical-applicability-of-transcorneal-electrical-stimulation-tes-in-geographic-atrophy-100633841",false,"NCT07531927","Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy","Safety and Clinical Applicability of Transcorneal Electrical Stimulation (TES) in Geographic Atrophy Under Everyday Conditions - a Multicentric, Randomized, Double-masked, Sham-controlled Pilot Study","TES-GAP","Inclusion criteria:\n\n* Willing and able to understand the study and provide informed consent\n* 60 years of age or older\n* Diagnosis of geographic atrophy due to age-related macular degeneration confirmed by imaging\n* The affected area in the eye must be within a defined size range and clearly visible on imaging\n* Eye conditions must allow for good-quality images and reliable measurements\n* Must have a minimum level of visual acuity\n* Women of childbearing potential must have a negative pregnancy test, and must agree to use effective contraception during the study (women who are postmenopausal or surgically sterile are not subject to pregnancy-related requirements)\n\nExclusion criteria:\n\n* History or presence of certain eye conditions (e.g. macular edema, abnormal blood vessel growth or related conditions, retinal detachment, blood vessel blockage) in the study eye\n* Previous major eye surgeries (including retinal surgery or vitrectomy)\n* Previous laser treatment or injections in the study eye\n* Any other eye condition that could interfere with vision tests, imaging or study results\n* Planned eye surgery during the study period\n* Recent treatment with investigational drugs for geographic atrophy\n* Presence of active medical implants\n* Serious or uncontrolled systemic diseases, history of epilepsy or poor general health or conditions affecting the ability to follow study procedures\n* Participation in another clinical study recently or at the same time\n* Breastfeeding, relevant allergies (e.g. to silver), or heavy smoking","ALL","60 Years",{"count":143,"type":144},70,"ESTIMATED","INTERVENTIONAL",[147],"NA","Geographic atrophy (GA) is a progressive eye disease that causes the degeneration of the retinal cells, particularly in the macula, leading to vision loss. The goal of this pilot study is to evaluate the safety and the effectiveness of transcorneal electrical stimulation (TES) therapy with the OkuStim 2 System in patients with geographic atrophy (GA).\n\nResearchers will compare the effects of two different electrical stimuli with a placebo to see if the stimuli are safe and can slow down the progression of the disease.\n\nParticipants will be randomly assigned to one of these three groups:\n\n* TES-treatment with a rectangular stimulus\n* TES-treatment with a repetitive ramp stimulus\n* Placebo (sham) treatment\n\nParticipants will apply the therapy at home, once a week for 30 minutes each over a duration of 1 year.",[150],"Geographic Atrophy Secondary to Age-related Macular Degeneration",[152,153,154,155,156,157,158,159,160],"TES","TcES","OkuStim","OkuStim 2","Okuvision","Electrical Stimulation","Transcorneal Electrical Stimulation","Geographic Atrophy","AMD","2026-05-06",{"date":163,"type":164},"2026-05-07","ACTUAL",{"date":166,"type":164},"2026-05-05",{"date":168,"type":144},"2028-06",{"name":5,"class":6},5]