Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT01835002
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2013-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcorneal Electrical Stimulation - Multicenter Safety Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012174', 'term': 'Retinitis Pigmentosa'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2013-04-15', 'studyFirstSubmitQcDate': '2013-04-17', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ophthalmic examinations', 'timeFrame': '6 months', 'description': 'visual acuity slit lamp microscopy for examination of the anterior and posterior segment intraocular pressure measurement visual field examination Optical coherence tomography (OCT) Digital colour fundus photography'}], 'secondaryOutcomes': [{'measure': 'Questionnaires', 'timeFrame': '6 months', 'description': "Questionnaires to collect the patient's perceived benefits of treatment and handling of the device"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['transcorneal electrostimulation'], 'conditions': ['Retinitis Pigmentosa']}, 'referencesModule': {'references': [{'pmid': '23049087', 'type': 'BACKGROUND', 'citation': 'Naycheva L, Schatz A, Rock T, Willmann G, Messias A, Bartz-Schmidt KU, Zrenner E, Gekeler F. Phosphene thresholds elicited by transcorneal electrical stimulation in healthy subjects and patients with retinal diseases. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7440-8. doi: 10.1167/iovs.12-9612.'}, {'pmid': '22350549', 'type': 'BACKGROUND', 'citation': 'Gekeler F; Arbeitsgruppe Elektrostimulation des Department fur Augenheilkunde am Universitats-Klinikum Tubingen. [Transcorneal electrostimulation]. Ophthalmologe. 2012 Feb;109(2):129-35. doi: 10.1007/s00347-011-2450-6. German.'}, {'pmid': '21467183', 'type': 'BACKGROUND', 'citation': 'Schatz A, Rock T, Naycheva L, Willmann G, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Messias A, Gekeler F. Transcorneal electrical stimulation for patients with retinitis pigmentosa: a prospective, randomized, sham-controlled exploratory study. Invest Ophthalmol Vis Sci. 2011 Jun 23;52(7):4485-96. doi: 10.1167/iovs.10-6932.'}, {'pmid': '22807300', 'type': 'BACKGROUND', 'citation': 'Schatz A, Arango-Gonzalez B, Fischer D, Enderle H, Bolz S, Rock T, Naycheva L, Grimm C, Messias A, Zrenner E, Bartz-Schmidt KU, Willmann G, Gekeler F. Transcorneal electrical stimulation shows neuroprotective effects in retinas of light-exposed rats. Invest Ophthalmol Vis Sci. 2012 Aug 15;53(9):5552-61. doi: 10.1167/iovs.12-10037.'}, {'pmid': '23329121', 'type': 'BACKGROUND', 'citation': "Rock T, Schatz A, Naycheva L, Gosheva M, Pach J, Wilhelm B, Peters T, Bartz-Schmidt KU, Zrenner E, Willmann G, Gekeler F. [Effects of transcorneal electrical stimulation in patients with Stargardt's disease]. Ophthalmologe. 2013 Jan;110(1):68-73. doi: 10.1007/s00347-012-2749-y. German."}, {'pmid': '31775146', 'type': 'RESULT', 'citation': 'Jolly JK, Wagner SK, Martus P, MacLaren RE, Wilhelm B, Webster AR, Downes SM, Charbel Issa P, Kellner U, Jagle H, Ruther K, Bertelsen M, Bragadottir R, Prener Holtan J, van den Born LI, Sodi A, Virgili G, Gosheva M, Pach J, Zundorf I, Zrenner E, Gekeler F. Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa: A Multicenter Safety Study of the OkuStim(R) System (TESOLA-Study). Ophthalmic Res. 2020;63(3):234-243. doi: 10.1159/000505001. Epub 2019 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.', 'detailedDescription': 'This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist\n* adult patients who are capable of giving consent,\n* Visual acuity ≥ 0.02\n* because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)\n* the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol\n\nExclusion Criteria:\n\n* diabetic retinopathy\n* neovascularisation of any origin\n* after arterial or venous occlusion\n* after retinal detachment\n* silicone oil tamponade\n* dry or exudative age-related macular degeneration\n* macular edema\n* all forms of glaucoma\n* any form of corneal degeneration that reduces visual acuity\n* systemic diseases that are difficult to control or manage, that could endanger the normal study schedule\n* patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic\n* forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia\n* simultaneous participation in another interventional study or history of interventions whose effect may still persist'}, 'identificationModule': {'nctId': 'NCT01835002', 'briefTitle': 'Transcorneal Electrical Stimulation - Multicenter Safety Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Okuvision GmbH'}, 'officialTitle': 'Transcorneal Electrical Stimulation for the Treatment of Retinitis Pigmentosa - a Multicenter Safety Study of the Okustim ® System', 'orgStudyIdInfo': {'id': 'TESOLA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OkuStim', 'description': 'Electrostimulation Standard Treatment with OkuStim', 'interventionNames': ['Device: Transcorneal electrostimulation']}], 'interventions': [{'name': 'Transcorneal electrostimulation', 'type': 'DEVICE', 'otherNames': ['OkuStim', 'TES', 'TcES'], 'description': 'Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.', 'armGroupLabels': ['OkuStim']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Glostrup Hospital and Kennedy Center', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'University Eye Clinic Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Augenzentrum München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'University Eye Clinic Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '53721', 'city': 'Siegburg', 'country': 'Germany', 'facility': 'Zentrum für seltene Netzhauterkrankungen, AugenZentrum Siegburg', 'geoPoint': {'lat': 50.80019, 'lon': 7.20769}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Centre for Ophthalmology at the eye clinic Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Florian Gekeler, Prof Dr med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eberhard-Karls-Universität Tübingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okuvision GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}