Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT00804102
Status:
COMPLETED
Last Update Posted:
2012-05-04
First Post:
2008-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcorneal Electrical Stimulation Therapy for Retinal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-12-30', 'releaseDate': '2013-11-08'}, {'resetDate': '2015-11-12', 'releaseDate': '2015-10-14'}], 'estimatedResultsFirstSubmitDate': '2013-11-08'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012174', 'term': 'Retinitis Pigmentosa'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D015356', 'term': 'Retinal Artery Occlusion'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D029241', 'term': 'Optic Atrophy, Autosomal Dominant'}], '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'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D015418', 'term': 'Optic Atrophies, Hereditary'}, {'id': 'D009896', 'term': 'Optic Atrophy'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D028361', 'term': 'Mitochondrial Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-03', 'studyFirstSubmitDate': '2008-12-05', 'studyFirstSubmitQcDate': '2008-12-05', 'lastUpdatePostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'enhanced field of vision, enhanced visual acuity, lower threshold for electrical evoked phosphenes', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Retinitis pigmentosa', 'Macula off', 'Primary open angle Glaucoma', 'Hereditary Macular Degeneration', 'Treated Retina detachment', 'Retinal Artery Occlusion', 'Retinal Vein Occlusion,', 'Non-Arthritic-Anterior-Ischemic Optic-Neuropathy', 'Hereditary autosomal dominant Optic atrophy', 'dry Age-related Macular Degeneration', 'Ischemic Macula edema'], 'conditions': ['Retinitis Pigmentosa', 'Macula Off', 'Primary Open Angle Glaucoma', 'Hereditary Macular Degeneration', 'Treated Retina Detachment', 'Retinal Artery Occlusion', 'Retinal Vein Occlusion', 'Non-Arthritic-Anterior-Ischemic Optic-Neuropathy', 'Hereditary Autosomal Dominant Optic Atrophy', 'Dry Age Related Macular Degeneration', 'Ischemic Macula Edema']}, 'referencesModule': {'references': [{'pmid': '21467183', 'type': 'RESULT', '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': '23049087', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema\n\nExclusion Criteria:\n\n* Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration\n* Age above 99 years'}, 'identificationModule': {'nctId': 'NCT00804102', 'briefTitle': 'Transcorneal Electrical Stimulation Therapy for Retinal Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Okuvision GmbH'}, 'officialTitle': 'Transcorneal Electrical Stimulation Therapy for Retinal Disease - A Randomized, Single-blind Pilot Study', 'orgStudyIdInfo': {'id': 'EST-2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Retinitis pigmentosa', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Macula off', 'description': 'condition after treatment of retinal detachment', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Primary open angle Glaucoma', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hereditary Macular Degeneration', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treated Retina detachment', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Retinal Artery Occlusion', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Retinal Vein Occlusion', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hereditary autosomal dominant Optic atrophy', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dry Age-related Macular Degeneration', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ischemic Macula edema', 'interventionNames': ['Device: Transcorneal Electrical Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Non-stimulated', 'interventionNames': ['Device: DTL-electrode attached without energy']}], 'interventions': [{'name': 'Transcorneal Electrical Stimulation', 'type': 'DEVICE', 'description': 'Neurostimulator drives Dawson-Trick-Litzkow electrode attached to patient eye. Different modi are used to stimulate patients.', 'armGroupLabels': ['Hereditary Macular Degeneration', 'Hereditary autosomal dominant Optic atrophy', 'Ischemic Macula edema', 'Macula off', 'Non-Arteriitic-Anterior-Ischemic Optic-Neuropathy', 'Primary open angle Glaucoma', 'Retinal Artery Occlusion', 'Retinal Vein Occlusion', 'Retinitis pigmentosa', 'Treated Retina detachment', 'dry Age-related Macular Degeneration']}, {'name': 'DTL-electrode attached without energy', 'type': 'DEVICE', 'description': 'DTL-electrode attached to patient eye receives no energy from neurostimulator. Treatment times remain the same as used for each treatment arm.', 'armGroupLabels': ['Non-stimulated']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Florian Gekeler, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University-Eye-Hospital, Centre for Ophthalmology, D-72076 Tübingen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okuvision GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-11-08', 'type': 'RELEASE'}, {'date': '2013-12-30', 'type': 'RESET'}, {'date': '2015-10-14', 'type': 'RELEASE'}, {'date': '2015-11-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Okuvision GmbH'}}}}