Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-03-06 @ 7:41 PM
Study NCT ID:
NCT01790958
Status:
COMPLETED
Last Update Posted:
2013-02-13
First Post:
2013-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microcurrent Stimulation to Treat Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D000080362', 'term': 'Stargardt Disease'}, {'id': 'D012174', 'term': 'Retinitis Pigmentosa'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-11', 'studyFirstSubmitDate': '2013-02-11', 'studyFirstSubmitQcDate': '2013-02-11', 'lastUpdatePostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure visual acuity after receiving microcurrent stimulation treatments.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Retinal Diseases', "Stargardt's Disease", 'Retinitis Pigmentosa']}, 'descriptionModule': {'briefSummary': 'Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.', 'detailedDescription': "This is an observational study in which data will be collected from a group of patients with retinal diseases such as Dry Macular Degeneration, RetinitisPigmentosa, and Stargardt's Disease, who have opted to receive Microcurrent Stimulation Therapy as an alternative treatment for their retinal condition."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with retinal disease such as Age-Related Macular Degeneration, STargardt's Disease, and Retinitis Pigmentosa", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to provide written consent and comply with follow up visits\n* Age 40 years or older\n* ETDRS best corrected visual acuity better than 5 letters\n* History of Dry Age Relted Macular Degeneration; Retinitis Pigmentosa; Stargardt's disease\n* No Anti-VEGF treatments for at least 3 months prior to study\n* No new antioxidant/vitamin supplementation for at least 3 months prior to study\n\nExclusion Criteria:\n\n* History of Non-Compliance with regular medical visits\n* Significant media opacities (exclude NS 4+) that may interfere with assessing visual acuity\n* Presence of pigment epithelial tears or rips\n* Known serious allergies to fluorescein dye\n* Presence of retinal neovascularization\n* Any treatment with an investigation agent in the past 30 days"}, 'identificationModule': {'nctId': 'NCT01790958', 'briefTitle': 'Microcurrent Stimulation to Treat Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Retina Institute of Hawaii'}, 'officialTitle': 'An Observational, Multi-Center Phase 1 Study of the Safety and Effectiveness of Frequency Specific Microcurrent Stimulation as an Alternative Treatment for Retinal Diseases', 'orgStudyIdInfo': {'id': 'RIH 1009'}}, 'contactsLocationsModule': {'locations': [{'zip': '96720', 'city': 'Hilo', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Cataract Laser Institute - Hilo', 'geoPoint': {'lat': 19.72991, 'lon': -155.09073}}, {'zip': '96815', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Retina Institute of Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96732', 'city': 'Kahului', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Cataract Laser Institute - Maui', 'geoPoint': {'lat': 20.88933, 'lon': -156.47293}}, {'zip': '96740', 'city': 'Kailua-Kona', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Cataract Laser Institute - Kona', 'geoPoint': {'lat': 19.64016, 'lon': -155.99912}}], 'overallOfficials': [{'name': 'George Papastergiou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Retina Institute of Hawaii'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Retina Institute of Hawaii', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}